Cook Medical said today it expanded its recall of its Beacon Tip angiographic catheters to include all lots of select sizes of the catheters.
The recall is based on 42 medical device reports of the tips splitting or separating, which leads to loss of device function and can require medical intervention or face the potential of occluded blood flow to end organs, the company said.
Cook expanded the recall to include versions of the Torcon NB advantage Beacon tip catheters, under catalog prefixes HNBR4.0, HNBR4.1 and HNBR5.0 units with the RUC suffix, Royal Flush Plus Beacon tip high-flow catheters, under catalog prefix HNR4.0, Slip-Cath Beacon tip hydrophilic catheters, with catalog prefixes SCBR4.0, SCBR4.1 and SCBR5.0 units with the RUC suffix and Shuttle Select Slip-Cath catheters with the catalog prefix SCBR4.5, according to the company.
In August, The FDA labeled the recall of a select number of Cook Medical’s beacon tip angiographic catheters as a Class I.
A Class I label from the FDA indicates that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
At the time, the FDA indicated that 38,895 units in the U.S. were being recalled. The recalled units were manufactured between May 9, 2013 and September 1, 2014, and distributed between June 6, 2013 and June 25, 2015, according to the agency.
Cook Medical provided a full list of the lot numbers and catalog prefixes of the recalled tips.