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ZOLL Circulation, Inc.

United States·US-MF-000008550

Last updated September 17, 2026

Information

Country: United States
Address: 2000, Ringwood Avenue, San Jose, United States
Website: zoll.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Doug Lam
EUDAMED SRN: US-MF-000008550
FDA FEI Number: 3003793491
DUNS Number: —

Catalogue (381)

Page 8 of 8

Device	Model / Reference	Registries	Class	Status
Start-Up Kit Custom Luer	CG-500D	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
LifeBand® Load-distributing Band	100	FDA UDI	Class II	Active
AutoPulse Li-ion Battery™	100	FDA UDI	Class II	Active
Catheter Introducer Kit, 10.7f	NA	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse Battery	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse Multi-Chemistry Battery Charger	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
Quattro, Japan, Final Packaged Kit (Applause)	IC-4593	FDA UDI	Class II	Active
Thermogard XP, Lang set B, Rohs, Refurb	NA	FDA UDI	Class II	Active
QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin)	IC-4593	FDA UDI	Class II	Active
LifeBand® Load-distributing Band	Model 200	FDA UDI	Class II	Active
Autopulse Resuscitation System Model 1000	K112998	FDA 510(k)	Class II	Active
Autopulse Resuscitation System, Model 100	K072527	FDA 510(k)	Class II	Active
Cool Line Catheter, Model Cl-2295a, Icy Catheter, Model Ic-3893a And Quattro Catheter, Model Ic-4593	K101987	FDA 510(k)	Class II	Active
Autopulse Resuscitation System Model100	K063602	FDA 510(k)	Class II	Active
Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)	K250979	EUDAMEDFDA 510(k)	Class II	Active
Solex Intravascular Heat Exchange Catheter	K141139	FDA 510(k)	Class II	Active
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console	K220008	FDA 510(k)	Class II	Active
Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System	K231182	FDA 510(k)	Class II	Active
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console	K213031	FDA 510(k)	Class II	Active
AutoPulse NXT Resuscitation System	K221700	FDA 510(k)	Class II	Active
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console	K223746	FDA 510(k)	Class II	Active
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter	K150046	FDA 510(k)	Class II	Active
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit	K153226	FDA 510(k)	Class II	Active
TherOx Downstream Cartridge	P170027	FDA PMA	Class III	Active

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FDA Recalls (34)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 4, 2025	Z-1533-2025	—	open, classified	AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
Sep 22, 2022	Z-0118-2023	—	open, classified	Due to increase in Li-Ion Battery failures
Aug 6, 2021	Z-0042-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0045-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0058-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0066-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0053-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0044-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0049-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0061-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0047-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0055-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0054-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0065-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0046-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0052-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0040-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0048-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0063-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0059-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0064-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0060-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0051-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0039-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0056-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0062-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0043-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0050-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0057-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0041-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Apr 1, 2014	Z-0477-2015	—	terminated	After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed.
Jul 16, 2013	Z-2090-2014	—	terminated	Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product.
Aug 8, 2012	Z-0658-2013	—	terminated	Complaints associated with an unexpected stop in AutoPulse compressions.
Jan 28, 2008	Z-1904-2011	—	terminated	Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).