SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5, .070", REF SA6AL15. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 208 units of Sherpa NX Active Guiding Catheter (6F AL1.5, .070") used in cardiovascular procedures worldwide. The recalled devices have a potential defect where the outer material may extensively wear away, exposing the underlying stainless-steel braid wires beneath.
The recall affects all lot and serial numbers of this product (GTIN: 00613994842381) distributed to the United States and 24 other countries. The source document does not specify a remedy or what affected consumers should do.
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: 208 units Lot/code info: GTIN: 00613994842381 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.