SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL, .070", REF SA6ELGAMAL. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 17 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL, .070" (Reference SA6ELGAMAL), a device used in cardiovascular procedures. The affected catheters may experience extensive loss of the outer material, which could expose the underlying stainless-steel braid wires. This recall affects devices that were distributed worldwide, including to the United States and multiple countries in Europe, Asia, Africa, and the Middle East.
The source document does not specify a remedy or corrective action for consumers who may have been affected by this recall.
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: 17 units Lot/code info: GTIN: 00613994824783 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.