SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 1,701 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070" (reference number SA6AR20) due to a potential defect affecting a subset of these devices. The hazard involves extensive loss of the primary segment material, which could expose underlying stainless-steel braid wires. The affected catheters were distributed worldwide to hospitals and medical facilities in the United States and 24 other countries.
The recall involves all lot and serial numbers of this product with GTIN 00613994823892. The source document does not specify a remedy or corrective action for affected consumers to take.
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: 1701 units Lot/code info: GTIN: 00613994823892 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.