Cardinal Health Cordis® POWERFLEX® PRO PTA Dilatation Catheter

Important Customer Notice Update

Ref: 2019/870 ICN Number: 870

MHRA 2019/008/028/291/001
NHSSC 48

Update

  • Previously, Cardinal Health had issued a Field Safety Notice (Removal) in October 2019 regarding its Cordis® POWERFLEX® PRO PTA Dilatation Catheter.
  • Cardinal Health was recently informed that an additional product has been identified as being affected by the same issue.
  • Cardinal Health has issued an additional Field Safety Notice to recall this specific product for one batch number only.

Products Affected:

  • There is one NHS Supply Chain product code affected via our eDirect route:
    NPC MPC Batch Number Product Name
    FRE4320 4206020S 82155955 Catheter Powerflex p3 f5 6×2 80


Next Steps:

  • Read and follow the full instructions in the Field Safety Notice (see our Downloads ▼ section) and share this document with all users of the affected products.
  • Cardinal Health assure us they are already in contact with all the impacted trusts, however if you need further assistance please call 0203 7995 9970,or contact your Cardinal Health representative.
  • If you have any of the affected lot numbers please also contact your NHS Customer Service Advisor with full details to enable us to monitor return direct to the supplier and manage your credit.

MHRA 2019/008/028/291/001
NHSSC 48

Alert:

  • Cardinal Health has issued a Field Safety Notice to recall specific lot numbers of its Cordis® POWERFLEX® PRO PTA Dilatation Catheter.
  • The specific lot numbers have not met Cardinal Health internal manufacturing specification for shaft burst strength.
  • A shaft leakage/burst that occurs during balloon inflation would likely create an inability to inflate or maintain pressure of the balloon component. The user may experience inflation difficulty/deflation difficulty of the balloon component.
  • There are no safety concerns for patients that are treated successfully using product from these lots.

Products Affected:

  • There are two NHS Supply Chain product codes affected via our eDirect route:
    NPC MPC Lot Number Supplier
    FRE5669 4400604S 82144604, 82144617 Balloon Catheter Percutaneous transluminal angioplasty over the wire powerflex pro – .035.
    FRE5697 4400804S 82144499 Balloon Catheter Percutaneous transluminal angioplasty over the wire powerflex pro – .035 8 x 40 80cm shaft.
  • Please refer to the Field Safety Notice and product listing below for further information on the affected product codes and potential alternatives.

Next Steps:

  • Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.
  • Cardinal assure us they are already in contact with all the impacted trusts, however if you need further assistance please call 0203 7995 9970 or contact your Cardinal representative.
  • If you have any of the affected lot numbers please also contact your NHS Customer Service Advisor with full details to enable us to monitor return direct to the supplier and manage your credit.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Downloads ▼

  • 870 Cardinal Health Field Safety Notice

    A PDF document detailing Cardinal Health Field Safety Notice for ICN 870.
  • 870 Cardinal Health Additional Product Field Safety Notice

    A PDF document detailing the field safety notice for the additional code for ICN 870.