| MEDICAL DEVICE |
ISSUE |
|
Alere InRatio
|
The use of the Alere INRatio and INRatio 2PT/INR Monitor System and INRatio Test Strips were associated with incorrect INR readings.
|
|
Attune Knee
|
Surgical glue failed to properly hold the device to a patient’s tibia bone.
|
|
Depuy Hip
|
On August 24, 2010, DePuy Orthopedics issued a recall of the ASR XL Acetabular System and ASR Hip Resurfacing System, as they were failing at a higher rate than other types of hip replacements.
|
|
Essure
|
Hundreds of claims were filed against Bayer and Conceptus Inc. by women who suffered severe abdominal damage when their Essure birth control device moved and punctured the uterus and fallopian tubes.
|
|
Guidant
|
In 2005 Guidant issued safety warnings on 11 models of defibrillators because of malfunctions with the magnetic switch inside the device getting stuck and preventing the device from providing treatment.
|
|
Medronic Defibrillator Wire
|
In 2007, Medtronic announced that several of the electrical wires it sold were defective and may have contributed to the deaths of at least five patients by failing to deliver a necessary shock.
|
|
Nuvaring
|
Nuvaring is a “third-generation” hormone contraceptive that has been associated with Stroke, Heart Attack, Deep Vein Thrombosis, Myocardial Infarction, Cerebrovascular Accidents, Pulmonary Embolism, Death.
|
|
Olympus Video Colonoscope
|
The Olympus Colonoscope can be difficult to properly clean after each use, which results in the device spreading a bacterial infection from one patient to another.
|
|
Ortho Evra
|
On November 10, 2005, Ortho McNeil, a division of Johnson & Johnson, warned millions of women using Ortho Evra that the birth control patch exposes them to significantly higher doses of hormones and may put them at greater risk for blood clots.
|
|
Power Morcellators
|
Power Morcellators have been associated with an increased risk of significantly upstaging undiagnosed cancer during laparoscopic uterine fibroid removal surgeries.
|
|
Prisma Dialysis
|
The Prisma CRRT is a type of kidney dialysis system used in hospital intensive care units for critically ill patients. The FDA became aware of serious injuries and deaths associated with the use of the device in August 2005.
|
|
St. Jude Defibrillator
|
The St. Jude Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Devices manufactured between 2010 and 2015 had issues with the battery prematurely failing without giving proper warning.
|
|
Stryker Hip
|
The Stryker hip recalls involve the LFIT Anatomic V40 femoral head utilized in the Stryker Accolade, and also the Rejuvenate and ABG II hip modules.
|
|
Transvaginal Mesh
|
In July 2011, the FDA issued heightened warnings regarding the use of transvaginal mesh for the repair of pelvic organ prolapse.
|
|
Zimmer Hip
|
In July 2008, Zimmer Holdings announced that it was suspending sales of the Durom acetabular cup, an artificial hip component, as a result of high implant failure rates.
|
|
Zimmer Knee
|
In September 2010, the FDA issued a recall on one particular Zimmer knee replacement product known as NexGen MIS.
|
|
Zimmer Shoulder
| The Zimmer Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340 manufactured between August 2008 and September 2011 was the subject of a recall. |
