After a suspected device failure, the order of operations matters more than speed. See your treating clinician first, because every decision about the device itself belongs to them. Then find out who physically has the device, which after an explant is usually the hospital rather than you. Capture the device identifiers from your implant card and operative report. Do not return the device to the manufacturer or its representative, and do not give a recorded statement or sign a release before getting advice. You can then look up the device yourself in three public FDA databases, and a lawyer can work out which claims the facts support and which deadline governs.
Two things this article deliberately does not do. It names no devices and asserts no link between any device and any medical outcome, because that is a scientific question that changes as evidence develops and a law firm’s webpage is not a reliable source for it. And nothing here is medical advice: no one should stop treatment, seek removal of a device, or change anything clinical because of something they read online. For the general product liability framework, see our California defective product lawyer page. To talk through a situation, call our San Mateo office at 650-250-0705.
Key Takeaways
- Clinical decisions about a device are for your treating clinician. The legal steps run alongside that, not instead of it.
- After an explant, the hospital or surgical facility usually controls the device. Asking who has it, in writing, is an early and often decisive step.
- Your device has a unique identifier, and FDA maintains public databases that let you look it up, see reported adverse events, and find which regulatory pathway it went through.
- A claim against a manufacturer and a claim against a clinician or facility are different claims with different rules and different deadlines.
- An adverse event report is not proof of causation, and a page that suggests otherwise is overselling it.
Step 1: Medical Care, and the Record It Creates
Beyond the obvious reason, treatment creates the contemporaneous record that connects what happened to the device. Tell the clinician what you experienced and when, so that it appears in the notes rather than in a recollection months later.
Whether a device should be removed, replaced, monitored, or left alone is entirely a clinical judgment. If you are considering a second medical opinion, that is a conversation with clinicians, not with a lawyer.
Step 2: Find Out Who Has the Device
This is the step almost every article on this topic skips, and it is the one most likely to decide whether a manufacturing defect theory survives.
If a device was explanted, you probably do not have it. Facilities handle removed devices in different ways: some retain them, some send them to pathology, some return them to the manufacturer for analysis, and some dispose of them as medical waste under their own protocols. The manufacturer’s representative may also request the device for “evaluation.”
So the practical action is to ask, in writing and promptly, who is holding the explanted device and to request that it be preserved and not released to anyone. A lawyer can send that request to the facility and the manufacturer at the same time. Once a device has gone back to the company that made it, an independent examination becomes very difficult.
If the device was external rather than implanted, the same principle applies with fewer complications: keep it, along with its packaging, accessories, charger, and printed materials, unaltered.
Step 3: Capture the Identifiers
You cannot investigate a device you cannot identify to the model and lot level. Collect:
- The patient implant card, if you were given one
- The operative report and implant log from the procedure, which normally record the manufacturer, model, and lot or serial number
- The unique device identifier. Under FDA’s UDI system, the label of most devices carries a unique device identifier in both human-readable and machine-readable form
- Packaging and printed materials for an external device
Step 4: Look the Device Up Yourself
Three FDA resources are public and usable by patients, and no competing page on this topic points to them.
- AccessGUDID is a searchable database of device identification information drawn from FDA’s Global Unique Device Identification Database. FDA states it is available for anyone, including patients and caregivers. It holds the device identifier portion of the UDI, along with the device name, company name, and related information.
- MAUDE, the Manufacturer and User Facility Device Experience database, is a searchable database of medical device reports of adverse events covering the last ten years, with older reports on FDA’s MDR data files pages. It contains reports from mandatory reporters such as manufacturers, importers, and device user facilities, and voluntary reporters including clinicians, patients, and consumers.
- FDA’s device approvals and clearances databases let you find which marketing pathway a device went through. FDA’s Center for Devices and Radiological Health maintains searchable databases of premarket notification and premarket approval decisions.
