SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 219 units of SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070" (Reference SA6AL30) that were distributed worldwide to 25 countries including the United States, Austria, Belgium, France, Germany, Italy, Spain, and others. The catheters are used in cardiovascular procedures. The recall was initiated because a subset of these 6F Sherpa catheters have a potential defect where the outer material may extensively deteriorate, which could expose underlying stainless-steel braid wires.
The record does not specify a remedy or any actions that 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: 219 units Lot/code info: GTIN: 00613994823687 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.