| Product Name/Description |
LEO+ Self-Expanding Nitinol Stent (Stent, vascular, intracranial) and Eclipse Balloon Catheter (Catheter, intravascular, occluding)
Product Codes:LEO55X50, LEO45X40, LEO45X40, LEO55X75, LEO40X30, LEO45X30, LEO45X25, LEO40X35, LEO45X25, LEO45X30, SECLIPSE7
Lots: 633957, 638339,639251, 639961, 643012, 643348, 645061, 646869, 648969, 649236 |
| Reason for the Action |
Routine bacterial endotoxin quality control testing performed by the manufacturer, Balt Extrusion SAS (France), returned non-conforming results on sampled ANRYV connectors.
Two production lots of the ANRYV connector did not meet the established endotoxin acceptance criteria. As testing is performed on a sampling basis, the presence of non-conforming devices within the affected lots cannot be excluded.
Elevated endotoxin levels in a device that contacts the bloodstream may cause a pyrogenic reaction (e.g. fever or inflammatory response) in the patient. No patient injuries related to this problem have been reported.
The LEO+ stent and Eclipse balloon catheter devices themselves are not affected by this problem; however, as the connector lot cannot be identified without opening the packaging, the complete units are being recalled. |