The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0051-2022·Announced 2021-10-13

Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Labeling Update for Leak Risk

ZOLL is issuing a labeling update for the QUATTRO Intravascular Heat Exchange Catheter Kit (188 units) addressing potential leaks from the catheter or start-up kit tubing.

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 Class II medical device recall involves a risk-of-harm product—potential leaks in an intravascular catheter could affect critical infusion therapy—but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

ZOLL Circulation, Inc. is issuing a labeling update for the QUATTRO Intravascular Heat Exchange Catheter Kit (REF 8700-0783-14, IC-4593CO). This is a 3-lumen, heparin-coated sterile medical device used for intravascular heat exchange with central venous infusion capabilities. Approximately 188 units across all lots have been distributed.

The labeling update addresses a potential risk of leaks from the catheter or start-up kit (SUK) tubing. No illnesses or injuries have been reported in relation to this concern.

The affected product has been distributed worldwide, including throughout the United States and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.

The recalled product

Product
Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075534
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Infusion Equipment
Hazard
Affected units
188

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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