SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0, .070", REF SA6EBU40. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 7,839 units of the Sherpa NX Active Guiding Catheter (6F EBU4.0, .070", REF SA6EBU40) worldwide due to a potential defect affecting a subset of these cardiovascular devices. The problem involves possible extensive loss of primary segment material that could expose underlying stainless-steel braid wires, creating a safety hazard. The affected devices were distributed to the United States and 24 other countries including Austria, Belgium, France, Germany, Italy, Spain, and the United Kingdom.
The recall notice does not specify a remedy or instructions for affected consumers to follow.
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: 7839 units Lot/code info: GTIN:00613994823526 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.