SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR2.0 .070", REF SA6SAR20. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling the Sherpa NX Active Guiding Catheter, 6F SAR2.0 .070" (Reference SA6SAR20), a device used in cardiovascular procedures. The recall affects a subset of these 6-French catheters that may experience extensive loss of the outer primary segment material, which could expose the underlying stainless-steel braid wires. A total of 6 units were distributed worldwide to 27 countries and regions, including the United States, various European nations, Hong Kong, Saudi Arabia, South Africa, Taiwan, and the United Kingdom. All lot and serial numbers of this product are included in the recall.
The recall notice does not specify a remedy or corrective action for affected consumers to 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: 6 units Lot/code info: GTIN: 00613994822635 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.