ZOLL COOL LINE Catheter Kit recalled for potential tubing leaks
ZOLL has recalled its COOL LINE Intravascular Heat Exchange Catheter Kit due to potential leaks in catheter and tubing components, affecting approximately 6,395 units distributed worldwide.
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 recall of a critical medical device with a theoretical hazard (potential leaks in intravascular catheter components). Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3). No illnesses or injuries are mentioned in the source.
Plain-English summary
ZOLL Circulation, Inc. is recalling the COOL LINE Intravascular Heat Exchange Catheter Kit (REF 8700-0781-40, UDI 00849111075213). This sterile, heparin-coated medical device is designed for intravascular temperature control with central venous infusion capabilities and three lumens.
The recall was initiated due to a labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing.
Approximately 6,395 units were affected under all lot numbers. Distribution was worldwide, including throughout the United States and to countries including Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.
The recalled product
- Product
- ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213
- Manufacturer
- ZOLL Circulation, Inc.
- Hazard
- Affected units
- 6,395
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 SOLEX 7(Heparin) IVTM Kit Recall: Potential Catheter and Tubing Leaks
FDA (Devices) · 2021-10-13
- HighZoll Intravascular Catheter Kit Labeling Update for Potential Leaks
FDA (Devices) · 2021-10-13
- HighZOLL Quattro IV therapy kit recalled due to potential catheter tubing leaks
FDA (Devices) · 2021-10-13
Same hazard · leak
See all →- SevereFresenius Medical Care Recalls 5008X Standard HD Pre-Flush Blood Tubing Sets
FDA (Devices) · 2026-09-09
- 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
Similar recalls
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- HighGore Balloon Catheter Leakage Recall Affects 3,364 Units Worldwide
FDA (Devices) · 2021-09-01
- HighBelmont Straight Inflow/Outflow Patient Line Kit recalled for potential connector crack
FDA (Devices) · 2025-05-07
- HighICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems
FDA (Devices) · 2019-01-02
- HighICU Medical Recalls I.V. Infusion Sets with Potential Leak
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls Thermoset Room Temperature Injectate Delivery Systems
FDA (Devices) · 2019-01-02