Unsafe Medical Devices
Each year, The U.S. Food and Drug Administration (“FDA”) receives several hundred thousand reports of malfunctions, serious injuries and deaths suspected of being associated with defective medical devices. These reports — known as “Adverse Event Reports” — sometimes lead to recalls of dangerous or defective medical devices.
If a medical device manufacturer discovers a defect in one of its products, the manufacturer is required to notify the FDA and the public. This duty begins with the development of the medical device, and it continues for as long as the medical device remains on the market. If a medical device manufacturer fails to properly to notify the FDA and the public of a defect with one of its products, it can held responsible for illnesses, injuries and deaths caused by the faulty medical device.
For more information, see our Unsafe Medical Device FAQ.
Often, medical devices are implanted in the body. If a defective medical device is discovered after the device has been implanted, the device sometimes must be removed from the body, or “explanted.” This procedure is called a “revision surgery” and it subjects the patient to additional pain, risk of infection and prolonged rehabilitation.
If you or a loved one has been harmed by a unsafe medical device, contact us for a free consultation.
RECENT BLOG POSTS FOR DEFECTIVE MEDICAL DEVICES
On May 22, 2018, Stryker Orthopedics updated its Stryker LFIT V40 Femoral Head Recall to include eight (8) additional catalog numbers. The original recall occurred in August 2016 and included seven (7) catalog numbers which represented close to 45,000 devices in...read more
Baxter Minicap dialysis injuries include peritonitis, a dangerous blood infection that can lead to organ failure and death. In January 2015, the manufacturer of Baxter Minicap dialysis products notified healthcare providers and consumers of these problems. The...read more
Bard IVC filter injury occurs when the IVC filter fractures, despite being designed to protect patients from dangerous blood clots. These medical devices are implanted in the inferior vena cava to keep blood clots from traveling throughout a patient's body. Hundreds...read more
Defective medical devices update: The FBI has launched an investigation into whether a medical device manufacturer was aware that use of the surgical device was potentially dangerous.The FBI investigation is focusing on the danger surrounding use of power...read more
Defective medical devices: Some physicians have been informing patients who received Zimmer Persona Trabecular Metal knee implants that the implants have been recalled by the company.In March of this year, Zimmer, Inc. issued a voluntary recall of the Persona...read more
Defective medical devices update: In March 2015, the United States Food and Drug Administration issued a recall for nearly 12,000 Zimmer Persona Trabecular Metal Tibial Plate knee implants. One month earlier, Zimmer sent an Urgent Medical Device Recall notification...read more