SHERPA NX ACTIVE GUIDING CATHETER, 6F MB2, .070", REF SA6MB2. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 80 units of Sherpa NX Active Guiding Catheter, 6F MB2, .070" (Reference SA6MB2) that were distributed worldwide to multiple countries including the US, Europe, Asia, and the Middle East. The catheters pose a potential safety hazard in which the outer material layer may extensively deteriorate, exposing underlying stainless-steel braid wires that could cause injury during cardiovascular procedures.
The recall affects all lot and serial numbers of this product, identified by GTIN 00613994821928. The source document does not specify what remedy or action affected consumers should take.
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: 80 units Lot/code info: GTIN: 00613994821928 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.