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Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

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FDA MAUDE adverse event data · 1994–2026

What the Data Shows About Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

The FDA MAUDE database aggregates 588 adverse-event reports for Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use spanning the period from 1994 through 2026. Of these, 5 are classified as death reports, 26 as injury reports, and 542 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 11 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Break topping the list at 47 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 33 years of MAUDE data, with the peak single-year volume reaching 130 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 8 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

588
Total Reports
5
Death Reports
26
Injury Reports
542
Malfunctions

Event Types

Malfunction 542 (92.2%)
Injury 26 (4.4%)
Other 10 (1.7%)
5 (0.9%)
Death 5 (0.9%)

Patient Outcomes

462 (77.3%)
Other 106 (17.7%)
R 7 (1.2%)
Hospitalization 5 (0.8%)
Required Intervention 5 (0.8%)
Disability 4 (0.7%)
Death 3 (0.5%)
L 2 (0.3%)
Life Threatening 2 (0.3%)
H 1 (0.2%)
O 1 (0.2%)

Top Product Problems

Break 47
Material Fragmentation 28
Thermal Decomposition of Device 26
Inadequate User Interface 12
Device Expiration Issue 11
Device Operates Differently Than Expected 10
Charred 7
Detachment of Device or Device Component 7
Defective Component 4
Failure to Align 4
Use of Device Problem 4
Difficult to Open or Close 3
Improper or Incorrect Procedure or Method 3
Smoking 3
Adverse Event Without Identified Device or Use Problem 2
Burst Container or Vessel 2
Device Slipped 2
Expiration Date Error 2
Insufficient Information 2
Unintended Electrical Shock 2

Yearly Trend

94
1994: 1
95
1995: 3
96
1996: 3
97
1997: 3
98
1998: 5
99
1999: 2
00
2000: 1
01
2001: 7
02
2002: 7
03
2003: 14
04
2004: 12
05
2005: 6
06
2006: 35
07
2007: 6
08
2008: 7
09
2009: 5
10
2010: 7
11
2011: 40
12
2012: 18
13
2013: 26
14
2014: 112
15
2015: 130
16
2016: 70
17
2017: 31
18
2018: 10
19
2019: 7
20
2020: 4
21
2021: 1
22
2022: 1
23
2023: 4
24
2024: 2
25
2025: 6
26
2026: 2

Related Entities for Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Event Locations

371 (63.1%)
I 160 (27.2%)
HOSPITAL 33 (5.6%)
NO INFORMATION 11 (1.9%)
OTHER 6 (1.0%)
UNKNOWN 3 (0.5%)
INVALID DATA 2 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.3%)

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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 device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.