medical Class I Updated 2019-10-09

Medtronic Vascular recalls SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6

Recalled Product

SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. for cardiovascular use


Hazard / Issue

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Issued by

FDA

Distribution: Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom
Lot/Code Info: GTIN: 00613994821980 All Lot/Serial Numbers
View official government recall

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