BEUDAMED
    FDA Recall Terminated

    CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

    Recall: Z-1513-2015 · Initiated March 25, 2015

    Recall

    Recall Number
    Z-1513-2015
    Event Number
    70851
    FEI Number
    3010140265
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 25, 2015
    Posted
    April 23, 2015
    Terminated
    August 21, 2015
    Address
    CSA Medical 91 Hartwell Ave, Lexington, MA, 02421-3137

    Description

    CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

    Reason

    TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax

    Action

    CSA Medical issued letter dated 3/25/15 advising users of the problem. Users provided with: The mitigations available to the active venting procedures coupled with the extremely unlikely probability of injury, rare risk, thus allowing the physician to continue with active venting procedures. In regards a passive venting procedure may not have sufficient mitigation to allow the physician to identify the potential hazard with sufficient time to preclude a potential for injury. Therefore, passive users will be instructed not to use the system until a software improvement is put into place. Additionally, no catheters or consoles will be shipped to passive venting users of truFreeze. A response form to be signed and returned confirming receipt of the notification.Questions contact: Stephen Mascioli, MD 781-538-4755 [email protected].

    Distribution

    Nationwide

    Quantity

    82 units