SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 1,491 units of Sherpa NX Active Guiding Catheter, 6F, AR1.0 100CM.070" (Reference SA6AR10) used in cardiovascular procedures. The catheters have a potential defect where the outer material may extensively break down, exposing the underlying stainless-steel braid wires beneath. The affected devices were distributed worldwide to medical facilities in the United States and 24 other countries.
The source document does not specify a remedy or instructions for what affected consumers or healthcare providers should do regarding 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: 1491 units Lot/code info: GTIN: 00613994823922 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.