SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5 SH, .070", REF SA6SCR35SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 14 units of the Sherpa NX Active Guiding Catheter, 6F SCR3.5 SH model (.070"), used in cardiovascular procedures. The catheters have a potential defect where extensive loss of primary segment material could expose underlying stainless-steel braid wires. This affects all lot and serial numbers of this product (GTIN: 00613994822604).
The affected catheters were distributed worldwide to hospitals and medical facilities in the US and numerous other countries including Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom, among others. The source document does not specify what action affected consumers should take regarding 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: 14 units Lot/code info: GTIN: 00613994822604 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.