SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 614 units of the Sherpa NX Active Guiding Catheter, model 6F EBU3.5 SH, .070" (reference number SA6EBU35SH), a device used in cardiovascular procedures. The recalled catheters have a potential defect where the outer material layer may extensively deteriorate, which could expose the underlying stainless-steel wire braid underneath. These affected units were distributed worldwide to medical facilities in multiple countries including the United States, Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, the United Kingdom, and numerous others.
The product identification for affected catheters is GTIN 00613994823564, and all lot and serial numbers of this model are included in the recall. However, the recall record does not specify what action affected consumers or healthcare providers 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: 614 units Lot/code info: GTIN: 00613994823564 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.