In June 2021, Philips Respironics recalled millions of CPAP, BiPAP, and ventilator devices after discovering that the PE-PUR sound-abatement foam inside them could degrade, releasing particles and gases that users could inhale or swallow. The recall — one of the largest medical device recalls in history — covered machines millions of Americans used every night…
The Bard PowerPort is an implantable port catheter placed under the skin — usually in the chest — to give cancer patients and others long-term IV access for chemotherapy, medications, and blood draws. Lawsuits allege that the catheter tubing, made of polyurethane blended with barium sulfate, can degrade and grow brittle, causing the catheter to…
Exactech, a Florida-based orthopedic device maker, recalled hundreds of thousands of knee, ankle, and hip replacement components beginning in 2021 after discovering a packaging defect: the vacuum-sealed bags holding its polyethylene inserts lacked a required oxygen barrier layer. Oxygen exposure degrades polyethylene — the plastic that functions as cartilage in a joint replacement — causing…
Spinal cord stimulators (SCS) are implanted devices that deliver electrical pulses to the spinal cord to manage chronic pain, typically after back surgery has failed or other treatments have been exhausted. Boston Scientific’s systems — including the WaveWriter Alpha platform — have been implanted in thousands of patients. SCS devices as a category have generated…