The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0048-2022·Announced 2021-10-13

Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Recall for Potential Leaks

Zoll Circulation recalls approximately 20,475 QUATTRO intravascular heat exchange catheter kits distributed worldwide due to 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 is a Class II medical device recall for a risk-of-harm product where potential leaks in an intravascular heat exchange catheter could compromise patient safety during clinical use. No illnesses or injuries have been reported, placing it at the maximum severity of 3 per the rubric.

Plain-English summary

Zoll Circulation, Inc. is recalling the QUATTRO Intravascular Heat Exchange Catheter Kit (model REF: 8700-0783-01, IC-4593) with Custom Luer Applause Heparin coating. Approximately 20,475 units have been distributed in 38 US states and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.

The recall addresses potential leaks that may occur from the catheter itself or the start-up kit (SUK) tubing. These leaks could compromise the function and safety of the heat exchange system during clinical use.

All lot numbers of this product are subject to the recall. Patients and healthcare providers using or in possession of this catheter kit should contact their healthcare provider or Zoll Circulation, Inc. immediately for guidance on returning or replacing affected units.

The recalled product

Product
Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravascular Catheter
Hazard
Affected units
20,475

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 →

Related recalls

Same manufacturer · ZOLL Circulation, Inc.

See all →

Same hazard · catheter leak

See all →

Similar recalls