BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2209-2009 · Initiated July 31, 2009

    Recall

    Recall Number
    Z-2209-2009
    Event Number
    52780
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    MNB
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 31, 2009
    Posted
    September 22, 2009
    Terminated
    May 3, 2011
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    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.

    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.

    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.

    Distribution

    Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.

    Quantity

    22,744 eaches