SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII, .070", REF SA6HSIII. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling Sherpa NX Active Guiding Catheters (6F HSIII, .070") because a subset of these devices may experience extensive loss of the outer material layer, which could expose the underlying stainless-steel braid wires. The affected catheters were distributed worldwide to 26 countries including the United States, and a total of 6 units are subject to this recall across all lot and serial numbers matching GTIN 00613994824158.
The recall notice does not specify a remedy or what consumers should do in response.
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: 00613994824158 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.