SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB, .070", REF SA6RCB. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 248 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB, .070" (Reference SA6RCB) used in cardiovascular procedures. The catheters have a potential defect where the outer coating material may extensively wear away, exposing underlying stainless-steel braid wires. The affected catheters were distributed worldwide to medical facilities in multiple countries including the United States, Canada, and various European nations.
The recall affects all lot and serial numbers of this product (GTIN: 00613994822918). The source record does not specify what action affected consumers or facilities 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: 248 units Lot/code info: GTIN: 00613994822918 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.