SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0, .070", REF SA6RBU40. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 159 units of SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0, .070" (Reference SA6RBU40) used for cardiovascular procedures. The recalled catheters have a potential defect where the outer material may extensively break down, exposing underlying stainless-steel braid wires. The affected devices were distributed worldwide to numerous countries including the United States, Austria, Belgium, France, Germany, Italy, Spain, the United Kingdom, and others.
The recall affects all lot and serial numbers of this product, identified by GTIN 00613994822963. The source document does not specify what remedy or action an affected consumer 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: 159 units Lot/code info: GTIN: 00613994822963 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.