SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 3,302 units of Sherpa NX Active Guiding Catheter (6F AL1.0, .070") due to a potential defect where the outer material layer may wear away extensively, exposing the underlying stainless-steel braid wires beneath. The affected catheters were distributed worldwide to 25 countries and territories including the United States, various European nations, and parts of Asia.
The recall notice does not specify a remedy or instructions for what consumers should do regarding the recalled product.
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: 3302 units Lot/code info: GTIN: 00613994823786 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.