Cook Medical has announced a catheter recall involving 95,167 devices around the world
Cook Medical recall involves 95,167 devices
Based in Bloomington, Indiana, Cook Medical initiated the voluntary recall on July 2.
The recall involves 2,239 lots of Beacon tip angiographic catheters that could split or separate.
FDA databases do not yet feature the recall and an FDA spokesman did not immediately have information about whether the agency has classified it.
The problem with Beacon catheters involves tip splitting or separation, which has resulted in adverse events, according to Cook Medical.
The company has received 26 complaints of catheter-tip splitting and separation however, Cook Medical says there have been 14 medical device reports to date in which a tip split or separation occurred.
Tip splitting could lead to loss of device function, according to the company.
Tip separation may require medical intervention to retrieve a separated segment.
A tip separation might also occlude blood flow to end organs.
Cook Medical says customers and distributors have been notified with recall notification letters requesting that they stop using the devices and return them.
FDA and other regulatory agencies around the world have also been notified.
Specific lot numbers are available with the Cook news release.