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2026 data FDA MAUDE openFDA

Biopsy Needle

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

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FDA MAUDE casebook

openFDA event book Biopsy Needle LIGHT-BOOK · MAUDE

#329 of 1000 · 4,597 reports · 1992–2026

  • BOOK 4,597 reports
  • RANK #329 of 1000
  • DEATH 26 death-typed
  • INJ 971 injury-typed
  • MALF 3,579 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 641
  • PHOTO Cement

Nearest event-volume peer: Cement, Bone, Vertebroplasty (42 report gap)

Biopsy Needle sits #329 of 1000 among tracked device types with 4,597 MAUDE reports spanning 1992–2026. 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 0.6% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 21.1% corpus 30.4% · below corpus mean (-9.3 pp)
  • MALF 77.9% corpus 64.5% · above corpus mean (+13.3 pp)

Lead product-problem code Break is 28% of coded problems · Lead manufacturer COOK IRELAND LTD accounts for 45% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Biopsy Needle in the event-volume neighbourhood

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

reports

What this shows Biopsy Needle carries 4,597 MAUDE reports, ranked #329 of 1000.

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

Event Types

Malfunction 3,579 (77.9%)
Injury 971 (21.1%)
Death 26 (0.6%)
13 (0.3%)
Other 8 (0.2%)

Patient Outcomes

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

3,517 (73.8%)
Required Intervention 643 (13.5%)
Other 292 (6.1%)
R 106 (2.2%)
Hospitalization 100 (2.1%)
O 32 (0.7%)
Death 23 (0.5%)
H 20 (0.4%)
Life Threatening 11 (0.2%)
L 10 (0.2%)
D 6 (0.1%)
S 3 (0.1%)
Disability 1 (0.0%)

Top Product Problems

Break 1,010
Fracture 370
Material Twisted/Bent 352
Adverse Event Without Identified Device or Use Problem 235
Retraction Problem 206
Improper or Incorrect Procedure or Method 205
Off-Label Use 165
Detachment of Device or Device Component 156
Device Contamination with Chemical or Other Material 112
Physical Resistance/Sticking 109
Bent 90
Difficult to Remove 87
Occlusion Within Device 86
Material Separation 74
Material Perforation 71
Kinked 67
Material Deformation 53
Mechanical Problem 46
Use of Device Problem 46
Failure to Advance 44

Yearly Trend

92
1992: 1
93
1993: 1
99
1999: 6
00
2000: 8
01
2001: 6
02
2002: 6
03
2003: 13
04
2004: 7
05
2005: 10
06
2006: 18
07
2007: 11
08
2008: 115
09
2009: 270
10
2010: 73
11
2011: 71
12
2012: 107
13
2013: 130
14
2014: 154
15
2015: 124
16
2016: 191
17
2017: 273
18
2018: 282
19
2019: 229
20
2020: 240
21
2021: 290
22
2022: 302
23
2023: 428
24
2024: 446
25
2025: 641
26
2026: 144

Related Entities for Biopsy Needle

Top Manufacturers

COOK IRELAND LTD 1,698
BARD PERIPHERAL VASCULAR, INC. 681
AOMORI OLYMPUS CO., LTD. 490
BOSTON SCIENTIFIC - SPENCER 273
OLYMPUS MEDICAL SYSTEMS CORP. 249
BOSTON SCIENTIFIC CORPORATION 166
CAREFUSION 84
GYRUS ACMI, INC. 77
COOK ENDOSCOPY 71

Event Locations

2,033 (44.2%)
HOSPITAL 1,929 (42.0%)
I 561 (12.2%)
NO INFORMATION 49 (1.1%)
OUTPATIENT DIAGNOSTIC FACILITY 7 (0.2%)
OUTPATIENT TREATMENT FACILITY 7 (0.2%)
OTHER 6 (0.1%)
HOME 3 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)

Compare COOK IRELAND LTD vs BARD PERIPHERAL VASCULAR, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Biopsy Needle, 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 (4,597 here).

Cement, Bone, Vertebroplasty 4,555 Apparatus 4,648 Table, Obstetrical, Ac-Powered 4,662 Lavage, Jet 4,670

Similar death-typed counts

Nearest other device types by death-typed report count (26 here), distinct from the volume row.

Catheter 26 Catheter, Irrigation 26 Pump 26 Stimulator 26

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

Disclaimer: MAUDE figures for Biopsy Needle 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 Biopsy Needle; 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.