SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070", REF SA6CHAMP10SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 10 units of the Sherpa NX Active Guiding Catheter (6F CHAMP1.0 SH, .070") used in cardiovascular procedures. The catheters have a potential defect where the outer material layer may extensively wear away, which could expose the underlying stainless-steel wire braid. This issue affects all lot and serial numbers of this product (GTIN: 00613994823403) that were distributed worldwide to hospitals and medical facilities in the United States and 24 other countries.
The recall notice does not specify a remedy or instructions for affected consumers or healthcare providers regarding what actions they 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: 10 units Lot/code info: GTIN: 00613994823403 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.