SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5, .070", REF SA6ECR35. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 14 units of the Sherpa NX Active Guiding Catheter, 6F ECR3.5, .070" model used in cardiovascular procedures. The catheters have a potential defect where the outer primary segment material may extensively break down, which could expose the underlying stainless-steel braid wires. The affected catheters were distributed worldwide, including to the United States and multiple European and Asian countries.
The recall affects all lot and serial numbers of this product model identified by GTIN 00613994824455. The source document does not specify a remedy or action that 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: 14 units Lot/code info: GTIN: 00613994824455 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.