An honest caveat, because it matters. MAUDE is a passive reporting system. A report in it does not establish that a device caused anything, reports vary enormously in detail, and volume differs by device category for reasons unrelated to risk. Finding reports is a reason to investigate, not a conclusion. Any page that treats a MAUDE hit as proof of a claim is overselling it.
Step 5: What Not to Do
- Do not return the device to the manufacturer, a sales representative, or a supplier, and do not agree to have it collected for evaluation, before getting advice.
- Do not give a recorded statement to the manufacturer or its insurer.
- Do not sign a release, including one attached to an offer of a refund, a replacement device, or reimbursement of costs.
- Do not discard packaging, cards, or paperwork, even if the device itself is gone.
- Do not rely on a recall, or on the absence of one. Products can be defective whether or not a recall has issued, and a recall does not by itself establish what caused a particular injury.
Step 6: Request the Records, From Both Custodians
Device cases involve two separate record sets held by different people:
Clinical records sit with the treating clinicians and the facility: the operative report, implant log, imaging, follow-up notes, and the record of what was reported and when. These are yours to request.
Device records sit with the manufacturer: design history, testing and validation data, complaint files, and internal risk assessments. Those are not obtainable by request. They come through formal discovery, which is one reason device cases are more often filed than settled early, and why the process runs longer than an ordinary injury claim. Our article on how a product liability lawsuit proceeds covers that stage.
Step 7: Work Out Which Claim, Against Whom
This is the step that determines everything about timing, and it is where a device case differs from an ordinary product case.
| Potential defendant | Type of claim | Deadline framework |
| The device manufacturer | Product liability: typically failure to warn, and sometimes manufacturing or design theories | Generally the two-year injury deadline |
| The implanting or treating clinician, or the facility | Professional negligence, if the selection, implantation, or monitoring fell below the standard of care | A separate limitations framework for professional negligence |
| A distributor or supplier | Product liability, depending on the role in the chain | Generally the two-year injury deadline |
| A public hospital or health district | Either of the above, plus a claim presentation requirement | A written claim to the entity generally comes first, on a much shorter timeline |
Some situations involve more than one of these, and they do not run on the same clock. That last row is easy to miss: if the procedure happened at a publicly operated hospital or district facility, a claim presentation requirement may apply before any lawsuit.
Why the Device’s Regulatory Pathway Matters
Devices do not all reach the market the same way, and which route a device took is a checkable fact rather than a matter of opinion.
FDA describes premarket approval as the most stringent type of device marketing application it requires. A premarket notification, commonly called a 510(k), is a submission demonstrating that a device is substantially equivalent to a device already legally marketed. There are further routes, including the De Novo classification pathway for novel devices of low to moderate risk, and the humanitarian device exemption for devices intended for conditions affecting fewer than 8,000 individuals in the United States per year.
Manufacturers routinely point to a device’s FDA status in response to a claim. How far that affects any particular claim is a contested and technical legal question that depends on the device, the pathway it went through, and the theory being advanced. It is not something an article can resolve in either direction, and any page telling you FDA approval either ends your claim or means nothing at all is oversimplifying. What you can do is find out which pathway applied, and hand that to a lawyer.
Deadlines
| Situation | General rule | Source |
| Injury claims against a private party, including a manufacturer | Two years | Code Civ. Proc., § 335.1 |
| Claims based on a health care provider’s professional negligence | Three years after the date of injury or one year after the injury is discovered (or reasonably should have been), whichever occurs first, subject to statutory exceptions | Code Civ. Proc., § 340.5 |
| Claims where a public entity may be responsible, including a public hospital or district | A written claim generally must be presented within six months | Gov. Code, § 911.2 |
Device injuries raise a timing complication worth naming: the harm is often recognized long after the device was implanted. When a deadline began to run in that situation is a fact-specific legal question, and it is not safe to assume either that the clock started at implantation or that it started when you learned of the problem. If you think you may be out of time, that is a reason to ask rather than to stop.
