The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0057-2022·Announced 2021-10-13

ZOLL ICY Intravascular Catheter Kit Recalled for Potential Catheter and Tubing Leaks

ZOLL Circulation is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The recall affects 58 kits distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm product (intravascular catheter with potential leak hazards), but the source text contains no reports of actual illnesses or injuries. Per the severity rubric, theoretical hazards without reported harm in medical devices rate as High (3).

Plain-English summary

ZOLL Circulation, Inc. is recalling the ZOLL REF 8700-0657-40 (IC-3893AE) ICY Intravascular Heat Exchange Catheter Kit, a medical device used for temperature management via an intravascular catheter with three-lumen central venous infusion capabilities. The recall was issued due to a labeling update concerning potential leaks from the catheter or start-up kit (SUK) tubing.

The affected product consists of 58 kits, all lot numbers included. The recalled device was distributed worldwide, including US distribution in 38 states (AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV) and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.

Healthcare providers using this device should be aware of the potential for catheter or tubing leaks, which could compromise proper device function during intravascular heat exchange therapy. The FDA notice provides no reports of related illnesses or injuries.

The recalled product

Product
Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravascular Catheter
Hazard
Affected units
58

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 28 recalled by ZOLL Circulation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 28 products in this recall →

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