Recall Z-2208-2009 ยท MNB Device, Thermal Ablation, Endometrial
Boston Scientific Corporation
Boston Scientific HydroThermAblator Endometrial Ablation System- HTA Procedure Set (5/bx) Material/UPN/Catalog Number: M006550161 Boston Scientific HydroThermAblator Endometrial Ablation System-HTA Procedure Set (ea) Material/UPN/Catalog Number: M006550160 Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing
| Date | Sep 22, 2009 (initiated Jul 31, 2009) |
| Status | Terminated |
| Reason | Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns. |
| Root cause | Process design |
| Action | Boston Scientific issued an Urgent Medical Device Recall - Immediate Action Required notification to hospitals and distributors dated July 31, 2009 via Federal Express and requested the immediate discontinued use and segregation of Recall product for return and Complete and return the Reply Verification Tracking Form. An email was sent to Physicians to provide the recall information. Boston Scientific issued a Clarification letter dated August 6, 2009 via Federal Express as a follow-up to the July 31, 2009 Recall letter for the following reason: customers may remove product from the outer bo |
| Quantity | 1,555 eaches |
| Distribution | Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.