FDA Medical Device Recalls (openFDA)
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 is complete.
- Recall number
- Z-2208-2009
- Recalling firm
- Boston Scientific Corporation
- Product
- 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 is complete.
- Status
- Terminated
- Initiated
- 2009-07-31
- Posted
- 2009-09-22
- Terminated
- 2011-05-03
- 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 box and store it on the inventory shelf by the inner package only. If this is a practice at the facility, a customer must consider both the inner and outer packaging product codes when searching for affected recalled product as the UPN numbers on the inner and outer labeling are different. A reply verification tracking form for customers was provided in case they have located any additional product to return.
- Quantity
- 1,555 eaches
- Distribution
- Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.
- Lot, serial or model codes
- Lot Numbers: 35773, 35854, 35855, 36070, 36071, 36072, 36073, 36259, 36462, 36463, 36852, 37046, 37047, 37432, and 37433.
- 510(k) numbers
- not on file
- PMA numbers
- ["P000040"]
- Product code
- MNB
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28