2026 data FDA MAUDE openFDA FDA Class I

Battery, Replacement, Rechargeable

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4820 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Battery, Replacement, Rechargeable LIGHT-BOOK · MAUDE

#347 of 1000 · 4,301 reports · 2004–2026

  • BOOK 4,301 reports
  • RANK #347 of 1000
  • DEATH 0 death-typed
  • INJ 42 injury-typed
  • MALF 4,253 malfunction
  • SPAN 2004–2026
  • PEAK 2022: 860
  • PHOTO Pump

Nearest event-volume peer: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (54 report gap)

Battery, Replacement, Rechargeable sits #347 of 1000 among tracked device types with 4,301 MAUDE reports spanning 2004–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Battery, Replacement, Rechargeable carries 98.9% MALFUNCTION-coded reports, 34.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 1.0% corpus 30.3% · below corpus mean (-29.3 pp)
  • MALF 98.9% corpus 64.8% · above corpus mean (+34.1 pp)

Lead product-problem code Battery Problem is 23% of coded problems · Lead manufacturer DEPUY SYNTHES POWER TOOLS accounts for 34% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Battery, Replacement, Rechargeable in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Battery, Replacement, Rechargeable carries 4,301 MAUDE reports, ranked #347 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 4,253 (98.9%)
Injury 42 (1.0%)
Other 4 (0.1%)
2 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

4,188 (97.6%)
Other 68 (1.6%)
Required Intervention 24 (0.6%)
Death 5 (0.1%)
Hospitalization 4 (0.1%)
O 1 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Battery Problem 1,052
Unintended System Motion 492
Fail-Safe Problem 446
Device Inoperable 406
Device Operates Differently Than Expected 337
Failure to Charge 294
Break 273
Overheating of Device 151
Charging Problem 146
Fracture 145
Complete Loss of Power 134
Mechanical Problem 104
Leak/Splash 88
Failure to Power Up 74
Noise, Audible 72
Appropriate Device Problem Term/Code Not Available 68
Difficult to Open or Close 66
Defective Component 55
Crack 54
Device Displays Incorrect Message 53

Yearly Trend

04
2004: 2
05
2005: 3
06
2006: 4
07
2007: 2
08
2008: 8
09
2009: 1
10
2010: 4
11
2011: 3
12
2012: 3
13
2013: 202
14
2014: 526
15
2015: 769
16
2016: 364
17
2017: 507
18
2018: 133
19
2019: 78
20
2020: 120
21
2021: 123
22
2022: 860
23
2023: 125
24
2024: 184
25
2025: 196
26
2026: 84

Reports in 2025 (196) held close to the prior two-year average of 155.

Related Entities for Battery, Replacement, Rechargeable

Event Locations

2,490 (57.9%)
I 1,764 (41.0%)
HOSPITAL 21 (0.5%)
NO INFORMATION 17 (0.4%)
OTHER 8 (0.2%)
NURSING HOME 1 (0.0%)

Compare DEPUY SYNTHES POWER TOOLS vs ZOLL CIRCULATION →

Nationwide devices with a comparable report-volume footprint

Battery, Replacement, Rechargeable carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (4,301 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Battery, Replacement, Rechargeable are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Battery, Replacement, Rechargeable; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.