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

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.