FDA issues class 1 recall for angiography catheter following multiple injuries

The U.S. Food and Drug Administration is telling healthcare providers to stop using a specific type of angiographic catheter after its manufacturer recalled the device, the administration said Thursday.

Cordis Corporation, with U.S. headquarters in Hialeah, Florida, warned its Super Toque MB angiographic catheter with radiopaque marker bands can move during procedures and cause serious adverse events. The FDA classified the case as a class 1 recall, its most serious designation.

The global interventional vascular specialist said the catheter can dislodge when trapped between another device and vessel wall, leading to potentially major injuries.

“If this happens this could cause serious adverse events including delays in the procedure, the need for added medical procedures, heart attack, or stroke,” the FDA said in its alert.

To date, there have been 167 recorded complaints, eight injuries and no deaths. About 25,000 devices have been recalled in the U.S.

Cordis issued a letter back in July warning customers about the problem. It’s telling those with questions to email  GMB-CordisFieldAction@cardinalhealth.com or call 1-800-327-7714.

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