SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5 SH, 100CM.070", REF SA6CHAMP05SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 6 units of the Sherpa NX Active Guiding Catheter, 6F model (CHAMP0.5 SH, 100CM.070") used in cardiovascular procedures. The devices were distributed worldwide to multiple countries including the United States, Austria, Belgium, France, Germany, Italy, and others. The problem involves a potential loss of material from the outer coating on some of these catheters, which could expose the underlying stainless-steel braid wires underneath.
The exposure of the internal braid wires could potentially cause harm during use in medical procedures. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
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: 6 units Lot/code info: GTIN: 00613994823427 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.