Last month, the FDA announced an urgent recall of the Penumbra Jet 7 Xtra Flex Catheter, used to clear stroke-causing blood clots. This catheter is used in thrombectomy procedures for ischemic stroke. Unfortunately, in December 2020, it was recalled after 18 reported deaths in addition to dozens of injuries. If you suffered an ischemic stroke…
An MDL, or Multi-District Litigation, for the Stryker LFIT V40 hip replacement has been formed in U.S. District Court of Massachusetts, consolidating cases nationwide into a single court system. In August 2016, Stryker issued a voluntary Class 2 Recall for this particular hip implant. Stryker cited multiple complaints involving taper lock failure. Patients have complained…
The FDA has announced Zimmer Biomet’s Class 1 Recall of the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators. The reason behind the recall is a risk for chronic infections, paralysis, long-term hospitalization due to additional surgical procedures, and death. The devices, used during spinal fusion surgery, were determined to contain higher-than-allowed levels…
A Class I Recall has been issued for the HeartMate II LVAS Pocket System Controller due to a serious risk for patient injury or death.
Whether it’s liposuction or rhinoplasty, Botox or lip fillers, breast augmentations or eyelid surgeries, cosmetic procedures give many people the option to change physical features they dislike about themselves. With millions of surgical and cosmetic procedures performed in the US each year, it’s no secret plastic surgery is big business. The American Society of Plastic…
It’s been a rough year for Johnson & Johnson, which has faced a slew of lawsuits alleging its talcum powder products have caused ovarian cancer in women. Now, the corporation has found itself in hot water again after it was hit with a billion-dollar verdict over its faulty hip implants, which have caused issues for…
Hip replacement surgery is one of the most common and increasing orthopedic procedures performed each year in the United States. In 2000 there were approximately 138,700 total hip replacements performed in the United States. In a ten year time frame, this number more than doubled, and in 2010 there were approximately 310,800 of these procedures…
The 3M Bair Hugger warming blanket has been used during surgeries for years. Created by Dr. Scott Augustine and approved by the US Food And Drug Administration (FDA) in 1987, the Bair Hugger is a medical device used to warm patients during orthopedic surgeries. It releases forced, warm air over a patient’s body, under the…
ATTENTION: HEALTH WARNING Studies have shown that removable IVC filters can cause catastrophic injury, in some cases even death. We want to educate consumers on the IVC filter, the complications, and the injuries that can result. If you are a patient with an IVC filter implanted, we encourage you to speak with you primary care…
Thoratec Recently Issued a Voluntary Device Correction, What This Means for You Thoratec Corporation (NASDAQ: THOR) recently put out an Urgent Medical Device Correction Letter to hospitals across the country, informing them of a defect from their Heartmate II LVAS device, specifically the backup System Controller battery system. From the FDA Safety Recall Notification: …