Medical Device Injury

Injured by a defective medical device?

When medical devices fail, the consequences can be life-altering. Manufacturers have a legal duty to ensure their products are safe.

If a device malfunction caused you serious injury, you may be entitled to compensation.

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FDA Actions, 2010–2025

Multiple Class I and II recalls have been issued.

Class I is the FDA’s most serious recall, indicating a reasonable probability of serious injury or death.

Multiple Class I and II recalls and safety warnings have been issued for a range of medical devices over the years. These recalls and warnings may relate to device malfunctions, manufacturing issues, labeling concerns, or other safety risks identified through ongoing regulatory review and adverse event reporting.

FDA Class I · 2025

Bausch + Lomb enVista Aspire, Envy & Monofocal Intraocular Lenses (IOLs)

On April 3, 2025, Bausch + Lomb initiated a voluntary recall of all U.S. lots of its enVista Aspire, enVista Envy, and enVista monofocal IOLs (including toric variants) after 44 reports of toxic anterior segment syndrome — 35 of which occurred in 2025 alone. The company traced 90% of TASS cases to raw material from a single vendor. The FDA upgraded the action to Class I in May 2025. Lawsuits: Multiple firms have opened intake for plaintiffs experiencing TASS, post-operative inflammation, and revision surgery; litigation is in early stages as of 2026.

The FDA designated this a Class I recall on April 17, 2026, with 476 serious injuries reported.

FDA safety alert — bausch-lomb-announces-voluntary-recall-envista-aspiretm-envista-envytm-and-certain-envistar FDA recall record (enVista) FDA recall record (Bausch + Lomb 2025)

FDA Class I · 2025

Philips Respironics CPAP, BiPAP & Ventilators

In June 2021, Philips recalled approximately 15 million CPAP, BiPAP, and mechanical ventilator devices worldwide after determining that the PE-PUR sound-abatement foam could degrade into particles and gases patients may inhale or ingest, with potential carcinogenic effects. The FDA designated the action a Class I recall and has since logged more than 116,000 medical device reports tied to the devices.

Lawsuits: MDL 3014 (W.D. Pa., Judge Joy Flowers Conti). A $1.1 billion personal-injury settlement was approved in September 2024, the largest medical device settlement in recent U.S. mass-tort history, with approximately 58,000 claimants registered.

FDA recall page — recalled-philips-ventilators-bipap-machines-and-cpap-machines FDA safety alert — problems-reported-recalled-philips-ventilators-bipap-machines-and-cpap-machines FDA Class I device recall record (DreamStation ASV / ST / AVAPS)

FDA Class II · 2010

DePuy ASR XL Acetabular Hip Implant System (Johnson & Johnson)

On August 24, 2010, DePuy Orthopaedics recalled the ASR XL Acetabular and ASR Hip Resurfacing systems — roughly 93,000 metal-on-metal implants globally (about 37,000 U.S.) — after registry data showed a 1-in-8 failure rate at 5 years. The metal-on-metal articulation shed cobalt and chromium debris, causing metallosis, pseudotumors, bone loss, and revision surgery.

Lawsuits: MDL 2197 (N.D. Ohio). J&J/DePuy paid roughly $4 billion to settle ~8,000 cases in 2013 and $420 million to settle ~1,800 more in 2015, with total DePuy hip settlements and verdicts reaching approximately $6.2 billion. About 119 cases remained pending in MDL 2197 as of April 2026.

FDA recall record (DePuy ASR XL Acetabular Cup) FDA recall record (DePuy ASR 300 Acetabular Cup) FDA recall record (DePuy ASR Resurfacing Femoral Heads)

FDA Sales Restriction & Market Withdrawal · 2018

Bayer Essure Permanent Birth Control System

In April 2018, the FDA restricted sales of Essure — a non-surgical permanent contraceptive consisting of two metal coils placed in the fallopian tubes — and required a black-box patient checklist after roughly 26,773 problem reports, including chronic pain, organ perforation, device migration, and unintended pregnancy. Bayer withdrew the product from the U.S. market in December 2018.

Lawsuits: Approximately 39,000 U.S. claims filed. In August 2020, Bayer reached a $1.6 billion settlement covering roughly 90% of pending and unfiled claims, averaging about $45,600 per plaintiff.

FDA activities FDA brief Bayer announcement

Common Injuries

Injuries that may support a legal claim

When a medical device fails to perform as intended, the consequences can be severe and sometimes permanent.

Surgical Complications

Device failures during/after surgery can lead to infection, additional procedures, and prolonged recovery.

Organ Perforation or Damage

Mesh and IVC filters have been linked to perforation of surrounding tissue and organs.

Loss of Device Function

Cardiac and neurological devices that fail to operate can leave patients at immediate risk of serious medical events.

Chronic Pain & Nerve Damage

Implants that migrate, fracture, or degrade can cause lasting nerve damage and debilitating pain.

Hospitalization & Revision Surgery

Many device failures require emergency hospitalization and costly revision or removal surgeries.

Injured by a defective medical device?

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