Recall Z-0217-2015 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle. Left Ventricular Vent Cathe
| Date | Nov 14, 2014 (initiated Oct 8, 2014) |
| Status | Terminated |
| Reason | Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet. |
| Root cause | Device Design |
| Action | Edward Lifesciences sent an Urgent Medical Device Safety Notice date October 8, 2014, via Fed-Ex to all affected customers. On 3/4/15, letters were sent to surgeons. As part of the customer instructions in the safely notice, customers were requested to forward copies of the safely alert to any organization where the potentially affected devices have been transferred. No product is being returned. The distribution of the device has not been stopped as a result of this field correction. No additional production lots will be released for distribution until the IFU has been revised. Customers w |
| Quantity | 157,305 |
| Distribution | Worldwide Distribution - USA including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampsh |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113411 | EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA Edwards Lifesciences, LLC, Jun 11, 2012 |