SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5 SH, .070", REF SA6JL45SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 51 units of the SHERPA NX ACTIVE GUIDING CATHETER (6F JL4.5 SH, .070") used in cardiovascular procedures. The recalled devices may experience extensive loss of the outer material layer, which could expose the underlying stainless-steel braid wires. These catheters were distributed worldwide, including to the United States and numerous European and international markets.
The recall affects all lot and serial numbers of this product with GTIN 00613994822086. The source document 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: 51 units Lot/code info: GTIN: 00613994822086 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.