SHERPA NX ACTIVE GUIDING CATHETER, 6F AL4.0, .070", REF SA6AL40. 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 AL4.0, .070" (model SA6AL40), a device used in cardiovascular procedures. The recall affects 30 units distributed worldwide to countries including the United States, Austria, Belgium, France, Germany, Italy, and the United Kingdom. The problem is that a subset of these 6F Sherpa catheters may experience extensive loss of the outer material layer, which could expose the underlying stainless-steel braid wires.
The recall involves all lot and serial numbers of this device (GTIN: 00613994824004). The source document does not specify a remedy or instructions for affected consumers regarding how to proceed.
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: 30 units Lot/code info: GTIN: 00613994824004 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.