BEUDAMED
    FDA Recall Terminated

    The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath. The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistulas. The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires) that rotates at 3000 rpm when rotator is activated. The current device is 7 Fr in size and comes in two lengths -- 65 cm and 120 cm. This device is used by inserting the catheter into the occluded graft or fistula via introducer sheath and then activating the rotator unit.

    Recall: Z-0842-05 · Initiated March 18, 2005

    Recall

    Recall Number
    Z-0842-05
    Event Number
    31765
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 18, 2005
    Posted
    May 13, 2005
    Terminated
    November 22, 2006
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath. The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistulas. The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires) that rotates at 3000 rpm when rotator is activated. The current device is 7 Fr in size and comes in two lengths -- 65 cm and 120 cm. This device is used by inserting the catheter into the occluded graft or fistula via introducer sheath and then activating the rotator unit.

    Reason

    The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use.

    Action

    The firm began notification of consignees on 3/23/2005 via certified letter.

    Distribution

    Product was distributed nationwide to dealers, hospitals, sales representatives, and subsidiaries (distributors). The product was also distributed to Australia, Canada, Colombia, Czech Republic, France, Germany, Israel, Italy, Japan, Netherlands, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom. There are no government accounts.

    Quantity

    2418 UNITS