SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0, .070", REF SA6EBU50. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 143 units of its Sherpa NX Active Guiding Catheter (6F EBU5.0, .070", Reference SA6EBU50) used in cardiovascular procedures. The catheters have a potential defect where the outer material may extensively deteriorate, exposing the underlying stainless-steel braid wires beneath. The affected devices were distributed worldwide to hospitals and medical facilities in the US and 24 other countries.
The record does not specify a remedy or recommended 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: 143 units Lot/code info: GTIN: 00613994824608 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.