ZOLL COOL LINE Intravascular Catheter Kit recalled for potential tubing leaks
ZOLL Circulation is recalling 4,812 COOL LINE Intravascular Heat Exchange Catheter Kits worldwide due to potential leaks in the catheter or startup 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: FDA Class II intravascular catheter with potential leak defect. Meets rubric criterion for risk-of-harm product where injury has not yet been reported. No hospitalization reports, so score is limited to 3.
Plain-English summary
ZOLL Circulation, Inc. is recalling the ZOLL COOL LINE Intravascular Heat Exchange Catheter Kit (Model 8700-0781-01 / CL-2295) due to potential leaks from the catheter or the startup kit (SUK) tubing.
The recall affects 4,812 kits distributed worldwide to healthcare facilities in all US states and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.
As an FDA Class II recall, this issue has been identified through a labeling review. Further information and specific instructions regarding the recalled units should be obtained from ZOLL Circulation, Inc.
The recalled product
- Product
- ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- Affected units
- 4,812
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.
See all 28 products in this recall →Related recalls
Same manufacturer · ZOLL Circulation, Inc.
See all →- CriticalAutoPulse NXT Resuscitation System may fail to provide chest compressions
FDA (Devices) · 2025-04-23
- HighAutoPulse Resuscitation System Battery Recalled for Increased Li-ion Failures
FDA (Devices) · 2022-11-02
- HighZoll Intravascular Catheter Kit Labeling Update for Potential Leaks
FDA (Devices) · 2021-10-13
- HighZoll ICY IV Disposable Pack Recall: Potential Catheter and Tubing Leaks
FDA (Devices) · 2021-10-13
- HighZoll COOLINE Intravascular Catheter Kit recalled for potential leak hazard
FDA (Devices) · 2021-10-13
Same hazard · leak
See all →- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighAnti-siphon smallbore extension sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05