Device Injury Claims in San Mateo County
Our office at 15 North Ellsworth Avenue, Suite 105, San Mateo, CA 94401 works with injured people across the Peninsula. Civil cases here are handled by the Superior Court’s Civil Division at the Hall of Justice, 400 County Center, Redwood City.
More about the office is on our San Mateo page, and related explanations are collected in our California personal injury guides.
How Vaksman Khalfin Can Help
Vaksman Khalfin, PC handles California personal injury and product liability claims, including defective product matters, and can review a device situation to identify what kind of claim the facts support, which potential defendants are viable, which limitations framework governs, and what needs to be preserved. That includes sending preservation requests to a facility and a manufacturer at the same time, which is usually the most time-sensitive step.
Where a matter is better suited to a practice that concentrates on large-scale medical device litigation, we will say so at the consultation rather than after.
The firm’s California personal injury practice is led by Alan D. Khalfin, admitted in California. Injury matters are handled on a contingency-fee basis: there is no upfront attorney’s fee, and attorney’s fees are owed only if there is a recovery. Case costs, which in device matters frequently include expert medical and engineering analysis, are a separate category from attorney’s fees. How case costs are handled, including whether you may be responsible for them, is set out in the written fee agreement reviewed with you before anything is signed.
To talk through a device injury, call 650-250-0705 or schedule a free consultation. Bring the implant card and any operative paperwork you have.
Reviewed by Alan D. Khalfin, Partner and Managing Attorney, Vaksman Khalfin, PC (admitted in California). Last reviewed: 09/22/2026
Frequently Asked Questions
Yes, where a defective device caused injury. California recognizes strict liability claims, which focus on whether the product was defective and whether the defect caused harm rather than on whether the company was careless, and negligence and warranty theories may also apply. Whether a particular situation supports a claim depends on the device, the facts, and what evidence still exists.
There is no reliable figure, and no lawyer can responsibly quote one. Many resolutions are confidential or never reported, and published ranges combine cases with nothing in common. What determines a particular outcome is the evidence of defect and causation, the documented medical care and its effects, the fault attributed to each party, and the insurance available.
Often the hospital or surgical facility rather than you. Facilities handle explanted devices differently, and a manufacturer's representative may also request the device for evaluation. Ask in writing, promptly, who is holding it and request that it be preserved and not released. A lawyer can send that request to the facility and the manufacturer at the same time.
Start with your patient implant card if you were given one, and the operative report and implant log from the procedure, which normally record the manufacturer, model, and lot or serial number. Under FDA's unique device identification system, most device labels carry a unique device identifier. You can then search AccessGUDID, FDA's public database of device identification information, which FDA states is available to anyone including patients.
Yes. FDA's MAUDE database is a searchable record of adverse event reports involving medical devices covering the last ten years, with older reports available separately. It includes reports from manufacturers, importers, and facilities, as well as voluntary reports from clinicians and patients. Bear in mind that it is a passive reporting system: a report does not establish that a device caused anything, and report volume varies by device category for reasons unrelated to risk.
Not automatically, and not never. How far a device's FDA status affects a particular claim is a contested and technical question that depends on which marketing pathway the device went through and what theory is being advanced. Any flat answer either way is oversimplifying. Finding out the pathway is useful; drawing the legal conclusion is a lawyer's job.
Not necessarily, and the difference matters for timing. A claim against the manufacturer is product liability. A claim that a clinician's selection, implantation, or monitoring fell below the standard of care is professional negligence, which follows its own limitations framework under Code of Civil Procedure section 340.5. Some situations involve both, and they do not run on the same clock.
No lawyer can predict a particular outcome. Professional negligence claims normally require expert testimony to establish the applicable standard of care and that it was not met, and they follow their own limitations framework. That is one of several reasons the manufacturer claim and the provider claim are assessed separately.
When a deadline began to run in that situation is a fact-specific legal question. It is not safe to assume either that the clock started at implantation or that it started when you learned of the problem. If you are concerned you may be out of time, that is a reason to get an assessment rather than to conclude the matter is closed.
