2026 data FDA MAUDE openFDA FDA Class II

Clamp, Vascular

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 §870.4450 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Clamp, Vascular MID-BOOK · MAUDE

#188 of 1000 · 12,982 reports · 1994–2026

  • BOOK 12,982 reports
  • RANK #188 of 1000
  • DEATH 78 death-typed
  • INJ 1,388 injury-typed
  • MALF 11,424 malfunction
  • SPAN 1994–2026
  • PEAK 2003: 1,220
  • PHOTO Pulse-Generator

Nearest event-volume peer: Pulse-Generator, Pacemaker, External (32 report gap)

Clamp, Vascular sits #188 of 1000 among tracked device types with 12,982 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 run above the device-type norm

Clamp, Vascular carries 88.0% MALFUNCTION-coded reports, 23.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 10.7% corpus 30.3% · below corpus mean (-19.6 pp)
  • MALF 88.0% corpus 64.8% · above corpus mean (+23.2 pp)

Lead product-problem code Replace is 18% of coded problems · Lead manufacturer GUIDANT CARDIAC SURGERY accounts for 32% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Clamp, Vascular in the event-volume neighbourhood

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

reports

What this shows Clamp, Vascular carries 12,982 MAUDE reports, ranked #188 of 1000.

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

Event Types

Malfunction 11,424 (88.0%)
Injury 1,388 (10.7%)
Death 78 (0.6%)
Other 57 (0.4%)
35 (0.3%)

Patient Outcomes

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

11,263 (85.2%)
Required Intervention 875 (6.6%)
Other 584 (4.4%)
R 151 (1.1%)
Hospitalization 89 (0.7%)
Death 77 (0.6%)
O 59 (0.4%)
Life Threatening 44 (0.3%)
L 23 (0.2%)
H 22 (0.2%)
S 10 (0.1%)
Disability 10 (0.1%)
D 4 (0.0%)
Congenital Anomaly 4 (0.0%)

Top Product Problems

Replace 2,474
Crack 2,293
Positioning Failure 1,795
Fitting Problem 1,401
Device Operates Differently Than Expected 1,078
Gas/Air Leak 704
Unraveled Material 444
Activation Problem 421
Sticking 378
Deflation Problem 358
Unintended Deflation 320
Break 307
Failure to Advance 284
Device Difficult to Setup or Prepare 276
Adverse Event Without Identified Device or Use Problem 227
Failure to Unfold or Unwrap 223
Difficult to Remove 216
Activation, Positioning or Separation Problem 191
Detachment Of Device Component 165
Air Leak 157

Yearly Trend

94
1994: 2
95
1995: 5
96
1996: 26
97
1997: 42
98
1998: 31
99
1999: 26
00
2000: 17
01
2001: 32
02
2002: 45
03
2003: 1,220
04
2004: 672
05
2005: 972
06
2006: 297
07
2007: 298
08
2008: 302
09
2009: 539
10
2010: 600
11
2011: 691
12
2012: 548
13
2013: 920
14
2014: 494
15
2015: 374
16
2016: 494
17
2017: 416
18
2018: 391
19
2019: 393
20
2020: 404
21
2021: 371
22
2022: 273
23
2023: 674
24
2024: 375
25
2025: 449
26
2026: 589

Reports in 2025 (449) held close to the prior two-year average of 525.

Related Entities for Clamp, Vascular

Event Locations

5,770 (44.4%)
HOSPITAL 3,980 (30.7%)
I 2,372 (18.3%)
OTHER 657 (5.1%)
NO INFORMATION 107 (0.8%)
NOT APPLICABLE 55 (0.4%)
UNKNOWN 22 (0.2%)
INVALID DATA 13 (0.1%)
HOME 4 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare GUIDANT CARDIAC SURGERY vs MAQUET CARDIOVASCULAR, LLC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Clamp, Vascular: 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 (12,982 here).

Similar death-typed counts

Nearest other device types by death-typed report count (78 here), distinct from the volume row.

Disclaimer: MAUDE figures for Clamp, Vascular 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 Clamp, Vascular; 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.