SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75, .070", REF SA6MAC375. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 9 units of the Sherpa NX Active Guiding Catheter (6F MAC3.75, .070", Reference SA6MAC375), a cardiovascular device distributed worldwide to multiple countries. The recall was issued because some of these catheters may lose primary segment material, which could expose underlying stainless-steel braid wires.
The affected product is identified by GTIN 00613994822048 and includes all lot and serial numbers. The recall document does not specify a remedy or corrective 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: 9 units Lot/code info: GTIN: 00613994822048 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.