SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. 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, JL3.5, 110CM, 070" (Reference SA6JL35A), 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 underlying stainless-steel braid wires. A total of 12 units with all lot and serial numbers (identified by GTIN 00613994822222) were distributed worldwide to countries including the United States, various European nations, Hong Kong, Saudi Arabia, South Africa, and Taiwan.
The source document does not specify what action affected consumers or healthcare providers 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: 12 units Lot/code info: GTIN: 00613994822222 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.