SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0 SH, .070", REF SA6AL30SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 33 units of the Sherpa NX Active Guiding Catheter (6F AL3.0 SH, .070") worldwide due to a potential defect affecting a subset of these devices. The catheters may experience extensive loss of the primary segment material, which could expose the underlying stainless-steel braid wires. These devices were distributed to customers in the United States and 24 other countries.
The recall affects all lot and serial numbers of this product, identified by GTIN 00613994824011. The source document does not specify a remedy or recommended action for affected consumers.
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: 33 units Lot/code info: GTIN: 00613994824011 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.