BEUDAMED
    FDA Recall Open, Classified

    EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303

    Recall: Z-1320-2021 · Initiated February 22, 2021

    Recall

    Recall Number
    Z-1320-2021
    Event Number
    87412
    Firm
    EPIX THERAPEUTICS, INC
    FEI Number
    3015180993
    Product Code
    OAE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 22, 2021
    Address
    945 Stewart Dr, Ste 100, Sunnyvale, CA, 94085-3940

    Description

    EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303

    Reason

    It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.

    Action

    On February 22, 2021, Medtronic issued a "Urgent Medical Device Correction" notification via regionally approved methods to consignees who have received affected product. In addition to informing consignees about the recall the firm asked consignees to take the following actions: 1. Review the corrected language applicable to IFU and label as provided in the Appendix below. Until the IFU is updated with the corrected information, the information provided in the Appendix should be used in combination with the existing labeling provided with the DiamondTemp" Catheters. 2. Please share this information with healthcare professionals in your facility that use DiamondTemp" Catheters. Also share this information with any other organization where these devices may have been transferred. 3. Please maintain a copy of this notice in your records. We are committed to patient safety and welcome any questions you may have regarding this communication. Please contact your Medtronic representative with questions.

    Distribution

    Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada

    Quantity

    18 units