SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 20 units of the Sherpa NX Active Guiding Catheter, 6F model (reference number SA6NOTO, 100cm, 070"), a device used in cardiovascular procedures. The catheters have a potential defect where the outer material layer may extensively deteriorate, exposing the underlying stainless-steel braid wires beneath. The affected product was distributed worldwide to multiple countries including the United States, European nations, Hong Kong, Saudi Arabia, South Africa, and Taiwan.
The recall notice does not specify a remedy for affected consumers or indicate what actions they should take regarding this recalled device.
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: 20 units Lot/code info: GTIN: 00613994823021 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.