SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 90CM, 070", REF SA6JR40D. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 5 units of the Sherpa NX Active Guiding Catheter, 6F, JR4.0, 90CM model (Reference SA6JR40D) used in cardiovascular procedures. The catheters pose a potential hazard where the outer material may deteriorate extensively, exposing the underlying stainless-steel braid wires underneath. The affected devices were distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, and others.
The recall notice does not specify a remedy or what actions affected 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: 5 units Lot/code info: GTIN: 00613994822307 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.