SHERPA NX ACTIVE GUIDING CATHETER, 6F, MP1, 55CM, 070", REF SA6MP1K. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling Sherpa NX Active Guiding Catheters (6F, MP1, 55CM, 070", REF SA6MP1K) used in cardiovascular procedures. The catheters have a potential defect where the outer material may extensively wear away, exposing the underlying stainless-steel braided wires beneath.
The affected catheters were distributed worldwide to hospitals and medical facilities in the United States and 24 other countries. The recall covers all lot and serial numbers of this product. The source document does not specify what actions affected consumers should take in response to 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: 0 units Lot/code info: GTIN: 00613994821881 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.