Another Catheter Class I Recall, This Time For Vascular Solutions
US regulators have announced a second serious recall for a faulty catheter in the past month. The problem with Vascular Solutions’ catheter seems to be similar to Boston Scientific’s recall earlier this month, where a part of the device may break off and get stuck in the patient.
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US regulators are proposing updates to a guidance document they finalized in February for devices used to clear arteries of plaque. The updated language specifically addresses software interoperability, pyrogenicity and certain performance-testing requirements.
Boston Scientific has recalled more than 6,000 angiographic catheters because the tip can fall off and get stuck in patients, potentially causing serious injury or death. The company says customers should immediately stop using the lots associated with the faulty products and return them.
The purchase price of $56 a share in cash is a modest 16% premium over Vascular Solutions' 90-day average price. Vascular Solutions' CEO says uncertainty about the future leadership of the company compelled it to consider acquisition offers.