SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0, .070", REF SA6CHAMP20. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 117 units of the Sherpa NX Active Guiding Catheter, 6F CHAMP2.0, .070" (Reference SA6CHAMP20) used in cardiovascular procedures. The catheters may have extensive loss of primary segment material that exposes underlying stainless-steel braid wires on a subset of the recalled units. The affected catheters were distributed worldwide, including to the United States and multiple countries across Europe, Asia, Africa, and the Middle East.
The recall affects all lot and serial numbers of this product (GTIN: 00613994823366). The source document does not specify a remedy or corrective 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: 117 units Lot/code info: GTIN: 00613994823366 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.