ZOLL CIRCULATION

FDA MAUDE device safety record · 2006–2025

What the Data Shows About ZOLL CIRCULATION

ZOLL CIRCULATION is associated with 10,465 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2006 through 2025. Of the total, 43 are coded as death reports and 215 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 10 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ZOLL CIRCULATION should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 10,197 reports (97.4% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 20 years of MAUDE data, with the peak single-year volume reaching 1,643 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

10,465
Total Reports
43
Death Reports
215
Injury Reports
10
Device Types

Event Types

Malfunction 10,197 (97.4%)
Injury 215 (2.1%)
Death 43 (0.4%)
Other 8 (0.1%)
2 (0.0%)

Patient Outcomes

10,035 (95.5%)
Other 275 (2.6%)
Death 63 (0.6%)
O 30 (0.3%)
Required Intervention 29 (0.3%)
Hospitalization 20 (0.2%)
R 18 (0.2%)
Life Threatening 18 (0.2%)
Congenital Anomaly 12 (0.1%)
Disability 8 (0.1%)
D 3 (0.0%)
H 1 (0.0%)

Yearly Trend

06
2006: 5
07
2007: 1
08
2008: 6
09
2009: 2
10
2010: 6
11
2011: 7
12
2012: 23
13
2013: 49
14
2014: 195
15
2015: 688
16
2016: 886
17
2017: 1,099
18
2018: 1,145
19
2019: 991
20
2020: 1,281
21
2021: 1,175
22
2022: 1,643
23
2023: 872
24
2024: 387
25
2025: 4

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.