SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, 110CM, .070" REF SA6JR40SHA. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular has recalled one SHERPA NX ACTIVE GUIDING CATHETER (model 6F JR4.0 SH, 110CM, .070") used in cardiovascular procedures. The catheter has a potential defect where the outer material layer may extensively break down, which could expose the underlying stainless-steel braid wires beneath. This affected product was distributed worldwide to numerous countries including the United States, various European nations, and parts of Asia.
The recall involves one unit with GTIN 00613994821843 and includes all lot and serial numbers for this product. The source document does not specify what remedy or corrective action 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: 1 unit Lot/code info: GTIN: 00613994821843 All Lot Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.