SHERPA NX ACTIVE GUIDING CATHETER, 6F, JCR4.0, 100CM, 070", REF SA6JCR40. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 27 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F, JCR4.0, 100CM, 070" (REF SA6JCR40) used in cardiovascular procedures. The devices have a potential defect where the outer material may break down extensively on a subset of these catheters, which could expose the underlying stainless-steel braid wires. The affected product applies to all lot and serial numbers with GTIN 00613994824288, and the devices were distributed worldwide to numerous countries including the US, multiple European nations, and several others.
The recall notice does not specify a remedy or corrective action that consumers should 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: 27 units Lot/code info: GTIN: 00613994824288 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.