The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0049-2022·Announced 2021-10-13

Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Recalled for Potential Tubing Leaks

ZOLL Circulation is recalling 13,935 QUATTRO Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or start-up kit tubing. The affected devices were distributed worldwide, including across all US states.

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 potential leaks in an intravascular catheter used in critical care settings. No illnesses or injuries have been reported, meeting the criteria for High severity: a risk-of-harm product where injury has not yet been documented.

Plain-English summary

ZOLL Circulation, Inc. is recalling the QUATTRO Intravascular Heat Exchange Catheter Kit (REF 8700-0783-40, model IC-4593AE) due to potential leaks that may occur in the catheter or the start-up kit (SUK) tubing. The recall affects all manufacturing lots of this device.

The affected catheter kits were distributed worldwide, including across all US states and to international locations including Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. A total of 13,935 units are involved in this recall.

Healthcare providers and patients who have or use this catheter kit should consult with their healthcare provider for guidance on next steps and any alternative treatment options. Patients should not discontinue use of the device without consulting their healthcare provider. Facilities should contact ZOLL Circulation for return instructions and replacement units if needed.

The recalled product

Product
Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravascular Catheter
Hazard
Affected units
13,935

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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