SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5, .070", REF SA6JR35. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 1,495 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5, .070" (Reference SA6JR35) used for cardiovascular procedures. The recalled catheters have a potential defect where the outer material may deteriorate extensively on some units, which could expose the underlying stainless-steel braid wires inside the device. The affected catheters were distributed worldwide to medical facilities in 25 countries and regions, including the United States, various European nations, Hong Kong, Saudi Arabia, South Africa, Taiwan, and others. All lot and serial numbers of this product are included in the recall.
The recall notice does not specify what actions affected consumers or healthcare 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: 1495 units Lot/code info: GTIN: 00613994822390 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.