SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070", REF SA6ECR40SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling the SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070" (a medical device used in cardiovascular procedures) because a subset of these catheters may experience extensive loss of the outer material layer, which could expose underlying stainless-steel braid wires. The affected product was distributed worldwide to 25 countries including the United States, with 4 units recalled across all lot and serial numbers bearing GTIN 00613994824813.
The source does not specify a remedy or recommended 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: 4 units Lot/code info: GTIN: 00613994824813 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.