Zoll Circulation Intravascular Heat Exchange Catheters Updated Instructions For Use (ICN 1410)

Important Customer Notice Field Safety Notice

Ref: 2021/1410 ICN Number: 1410

MHRA 2021/009/028/579/003
NHSSC Ref: 51

Alert:

  • Following a Review of adverse events reported to the FDA between January 1 2019 and August 8 2021, Zoll Circulation is voluntarily conducting a field safety corrective action (FSCA) on the product labelling for all Intravascular Heat Exchange Catheters.
  • The adverse events reported identified over 200 medical device reports (MDRs) that reported catheter balloon leaks associated with all ZOLL Intravascular Heat Exchange Catheters.
  • See the urgent Field Safety Notice in our Downloads ▼ section for further details of these reports and potential consequences.

Products Affected:

  • Two of the products affected are available from NHS Supply Chain as:
NPC Product Description Supplier Code/ MPC Supply Route
VCB340 Intravenous Cooling Icy Catheter Kit IC-3893AE Blue Diamond
VCB341 Intravenous Cooline Catheter Kit CL-2295AE Blue Diamond

Next Steps:

The revised Instructions For Use now includes:

  • Detailed step-by-step instructions on how to investigate/confirm potential leaks from either the catheter or the SUK.
  •  Multiple warning/caution/adverse reaction statements instructing users to avoid replacing depleted saline bags prior to identifying the location of the leak and taking the appropriate mitigation steps.
  •  The detailed leak investigation instructions, warnings, cautions, and adverse reactions associated with leaks from either the catheter or the SUK, on page 3.

Actions required:

  • Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
  • Complete and return the Customer acknowledgment Form, found on page 4, to IVTM_Recall@zoll.com as soon as possible.
  •  If you have any further questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanatavi (VP of Quality and Regulatory Affairs) via IVTM_Recall@zoll.com.

Downloads ▼

  • 1410 Zoll Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1410.