The Recall Desk
HighFDA (Devices)·Z-0053-2022·Announced 2021-10-13

ZOLL QUATTRO Intravascular Catheter Kit Labeling Update for Potential Leaks

ZOLL Circulation is updating labeling for its QUATTRO Intravascular Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The update affects 1,733 units distributed worldwide.

What this means for you

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 for a potential hazard (leaks from the catheter or tubing) where no illnesses or injuries have been reported. The score of 3 reflects the serious potential of a high-risk intravascular device while recognizing this addresses a theoretical risk without reported incidents.

Plain-English summary

ZOLL Circulation, Inc. is updating the labeling for the QUATTRO Intravascular Heat Exchange Catheter Kit (Model 8700-0783-03, all lot numbers) to alert users to potential leaks from the catheter or start-up kit (SUK) tubing. This is an FDA Class II medical device recall involving 1,733 units.

The update was issued to inform users of the potential leak hazard associated with these devices.

The affected product has been distributed worldwide, including to all 50 U.S. states and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.

Healthcare facilities and providers with affected units should review the updated labeling from ZOLL Circulation and follow any instructions provided regarding this hazard.

The recalled product

Product
Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Cardiovascular catheter
Hazard
Affected units
1,733

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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