SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. 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 ERAD Left SH model (.070", Reference SA6ERADLSH), a device used in cardiovascular procedures. The recall affects a subset of 6F Sherpa catheters that may experience extensive loss of the primary segment material, which could expose the underlying stainless-steel braid wires. A total of 6 units have been affected by this issue.
The recalled catheters were distributed worldwide to 26 countries including the United States, various European nations, Hong Kong, Saudi Arabia, South Africa, and Taiwan. All lot and serial numbers of this model are included in the recall. The recall notice does not specify a remedy or instructions for 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: 6 units Lot/code info: GTIN: 00613994824738 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.