SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling Sherpa NX Active Guiding Catheters, model 6F EBU3.5 110CM.070" (reference SA6EBU35A), used in cardiovascular procedures. A subset of these catheters may experience extensive loss of the outer protective material, which could expose the underlying stainless-steel braid wires. Eighteen units of this product were distributed worldwide to 25 countries including the United States, various European nations, and Asia.
The recall affects all lot and serial numbers of this device model. The source 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: 18 units Lot/code info: GTIN: 00613994823588 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.