The center is proposing that Philips repair, replace or refund recalled devices manufactured after November 2015.
The catheter is part of the company’s transcatheter pulmonary valve system.
Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods.
Some of the company’s V60 and V60 Plus ventilators were assembled with an expired adhesive, which could cause product failure.
The Class I recall affects more than 95,000 devices in the United States.
A capacitor manufacturing assembly error could cause the device to become inoperable.
FDA also supports the removal of the HeartWare HVAD System from the market.
Nearly 32,000 stent systems have been recalled in the United States.
A product issue could cause keys to become unresponsive or stuck, leading to infusion delays.
Reported issues related to the device include two injuries and one death.