SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0, .070", REF SA6SAL20. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling the Sherpa NX Active Guiding Catheter, 6F SAL2.0, .070" (Reference SA6SAL20), a cardiovascular device distributed worldwide. The recall affects 20 units across multiple countries including the United States, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, and others. The recalled product is identified by GTIN 00613994823151 and includes all lot and serial numbers.
The recall was issued due to a potential defect where the primary segment material on a subset of these 6F Sherpa catheters could experience extensive loss, potentially exposing underlying stainless-steel braid wires. The recall record does not specify a remedy or instructions 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: 20 units Lot/code info: GTIN: 00613994823151 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.