2026 data FDA MAUDE openFDA FDA Class II

Shunt, Central Nervous System And Components

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 §882.5550 (Neurology panel).

FDA MAUDE casebook

openFDA event book Shunt, Central Nervous System And Components MID-BOOK · MAUDE

#123 of 1000 · 25,418 reports · 1992–2026

  • BOOK 25,418 reports
  • RANK #123 of 1000
  • DEATH 222 death-typed
  • INJ 16,249 injury-typed
  • MALF 7,925 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 1,484
  • PHOTO Mitral Valve Repair D…

Nearest event-volume peer: Mitral Valve Repair Devices (18 report gap)

Shunt, Central Nervous System And Components sits #123 of 1000 among tracked device types with 25,418 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 →

Malfunction reports sit below the device-type norm

Shunt, Central Nervous System And Components carries 31.2% MALFUNCTION-coded reports, 33.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.9% corpus 1.5% · below corpus mean (-0.6 pp)
  • INJ 63.9% corpus 30.3% · above corpus mean (+33.6 pp)
  • MALF 31.2% corpus 64.8% · below corpus mean (-33.6 pp)

Lead product-problem code Infusion or Flow Problem is 12% of coded problems · Lead manufacturer MEDTRONIC NEUROSURGERY accounts for 100% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Shunt, Central Nervous System And Components in the event-volume neighbourhood

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

reports

What this shows Shunt, Central Nervous System And Components carries 25,418 MAUDE reports, ranked #123 of 1000.

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

Event Types

Injury 16,249 (63.9%)
Malfunction 7,925 (31.2%)
613 (2.4%)
Other 409 (1.6%)
Death 222 (0.9%)

Patient Outcomes

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

Required Intervention 10,741 (38.0%)
10,181 (36.0%)
Hospitalization 2,724 (9.6%)
R 2,582 (9.1%)
Other 1,350 (4.8%)
Death 219 (0.8%)
H 112 (0.4%)
L 105 (0.4%)
O 76 (0.3%)
S 56 (0.2%)
Life Threatening 40 (0.1%)
Disability 37 (0.1%)
Congenital Anomaly 9 (0.0%)
D 7 (0.0%)
Invalid Data 3 (0.0%)

Top Product Problems

Infusion or Flow Problem 2,800
Explanted 2,695
Break 2,141
Other (for use when an appropriate device code cannot be identified) 1,524
Leak/Splash 1,486
Obstruction of Flow 1,461
Insufficient Device Problem Information 1,322
Mechanical Problem 1,309
Adverse Event Without Identified Device or Use Problem 1,244
Replace 1,081
Appropriate Device Problem Term/Code Not Available 1,075
Occlusion Within Device 998
Fluid/Blood Leak 768
Device Operates Differently Than Expected 688
Fracture 652
Program, failure to 613
Partial Blockage 612
Valve(s), failure of 539
Disconnection 519
Programming Issue 494

Yearly Trend

92
1992: 2
93
1993: 5
94
1994: 17
95
1995: 21
96
1996: 99
97
1997: 158
98
1998: 276
99
1999: 305
00
2000: 286
01
2001: 371
02
2002: 442
03
2003: 512
04
2004: 536
05
2005: 489
06
2006: 626
07
2007: 648
08
2008: 629
09
2009: 629
10
2010: 812
11
2011: 787
12
2012: 977
13
2013: 1,004
14
2014: 1,251
15
2015: 984
16
2016: 1,091
17
2017: 1,335
18
2018: 1,484
19
2019: 1,295
20
2020: 1,206
21
2021: 1,467
22
2022: 1,329
23
2023: 1,221
24
2024: 1,214
25
2025: 1,219
26
2026: 691

Reports in 2025 (1,219) held close to the prior two-year average of 1,218.

Related Entities for Shunt, Central Nervous System And Components

Top Manufacturers

Event Locations

14,301 (56.3%)
I 8,100 (31.9%)
HOSPITAL 2,718 (10.7%)
NO INFORMATION 168 (0.7%)
INVALID DATA 50 (0.2%)
OTHER 29 (0.1%)
HOME 24 (0.1%)
UNKNOWN 20 (0.1%)
NOT APPLICABLE 5 (0.0%)
NURSING HOME 1 (0.0%)
OPERATING ROOM 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Shunt, Central Nervous System And Components: 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 (25,418 here).

Similar death-typed counts

Nearest other device types by death-typed report count (222 here), distinct from the volume row.

Disclaimer: MAUDE figures for Shunt, Central Nervous System And Components 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 Shunt, Central Nervous System And Components; 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.