SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. 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, AL3.0 110CM.070" (Reference SA6AL30A), a device used in cardiovascular procedures. The recall affects one unit that was distributed worldwide to multiple countries including the United States, various European nations, Hong Kong, Saudi Arabia, South Africa, and Taiwan.
The device is being recalled because there is a potential for extensive loss of primary segment material that could expose underlying stainless-steel braid wires. The affected product has GTIN 00613994824028, and all lot and serial numbers are included in the recall. The source document does not specify what actions affected consumers should take in response to this recall.
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: 1 unit Lot/code info: GTIN: 00613994824028 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.