Recall Z-1396-05 ยท DYB Introducer, Catheter
Guidant Cardiac Surgery
Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
| Date | Aug 24, 2005 (initiated Jul 5, 2005) |
| Status | Terminated |
| Reason | Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. Use of the cutter on altered tissue has caused the aortic plug to not be captured by the device |
| Root cause | Other |
| Action | Notification to customers sent via FedEx on July 5, 2005, with product handling instruction sheet. Follow up communications to non-returning consignees will be recorded and documented. |
| Quantity | 7391 units |
| Distribution | Product was distributed to 274 consignees. 15 are international distributors. 259 hospitals. The product is fully distributed to the following countries: USA, Belgium, CAnada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Israel, Italy, Lebanon, Netherlands, Poland, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.