SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL405. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 330 units of SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070" (Reference SA6JL405) distributed worldwide to multiple countries including the US, Europe, Asia, and the Middle East. The catheters have a potential defect where the outer material may extensively break down, which could expose underlying stainless-steel braid wires.
The recall affects all lot and serial numbers of this product model. The record does not specify a remedy or recommended course of 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: 330 units Lot/code info: GTIN: 20613994822196 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.