SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.5, .070", REF SA6SL35. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 2,818 units of the Sherpa NX Active Guiding Catheter, 6F SL3.5, .070" (Reference SA6SL35) due to a potential defect in a subset of these devices. The issue involves extensive loss of primary segment material that could expose underlying stainless-steel braid wires. The affected devices were distributed worldwide, including to the United States and 23 other countries in Europe, Asia, Africa, and the Middle East.
The product identification for consumers is GTIN 00613994822529, and all lot and serial numbers are included in this recall. However, the recall record 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: 2818 units Lot/code info: GTIN: 00613994822529 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.