SHERPA NX ACTIVE GUIDING CATHETER, 6F FR4.0, .070", REF SA6FR40. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 10 units of the Sherpa NX Active Guiding Catheter (6F FR4.0, .070", REF SA6FR40) due to a potential defect in which the outer material may extensively deteriorate and expose the underlying stainless-steel braid wires. The affected catheters were distributed worldwide to multiple countries including the United States, Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, and the United Kingdom, among others.
The recall notice does not specify a remedy 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: 10 units Lot/code info: GTIN: 00613994824196 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.