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Medtronic Recalls 6 French Sherpa NX Active Guide Catheters

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Medical device company Medtronic, on Tuesday, recalled all models of its 6 French Sherpa NX active guide catheters due to separation and fragmentation issues.

According to the company, the catheter has a potential risk of outer material separating from the device exposing the underlying stainless-steel braid wires. The detached fragments, that could remain in the patients' bloodstream, together with the attempts to retrieve the broken pieces, could result in blockage of blood vessels, injury to blood vessel walls, development of blood clots, embolism, heart attack or death.

Medtronic said it received five customer complaints and no serious injuries or deaths were reported. The company said the recall does not affect the Medtronic launcher coronary guide catheter or other Medtronic coronary stents, balloons or implantable devices.

The FDA identified this as class I recall as the use of these devices may cause serious injuries or death.

The recall is applicable to the catheters manufactured from March 10, 2017, to March 14, 2019, and distributed between April 3, 2017, and April 4, 2019. Around 1 lakh devices are being recalled.

The 6 French Sherpa NX active guide catheter is used to access veins and arteries inside and outside the heart.

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