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Zoll Circulation

FDA adverse event reports naming Zoll Circulation as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ZOLL CIRCULATION.

Total reports
10,470
Deaths
43
Injuries
219
Malfunctions
10,198

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

Recent recalls

  • 2025-04-11Open, ClassifiedProcess change control

    Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A

    AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.

  • 2022-10-21Open, ClassifiedDevice Design

    AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR

    Due to increase in Li-Ion Battery failures

  • 2014-12-03TerminatedOther

    7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.

    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.

  • 2014-07-22TerminatedLabeling Change Control

    Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.

    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.

  • 2013-01-09TerminatedEmployee error

    AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

    Complaints associated with an unexpected stop in AutoPulse compressions.

  • 2011-04-07TerminatedOther

    Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.

    Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).

  • TerminatedLabeling design

    Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237

    Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

  • TerminatedLabeling design

    Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3

    Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

  • TerminatedLabeling design

    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

    Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

  • TerminatedLabeling design

    ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:

    Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

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