Medtronic’s all-models recall of its “6 French Sherpa NX Active Guide Catheters” received a Class I designation from the FDA, meaning “use of these devices may cause serious injuries or death.”
Neither serious injury nor death were reported in the five customer complaints that inspired the recall, Medtronic said in its FDA-posted recall notice.
This recall covers 106,298 catheters.
The catheters are used for getting into veins and arteries, usually to get drugs or fluids into blood vessels. The company’s description of the catheters’ major malfunction makes plain why this problem can be fatal.
According to the company, the outer material can come off the device in pieces. That leaves stainless-steel braid wires exposed. Meanwhile, those pieces can wind up in the bloodstream. The pieces — or attempts to remove them — can result in continued blood vessel blockage, blood vessel wall injury, blood clots, embolism, heart attack and death.
Doctors, nurses and patients can report any problems to the FDA’s MedWatch either by clicking here or faxing 1-800-332 (FDA)-0178.