SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1, .070", REF SA6MP1. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular has recalled 746 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1, .070" (Reference SA6MP1), a device used for cardiovascular procedures. The recall affects units distributed worldwide, including to the United States and numerous countries across Europe, Asia, and Africa. The catheter has a potential defect where the outer material may extensively deteriorate, which could expose the underlying stainless-steel braid wires underneath.
This defect could create complications during cardiovascular procedures if the exposed wires come into contact with blood vessels or other tissue. The recall covers all lot and serial numbers of this product. The source document does not specify what remedy or action affected consumers should take.
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: 746 units Lot/code info: GTIN: 00613994821904 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.