SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1 SH, .070", REF SA6MP1SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 121 units of the Sherpa NX Active Guiding Catheter (6F MP1 SH, .070") worldwide due to a potential defect affecting a subset of these devices. The problem involves extensive loss of material from the primary segment, which could expose underlying stainless-steel braid wires. The affected catheters were distributed to medical facilities in the United States and 24 other countries including Austria, Belgium, France, Germany, Italy, and the United Kingdom, among others.
The recall affects all lot and serial numbers of this catheter model (GTIN: 00613994821874). The source document does not specify a remedy or what actions affected consumers should take in response to 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: 121 units Lot/code info: GTIN: 00613994821874 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.