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2026 data FDA MAUDE openFDA

Instruments, Surgical, Cardiovascular

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.

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FDA MAUDE casebook

openFDA event book Instruments, Surgical, Cardiovascular LIGHT-BOOK · MAUDE

#706 of 1000 · 820 reports · 1996–2026

  • BOOK 820 reports
  • RANK #706 of 1000
  • DEATH 10 death-typed
  • INJ 168 injury-typed
  • MALF 617 malfunction
  • SPAN 1996–2026
  • PEAK 2018: 60
  • PHOTO Forceps, Ophthalmic

Nearest event-volume peer: Forceps, Ophthalmic (3 report gap)

Instruments, Surgical, Cardiovascular sits #706 of 1000 among tracked device types with 820 MAUDE reports spanning 1996–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 20.5% corpus 30.4% · below corpus mean (-10.0 pp)
  • MALF 75.2% corpus 64.5% · above corpus mean (+10.7 pp)

Lead product-problem code Break is 25% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 64% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Instruments, Surgical, Cardiovascular in the event-volume neighbourhood

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

reports

What this shows Instruments, Surgical, Cardiovascular carries 820 MAUDE reports, ranked #706 of 1000.

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

Event Types

Malfunction 617 (75.2%)
Injury 168 (20.5%)
Other 20 (2.4%)
Death 10 (1.2%)
5 (0.6%)

Patient Outcomes

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

505 (59.7%)
Required Intervention 159 (18.8%)
Other 119 (14.1%)
R 16 (1.9%)
Life Threatening 14 (1.7%)
Hospitalization 12 (1.4%)
Death 10 (1.2%)
L 6 (0.7%)
O 3 (0.4%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Break 79
Mechanical Jam 40
Corroded 23
Failure to Cut 16
Mechanical Problem 16
Adverse Event Without Identified Device or Use Problem 15
Detachment of Device or Device Component 15
Physical Resistance/Sticking 15
Difficult to Open or Close 13
Misfire 11
Material Separation 9
Insufficient Information 8
Delivered as Unsterile Product 7
Entrapment of Device 7
Fracture 7
Material Fragmentation 7
Contamination /Decontamination Problem 6
Device Operates Differently Than Expected 6
Difficult to Remove 6
Material Integrity Problem 6

Yearly Trend

96
1996: 7
97
1997: 8
98
1998: 17
99
1999: 20
00
2000: 16
01
2001: 28
02
2002: 17
03
2003: 11
04
2004: 15
05
2005: 14
06
2006: 32
07
2007: 20
08
2008: 15
09
2009: 44
10
2010: 27
11
2011: 55
12
2012: 33
13
2013: 34
14
2014: 43
15
2015: 26
16
2016: 33
17
2017: 40
18
2018: 60
19
2019: 28
20
2020: 28
21
2021: 32
22
2022: 35
23
2023: 18
24
2024: 48
25
2025: 12
26
2026: 4

Related Entities for Instruments, Surgical, Cardiovascular

Top Manufacturers

TELEFLEX MEDICAL 179
MAQUET CARDIOVASCULAR, LLC 60
MAQUET CARDIOVASCULAR LLC 42

Event Locations

392 (47.8%)
I 209 (25.5%)
HOSPITAL 181 (22.1%)
OTHER 19 (2.3%)
UNKNOWN 8 (1.0%)
NO INFORMATION 7 (0.9%)
INVALID DATA 3 (0.4%)
NOT APPLICABLE 1 (0.1%)

Compare TELEFLEX MEDICAL vs MAQUET CARDIOVASCULAR, LLC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Instruments, Surgical, Cardiovascular, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (820 here).

Forceps, Ophthalmic 823 Plate 816 Suture, Nonabsorbable, Synthetic, Polyester 824 Hammer, Surgical 827

Similar death-typed counts

Nearest other device types by death-typed report count (10 here), distinct from the volume row.

Accessories, Catheter 10 Adaptor, Hygiene 10 Cabinet, Table And Tray, Anesthesia 10 Chair, Adjustable, Mechanical 10

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Instruments, Surgical, Cardiovascular 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 Instruments, Surgical, Cardiovascular; 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.