SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0 SH, .070", REF SA6AL20SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 152 units of the Sherpa NX Active Guiding Catheter, 6F AL2.0 SH, .070" (Reference SA6AL20SH) due to a potential defect affecting a subset of these devices. The problem involves possible extensive loss of the primary segment material, which could expose the underlying stainless-steel braid wires. The affected catheters were distributed worldwide, including to the United States and multiple countries across Europe, Asia, the Middle East, and Africa.
The source document does not specify a remedy or instructions for what affected consumers 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: 152 units Lot/code info: GTIN: 00613994823717 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.