2026 data FDA MAUDE openFDA FDA Class II

Ring, Annuloplasty

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 II (moderate risk, special controls required), regulated under 21 CFR §870.3800 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Ring, Annuloplasty LIGHT-BOOK · MAUDE

#221 of 1000 · 9,673 reports · 1994–2026

  • BOOK 9,673 reports
  • RANK #221 of 1000
  • DEATH 780 death-typed
  • INJ 8,517 injury-typed
  • MALF 206 malfunction
  • SPAN 1994–2026
  • PEAK 2008: 1,288
  • PHOTO Driver, Prosthesis

Nearest event-volume peer: Driver, Prosthesis (9 report gap)

Ring, Annuloplasty sits #221 of 1000 among tracked device types with 9,673 MAUDE reports spanning 1994–2026. 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 sit below the device-type norm

Ring, Annuloplasty carries 2.1% MALFUNCTION-coded reports, 62.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 8.1% corpus 1.5% · above corpus mean (+6.6 pp)
  • INJ 88.0% corpus 30.3% · above corpus mean (+57.8 pp)
  • MALF 2.1% corpus 64.8% · below corpus mean (-62.7 pp)

Lead product-problem code Unknown (for use when the device problem is not known) is 29% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 57% of manufacturer-tagged reports · Top event location HOSPITAL is 51% of location-tagged rows .

Ring, Annuloplasty in the event-volume neighbourhood

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

reports

What this shows Ring, Annuloplasty carries 9,673 MAUDE reports, ranked #221 of 1000.

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

Event Types

Injury 8,517 (88.0%)
Death 780 (8.1%)
Malfunction 206 (2.1%)
Other 148 (1.5%)
22 (0.2%)

Patient Outcomes

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

Required Intervention 7,188 (59.9%)
R 1,368 (11.4%)
Hospitalization 1,204 (10.0%)
Death 784 (6.5%)
H 608 (5.1%)
L 328 (2.7%)
235 (2.0%)
Life Threatening 178 (1.5%)
Other 50 (0.4%)
S 18 (0.2%)
O 17 (0.1%)
D 8 (0.1%)
Congenital Anomaly 8 (0.1%)
Disability 2 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Unknown (for use when the device problem is not known) 3,077
Insufficient Device Problem Information 2,450
Explanted 1,621
Adverse Event Without Identified Device or Use Problem 1,340
Patient Device Interaction Problem 381
Replace 357
Intravalvular regurgitation 244
Inadequacy of Device Shape and/or Size 223
Appropriate Device Problem Term/Code Not Available 173
Perivalvular Leak 126
Deterioration of prosthesis 119
Valve(s), failure of 112
Other (for use when an appropriate device code cannot be identified) 89
Reflux within Device 77
Device Operates Differently Than Expected 69
Material Separation 61
Incomplete Coaptation 58
Lack of Effect 52
Leak/Splash 52
Gradient Increase 51

Yearly Trend

94
1994: 2
96
1996: 47
97
1997: 105
98
1998: 130
99
1999: 174
00
2000: 191
01
2001: 195
02
2002: 154
03
2003: 84
04
2004: 124
05
2005: 295
06
2006: 286
07
2007: 261
08
2008: 1,288
09
2009: 973
10
2010: 630
11
2011: 321
12
2012: 90
13
2013: 97
14
2014: 73
15
2015: 145
16
2016: 347
17
2017: 379
18
2018: 378
19
2019: 349
20
2020: 340
21
2021: 423
22
2022: 372
23
2023: 324
24
2024: 407
25
2025: 425
26
2026: 264

Reports in 2025 (425) held close to the prior two-year average of 366.

Related Entities for Ring, Annuloplasty

Event Locations

HOSPITAL 4,890 (50.6%)
2,361 (24.4%)
I 2,255 (23.3%)
OTHER 135 (1.4%)
OPERATING ROOM 10 (0.1%)
NO INFORMATION 6 (0.1%)
HOME 5 (0.1%)
INVALID DATA 5 (0.1%)
UNKNOWN 5 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare EDWARDS LIFESCIENCES vs MEDTRONIC HEART VALVES DIVISION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ring, Annuloplasty: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (9,673 here).

Similar death-typed counts

Nearest other device types by death-typed report count (780 here), distinct from the volume row.

Disclaimer: MAUDE figures for Ring, Annuloplasty 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 Ring, Annuloplasty; 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.