Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0050-2022·Announced 2021-10-13

Zoll ICY Heat Exchange Catheter Kit Labeling Update Due to Potential Leaks

ZOLL Circulation is updating labeling for its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 1,256 units 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class II recall involves a labeling update addressing potential device defects. No illnesses or injuries have been reported, and the precautionary nature of the labeling update supports a Moderate severity classification.

Plain-English summary

ZOLL Circulation, Inc. is updating the labeling for its ICY Intravascular Heat Exchange Catheter Kit (REF: 8700-0782-14, IC-3893CO) due to potential leaks that may occur in the catheter itself or in the start-up kit tubing. The catheter is a three-lumen, heparin-coated device designed for central venous infusion and intravascular heat exchange therapy. A total of 1,256 units have been affected by this labeling update.

The catheter kits were distributed worldwide, including throughout the United States and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. All lots of the affected product are included in this recall.

Healthcare providers and facilities using this device should review the updated labeling information regarding potential leak risks and implement appropriate precautions during use. Patients or healthcare providers with questions or concerns should contact ZOLL Circulation, Inc. directly.

The recalled product

Product: Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527
Manufacturer: ZOLL Circulation, Inc.
Category: Medical Device — Therapeutic / Heat Exchange Catheter
Hazard: potential-leak
device-defect
Affected units: 1,256

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 →

Same manufacturer · ZOLL Circulation, Inc.

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