SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling Sherpa NX Active Guiding Catheters (model 6F MAC4.0 SH, .070") used in cardiovascular procedures. The catheters may lose material from their outer coating, which could expose underlying stainless-steel wire braid. This defect affects a small number of units distributed worldwide, including locations in the United States and multiple other countries.
The recall affects all lot and serial numbers of this product (GTIN: 00613994822017). The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Reason for recall: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. 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 Quantity: 3 units Lot/code info: GTIN: 00613994822017 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.