SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDC, 55CM, 070", REF SA6RDCK. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 49 units of the Sherpa NX Active Guiding Catheter, 6F, RDC, 55CM, 070" (REF SA6RDCK) due to a potential defect where the outer material layer may extensively deteriorate, exposing underlying stainless-steel braid wires. The affected catheters were distributed worldwide to multiple countries including the United States, Austria, Belgium, France, Germany, Italy, and others.
The recall notice does not specify what action affected consumers 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: 49 units Lot/code info: GTIN: 00613994823250 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.