Z-2209-2009

Boston Scientific HydroThermAblator Endometrial Ablation System- HTA System Procedure Set with Tenaculum...

Name: Z-2209-2009 Boston Scientific HydroThermAblator Endometrial Ablation System- HTA System Procedure Set with Tenaculum...
Creator: Boston Scientific Corporation
Published: 2009-07-31
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-07-31 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific HydroThermAblator Endometrial Ablation System- HTA System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (5/bx)... on 2009-07-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2209-2009
Status: Terminated
Initiated: 2009-07-31
Posted: 2009-09-22
Terminated: 2011-05-03
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific HydroThermAblator Endometrial Ablation System- HTA System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (5/bx) Material/UPN/Catalog Number: M006560201 System-HTA System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (ea) Material/UPN/Catalog Number: M006560200 Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.
Product code: MNB Device, Thermal Ablation, Endometrial
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 22,744 eaches
Distribution: Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.
Product codes and lots: Lot Numbers: 35421, 35422, 35423, 35424, 35425, 35426, 35846, 35847, 35890, 35891, 35892, 36038, 36039, 36040, 36041, 36042, 36047, 36048, 36104, 36105, 36141, 36142, 36143, 36146, 36147, 36148, 36214, 36215, 36234,36235, 36249, 36250, 36251, 36260, 36261 ,36370, 36371, 36372, 36467, 36468, 36682, 36683, 36684, 36685, 36686, 36688, 36689, 36690, 36693, 36694, 36695, 37049, 37098, 37099, 37149, 37150, 37151, 37154, 37192, 37218, 37219, 37220, 37221, 37222, 3and 7223.

Product code MNB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)