SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.5, .070:, REF SA6AL25. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling the SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.5, .070" (Reference SA6AL25), a cardiovascular device used in medical procedures. The recall affects 6 units that were distributed worldwide to 25 countries including the United States, various European nations, Hong Kong, Saudi Arabia, South Africa, and Taiwan. The problem is that a subset of these 6-French catheters may lose extensive amounts of the primary segment material, which could expose the underlying stainless-steel braid wires beneath.
The source document does not specify a remedy or recommended course of 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: 6 units Lot/code info: GTIN: 00613994823700 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.