SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR405. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 615 units of its Sherpa NX Active Guiding Catheter (6F JR4.0, .070") distributed worldwide because a subset of these catheters may experience extensive loss of primary segment material, which could expose the underlying stainless-steel braid wires. The affected devices were distributed to multiple countries including the United States, various European nations, Hong Kong, Saudi Arabia, South Africa, and Taiwan.
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: 615 units Lot/code info: GTIN: 20613994822325 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.