SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 12 units of Sherpa NX Active Guiding Catheters (6F, AL.75 110CM.070", REF SA6AL75A) used in cardiovascular procedures. The catheters have a potential defect where the outer material may extensively wear away, which could expose the underlying stainless-steel braid wires inside the device. This defect affects all lot and serial numbers of this product.
The affected catheters were distributed worldwide to hospitals and medical facilities in the United States and 24 other countries. The recall notice does not specify any remedy or corrective action for 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: 12 units Lot/code info: GTIN: 00613994823960 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.