SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU30. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 2,607 units of the Sherpa NX Active Guiding Catheter, 6F EBU3.5, .070" model worldwide. The recall affects units distributed to the United States and 24 other countries. The issue involves a potential for extensive loss of primary segment material that could expose underlying stainless-steel braid wires on a subset of these 6F Sherpa catheters.
The recall notice does not specify a remedy or required 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: 2607 units Lot/code info: GTIN: 00613994823625 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.