SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0, .070", REF SA6JL60. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 136 units of the Sherpa NX Active Guiding Catheter, 6F JL6.0, .070" (reference SA6JL60) due to a potential defect where the outer material may extensively wear away, exposing the underlying stainless-steel braid wires beneath. The affected catheters were distributed worldwide to medical facilities in the United States and 24 other countries.
The recall notice does not specify what actions 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: 136 units Lot/code info: GTIN: 00613994822437 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.