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.
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 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.
- 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
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.
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