When a medical device fails, the consequences can be devastating. Devices intended to save lives and improve health can sometimes cause serious injury — even death — due to defects in design, manufacturing, or labeling. While FDA approval is meant to ensure safety, it doesn’t guarantee that a device won’t cause harm once it’s in widespread use.
Understanding Medical Device Recalls
The U.S. Food & Drug Administration (FDA) classifies medical device recalls by risk level. A Class I recall indicates a reasonable probability of serious injury or death, while Class II and III recalls indicate lesser risks but still serious concerns. Recalls can be voluntary by manufacturers or mandated by the FDA.
Why Devices Fail
Medical device failures stem from issues such as:
- Defective design — flaws built into the product from the beginning
- Manufacturing defects — problems that occur during production
- Failure to warn or inadequate instructions — leaving patients unaware of risks
- Misleading marketing or claims
Notable Examples of Medical Device Litigation
Recent high-profile cases show the broad scale and impact of defective device litigation. For example:
- Sleep apnea machines: A multinational company agreed to pay over $1.1 billion to resolve lawsuits over recalled respirators that could emit harmful debris into patients’ airways.
- Knee, hip, and shoulder implants: A major implant-maker filed for bankruptcy amid thousands of injury lawsuits after a voluntary recall related to defective packaging.
- Hernia mesh litigation: Manufacturers have settled tens of thousands of claims alleging harm from defective mesh products.
These cases highlight both the legal complexity and potential compensation available when patients are harmed by defective medical devices.
Your Legal Rights After a Defective Device Injury
Even if a device has been recalled, injured patients may still have legal options. A recall does not automatically bar you from filing a lawsuit — it often strengthens your case for compensation for medical bills, lost earnings, and pain and suffering.
What Should Injured Patients Do Next?
If you believe a medical device caused harm:
- Seek Medical Attention Immediately — Your health comes first. Document injuries and treatment.
- Preserve Evidence — Save the device, packaging, manuals, and any recall notices.
- Document Everything — Take photos of injuries, gather medical records, and keep detailed notes.
- Contact an Experienced Attorney Right Away — Time limits (statutes of limitations) vary by state. Consult a firm experienced in defective device litigation as soon as possible to protect your rights.
Medical devices play a critical role in modern health care — but when they fail, the legal system exists to hold manufacturers accountable. If you or a loved one has suffered injury from a device that was recalled, failed, or caused unexpected harm, you deserve full compensation for your losses. Contact an experienced product liability attorney to explore your options.
