SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5 SH, .070", REF SA6ECR35SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 11 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5 SH model (.070", REF SA6ECR35SH) worldwide. These catheters, used in cardiovascular procedures, have a potential defect where the outer material layer may extensively wear away on some units, which could expose the underlying stainless-steel braid wires beneath.
The affected catheters were distributed to medical facilities in the United States and 24 other countries including Austria, Belgium, France, Germany, Italy, and the United Kingdom. The recall applies to all lot and serial numbers of this product. The source document does not specify a remedy or instructions 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: 11 units Lot/code info: GTIN: 00613994824837 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.