Skip to content

ViperWireRecalls & reported problems across all models

Cardiovascular Systems, Inc. · 2 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
214
Deaths reported
10
Injuries reported
195
Recalls
0

We found 2 models of ViperWire by Cardiovascular Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 214 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2015 and Sep 24, 2026 — classified as 10 deaths, 195 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (183 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 3 reportsOct 2024: 3 reportsNov 2024: 1 reportsDec 2024: 2 reportsJan 2025: 6 reportsFeb 2025: 4 reportsMar 2025: 5 reportsApr 2025: 4 reportsMay 2025: 7 reportsJun 2025: 2 reportsJul 2025: 3 reportsAug 2025: 4 reportsSep 2025: 1 reportsOct 2025: 4 reportsNov 2025: 3 reportsDec 2025: 2 reportsJan 2026: 1 reportsFeb 2026: 2 reportsMar 2026: 3 reportsApr 2026: 2 reportsMay 2026: 1 reportsJun 2026: 1 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported ViperWire problems

Device problems

  • Material Separation183
  • Device Damaged by Another Device24
  • Adverse Event Without Identified Device or Use Problem15
  • Entrapment of Device14
  • Unintended System Motion12
  • Detachment of Device or Device Component9
  • Improper or Incorrect Procedure or Method8
  • Difficult to Advance5

Patient problems

  • Foreign Body In Patient145
  • Device Embedded In Tissue or Plaque34
  • Perforation of Vessels23
  • No Clinical Signs, Symptoms or Conditions17
  • Vascular Dissection8
  • Cardiac Arrest6
  • Embolism/Embolus5
  • Low Blood Pressure/ Hypotension5

ViperWire models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent ViperWire adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Cardiovascular Systems, Inc. products

All Cardiovascular Systems, Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page