SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 613,994 units of the Sherpa NX Active Guiding Catheter, 6F model (reference SA6AR10SH) used in cardiovascular procedures worldwide. The recalled catheters have a potential defect where the outer layer material may extensively break down, which could expose the underlying stainless-steel braid wires beneath. The affected devices were distributed to hospitals and medical facilities in the United States and 24 additional countries including Austria, Belgium, France, Germany, Italy, Spain, and the United Kingdom.
The recall affects all lot and serial numbers of this product. The source document does not specify a remedy or recommended action for affected consumers.
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: 655 units Lot/code info: GTIN: 00613994823908 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.