SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070", REF SA6MAC35. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 185 units of its Sherpa NX Active Guiding Catheter (6F MAC 3.5, .070") used in cardiovascular procedures worldwide. The recalled catheters have a potential defect where the outer material coating may wear away extensively, which could expose the underlying stainless-steel braid wires inside the device.
The affected catheters were distributed to hospitals and medical facilities across the United States and 24 other countries. The source document does not specify what actions affected consumers should take in response to 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: 185 units Lot/code info: GTIN: 00613994821768 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.