SHERPA NX ACTIVE GUIDING CATHETER, 6F 100CM 3DRC, REF SA63DRCSH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 246 units of the Sherpa NX Active Guiding Catheter, 6F 100CM 3DRC model (Reference SA63DRCSH), used in cardiovascular procedures. The catheters have a potential defect where the outer coating material may extensively break down or peel away, which could expose the underlying stainless-steel braid wires underneath. The affected catheters were distributed worldwide, including to locations in the United States, Europe, Asia, the Middle East, and Africa.
The recall affects all lot and serial numbers of this product model (GTIN: 00613994823816). The source document does not specify what remedy or corrective action an affected consumer 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: 246 units Lot/code info: GTIN: 00613994823816 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.