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2026 data FDA MAUDE openFDA FDA Class II

Device, Percutaneous Retrieval

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 §870.5150 (Cardiovascular panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Device, Percutaneous Retrieval LIGHT-BOOK · MAUDE

#972 of 1000 · 398 reports · 1997–2026

  • BOOK 398 reports
  • RANK #972 of 1000
  • DEATH 7 death-typed
  • INJ 136 injury-typed
  • MALF 252 malfunction
  • SPAN 1997–2026
  • PEAK 2025: 49
  • PHOTO Probe

Nearest event-volume peer: Probe, Blood-Flow, Extravascular (0 report gap)

Device, Percutaneous Retrieval sits #972 of 1000 among tracked device types with 398 MAUDE reports spanning 1997–2026. 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 →

Injury-coded reports run above the device-type norm

Device, Percutaneous Retrieval carries 34.2% INJURY-coded reports, 3.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.8% corpus 1.5% · near corpus mean (+0.3 pp)
  • INJ 34.2% corpus 30.3% · above corpus mean (+3.9 pp)
  • MALF 63.3% corpus 64.8% · below corpus mean (-1.5 pp)

Lead product-problem code Break is 20% of coded problems · Lead manufacturer COOK INC accounts for 70% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Device, Percutaneous Retrieval in the event-volume neighbourhood

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

reports

What this shows Device, Percutaneous Retrieval carries 398 MAUDE reports, ranked #972 of 1000.

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

Event Types

Malfunction 252 (63.3%)
Injury 136 (34.2%)
Death 7 (1.8%)
Other 2 (0.5%)
1 (0.3%)

Patient Outcomes

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

185 (42.0%)
Required Intervention 118 (26.8%)
Other 53 (12.0%)
R 23 (5.2%)
Hospitalization 15 (3.4%)
Life Threatening 12 (2.7%)
L 11 (2.5%)
O 10 (2.3%)
Death 6 (1.4%)
H 3 (0.7%)
S 2 (0.5%)
D 1 (0.2%)
Disability 1 (0.2%)

Top Product Problems

Break 89
Material Separation 72
Fracture 44
Detachment Of Device Component 42
Detachment of Device or Device Component 41
Difficult to Remove 33
Adverse Event Without Identified Device or Use Problem 19
Entrapment of Device 11
Mechanical Problem 10
Deformation Due to Compressive Stress 9
Device Dislodged or Dislocated 9
Material Split, Cut or Torn 9
Improper or Incorrect Procedure or Method 8
Migration or Expulsion of Device 8
Material Fragmentation 7
Off-Label Use 7
Premature Separation 7
Connection Problem 6
Material Integrity Problem 6
Device Contaminated During Manufacture or Shipping 5

Yearly Trend

97
1997: 1
03
2003: 6
04
2004: 4
05
2005: 3
06
2006: 3
07
2007: 2
08
2008: 6
09
2009: 6
10
2010: 11
11
2011: 15
12
2012: 13
13
2013: 10
14
2014: 11
15
2015: 5
16
2016: 16
17
2017: 29
18
2018: 15
19
2019: 17
20
2020: 14
21
2021: 22
22
2022: 37
23
2023: 40
24
2024: 32
25
2025: 49
26
2026: 31

Reports in 2025 (49) held close to the prior two-year average of 36.

Related Entities for Device, Percutaneous Retrieval

Top Manufacturers

COOK INC 126
MERIT MEDICAL SYSTEMS, INC. 30
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 14
BARD PERIPHERAL VASCULAR, INC. 9

Event Locations

270 (67.8%)
I 94 (23.6%)
HOSPITAL 24 (6.0%)
NO INFORMATION 6 (1.5%)
OTHER 4 (1.0%)

Compare COOK INC vs MERIT MEDICAL SYSTEMS, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Device, Percutaneous Retrieval: 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 (398 here).

Probe, Blood-Flow, Extravascular 398 Bag 399 Diazo Colorimetry, Bilirubin 399 Device, Medical Examination, Ac Powered 401

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Dressing, Wound, Occlusive 7 Instrument 7 Joint, Temporomandibular, Implant 7 Mesh, Surgical, Absorbable, Abdominal Hernia 7

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

Disclaimer: MAUDE figures for Device, Percutaneous Retrieval 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 Device, Percutaneous Retrieval; 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.