SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB, 90CM, 070", REF SA6RCBD. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular has recalled one unit of the SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB, 90CM, 070" (reference number SA6RCBD), a device used in cardiovascular procedures. The catheter was distributed worldwide to multiple countries including the United States, various European nations, and several Asian and Middle Eastern countries. The recall was issued due to a potential defect where the outer material coating could deteriorate extensively, which would expose the underlying stainless-steel braid wires of the device.
The recall applies to all lot and serial numbers of this specific product model. The source document does not specify a remedy or recommended course of action for consumers or healthcare providers who may have received this 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: 1 unit Lot/code info: GTIN: 00613994822901 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.