Some CrossCath Catheters Recalled, Radiopaque Rings May Fail

Medscape
18 Dec, 2019 ,

The US FDA has announced that six lots of its CrossCath Support Catheter, will be recalled as Class I. The recall, which affects 117 catheters distributed from September 3 to September 19 of this year, stems from identification of a manufacturing error involving their radiopaque marker rings, which, depending on the model, may be affixed to the devices too loosely or too tightly.

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Cook Medical has issued a recall of six lots of its CrossCath Support Catheter. The US Food and Drug Administration (FDA) has labeled the recall as class I, the agency has announced.

The recall, which affects 117 catheters distributed from September 3 to September 19 of this year, stems from identification of a manufacturing error involving their radiopaque marker rings, which, depending on the model, may be affixed to the devices too loosely or too tightly.

Affected customers were notified on November 8, the FDA said.

"Marker bands that are too loose can dislodge from their original position and marker bands that are too tight can cause buckling" of the catheter during procedures.

The problems could prolong the procedure as corrective measures are taken, the agency noted. "There is also the potential that the separated marker band cannot be retrieved, and it can cause permanent impairment like loss of limb; or the fragment can obstruct blood flow."