SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0 SH, .070", REF SA6EBU40SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 303 units of the Sherpa NX Active Guiding Catheter, 6F EBU4.0 SH model (.070") used in cardiovascular procedures. The devices may experience extensive loss of the outer material layer, which could expose underlying stainless-steel braid wires. This recall affects units distributed worldwide to patients and healthcare facilities across multiple countries including the United States, various European nations, Hong Kong, Saudi Arabia, South Africa, and Taiwan.
The record does not specify what consumers or healthcare providers should do regarding 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: 303 units Lot/code info: GTIN: 00613994823496 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.