SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL205. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 30 units of the Sherpa NX Active Guiding Catheter, 6F AL2.0 model (reference SA6AL205) used in cardiovascular procedures. The devices were distributed worldwide to 27 countries including the United States, Austria, Belgium, and others. The recall was initiated because certain units have a potential defect where the outer material coating may extensively wear away, which could expose the underlying stainless-steel braid wires.
The recall notice does not specify a remedy for affected consumers or what actions they 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: 30 units Lot/code info: GTIN: 20613994842248 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.