SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 12 units of Sherpa NX Active Guiding Catheter, 6F model (reference SA6AL10A), used in cardiovascular procedures. The catheters have a potential defect where the outer material may extensively wear away, exposing the underlying stainless-steel braid wires beneath. This affected product was distributed worldwide to multiple countries including the United States, Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom.
The recall notice does not specify a remedy or recommended action for affected consumers or patients.
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: 12 units Lot/code info: GTIN: 00613994823779 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.