SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0, .070", REF SA6MAC40. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 26 units of the Sherpa NX Active Guiding Catheter, 6F MAC4.0 model (reference SA6MAC40), a medical device used in cardiovascular procedures. The recall affects units distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, and others. The problem involves a potential defect where extensive loss of primary segment material can occur on a subset of these catheters, which would expose underlying stainless-steel braid wires.
The recall affects all lot and serial numbers of this product model, identified by GTIN 00613994822024. The source document does not specify what remedy or corrective action affected consumers should take.
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: 26 units Lot/code info: GTIN: 00613994822024 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.