SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 658 units of the Sherpa NX Active Guiding Catheter, 6F, RDND1 55CM .070" (Reference SA6RDND1K) distributed worldwide across multiple countries. The recall was initiated due to a potential defect where extensive loss of the primary segment material could occur on a subset of these 6F Sherpa catheters, which would expose underlying stainless-steel braid wires that are normally covered.
The affected units include all lot and serial numbers of this product (GTIN 00643169013520). The source document does not specify a remedy or instructions for affected consumers 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: 658 units Lot/code info: GTIN 00643169013520 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.