SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 SH, .070", REF SA6MAC30SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 16 units of the Sherpa NX Active Guiding Catheter (6F MAC3.0 SH, .070") used in cardiovascular procedures. The catheters have a potential defect where the outer coating material may extensively wear away, exposing the underlying stainless-steel braid wires. The affected product has GTIN 00613994821751 and includes all lot and serial numbers for this model.
The recalled catheters were distributed worldwide, including to facilities in the United States and 24 other countries across Europe, Asia, the Middle East, and Africa. The recall notice 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: 16 units Lot/code info: GTIN: 00613994821751 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.