SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0, .070", REF SA6JR50. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular has recalled 339 units of SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0, .070" (REF SA6JR50) due to a potential defect where the outer material may extensively deteriorate and expose underlying stainless-steel braid wires. This cardiovascular device was distributed worldwide to 25 countries including the United States, European nations, and parts of Asia and the Middle East. The recalled product applies to all lot and serial numbers with GTIN 00613994821805.
The recall record does not specify what actions affected consumers or healthcare facilities 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: 339 units Lot/code info: GTIN: 00613994821805 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.