Recall Z-0837-2009 ยท ITX Transducer, Ultrasonic, Diagnostic
Boston Scientific Corporation
Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
| Date | Jan 28, 2009 (initiated Oct 9, 2008) |
| Status | Terminated |
| Reason | Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year. |
| Root cause | Labeling mix-ups |
| Action | Recall initiated on October 6, 2008, and notification letters sent on October 8, 2008. Letters were sent via FedEx. Responses are being tracked along with delivery verification. For additional information contact Boston Scientific Corporation at 1-508-652-5594. |
| Quantity | 1033 units |
| Distribution | Worldwide Distribution --- USA including Puerto Rico and country of Panama |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080272 | ATLANTIS PVIMAGING CATHETER, MODEL H749364560 Boston Scientific Corp, Mar 11, 2008 |