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Medtronic recalls blood vessel catheters due to detached pieces

Medtronic PLC has recalled its line of catheters designed for access to veins and arteries inside and outside the heart because material from the device could detach inside the blood vessels.

Following five patient complaints, the Irish company recalled all models of its 6 French Sherpa NX Active Guide Catheter because fragments could detach and reveal stainless-steel braid wires underneath. The fragments could also be lost inside the patient, requiring retrieval.

The U.S. Food and Drug Administration gave the recall a Class I designation, the regulator's most serious.

Although the FDA said Oct. 8 that use of the devices could cause serious injury or death, none had occurred at the time of the release.

The affected catheters were manufactured from March 2017 to March 2019 and distributed from April 2017 to April 2019. The company began the recall in March and has pulled 106,298 devices so far.

Medtronic sent a revised urgent medical-device recall notice to customers in June.