ZOLL Circulation, Inc.

FDA Regulatory Profile

Summary

Total Recalls
33 (1 Class I)
510(k) Clearances
13
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1533-2025Class IBrand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog March 4, 2025
Z-0118-2023Class IIAutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct tSeptember 22, 2022
Z-0055-2022Class IIZoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit,August 6, 2021
Z-0043-2022Class IIZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central veAugust 6, 2021
Z-0060-2022Class IIZoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)August 6, 2021
Z-0062-2022Class IIZoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)August 6, 2021
Z-0039-2022Class IIZoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous August 6, 2021
Z-0054-2022Class IIZoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter August 6, 2021
Z-0065-2022Class IIZoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New LAugust 6, 2021
Z-0051-2022Class IIZoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central vAugust 6, 2021
Z-0042-2022Class IIZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter KiAugust 6, 2021
Z-0045-2022Class IIZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central August 6, 2021
Z-0058-2022Class IIZoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)August 6, 2021
Z-0053-2022Class IIZoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central vAugust 6, 2021
Z-0040-2022Class IIZoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter August 6, 2021
Z-0061-2022Class IIZoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)August 6, 2021
Z-0046-2022Class IIZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venousAugust 6, 2021
Z-0041-2022Class IIZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause CustAugust 6, 2021
Z-0066-2022Class IIZoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New LuAugust 6, 2021
Z-0049-2022Class IIZoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central veAugust 6, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemOctober 15, 2025
K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemNovember 3, 2023
K221700AutoPulse NXT Resuscitation SystemMarch 9, 2023
K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY InJanuary 13, 2023
K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY InJune 2, 2022
K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY InDecember 20, 2021
K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitMarch 24, 2016
K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange October 30, 2015
K141139SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETEROctober 3, 2014
K112998AUTOPULSE RESUSCITATION SYSTEM MODEL 1000March 15, 2012
K101987COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593October 12, 2010
K072527AUTOPULSE RESUSCITATION SYSTEM, MODEL 100March 19, 2008
K063602AUTOPULSE RESUSCITATION SYSTEM MODEL100December 21, 2006