SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30. 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 CHAMP3.0, .070" (Reference SA6CHAMP30), a device used in cardiovascular procedures. A subset of these 6F Sherpa catheters has a potential defect where extensive loss of the outer material layer could occur, which would expose the underlying stainless-steel braid wires inside the catheter. Twelve units were distributed worldwide to customers in the United States and 24 other countries, including Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, and the United Kingdom.
The recall notice does not specify a remedy or corrective action for 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: 12 units Lot/code info: GTIN: 00613994823304 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.