SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5 SH, .070", REF SA6JL35SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 213 units of the Sherpa NX Active Guiding Catheter, 6F JL3.5 SH, .070" (Reference SA6JL35SH), a medical device used in cardiovascular procedures. The recall affects all lot and serial numbers of this product, which were distributed worldwide to 26 countries including the United States, Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom.
The recall was initiated because there is a potential for extensive loss of primary segment material on a subset of these 6F Sherpa catheters, which could expose underlying stainless-steel braid wires. The source document does not specify a remedy or required 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: 213 units Lot/code info: GTIN: 00613994822215 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.