SHERPA NX ACTIVE GUIDING CATHETER, 6F MP ST, .070", REF SA6MPST. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular has recalled 76 units of the Sherpa NX Active Guiding Catheter, 6F MP ST, .070" (Reference SA6MPST) worldwide due to a potential defect affecting a subset of these devices. The problem involves possible extensive loss of the primary segment material, which could expose underlying stainless-steel braid wires. The affected devices were distributed to numerous countries across North America, Europe, Asia, Africa, and the Middle East.
The recall affects all lot and serial numbers of this product, identified by GTIN 00613994823069. The recall notice does not specify a remedy or corrective 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: 76 units Lot/code info: GTIN: 00613994823069 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.