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AcusnareRecalls & reported problems across all models

Cook Incorporated · 14 models in the FDA device registry

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

Adverse event reports
272
Deaths reported
0
Injuries reported
23
Recalls
0

We found 14 models of Acusnare by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 272 adverse event reports in the FDA's MAUDE database, received between May 13, 2016 and Sep 29, 2026 — classified as 23 injuries, 249 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (70 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: 2 reportsDec 2023: 3 reportsJan 2024: 6 reportsFeb 2024: 0 reportsMar 2024: 5 reportsApr 2024: 8 reportsMay 2024: 3 reportsJun 2024: 2 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 3 reportsOct 2024: 3 reportsNov 2024: 1 reportsDec 2024: 1 reportsJan 2025: 5 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 2 reportsMay 2025: 3 reportsJun 2025: 1 reportsJul 2025: 2 reportsAug 2025: 4 reportsSep 2025: 1 reportsOct 2025: 2 reportsNov 2025: 4 reportsDec 2025: 7 reportsJan 2026: 3 reportsFeb 2026: 2 reportsMar 2026: 1 reportsApr 2026: 3 reportsMay 2026: 3 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 3 reportsSep 2026: 3 reportsOct 2026: 0 reports2024202520268
Last 36 months. The most recent month may be incomplete.

Most reported Acusnare problems

Device problems

  • Retraction Problem70
  • Failure to Conduct68
  • Failure to Cut50
  • Off-Label Use36
  • Difficult to Open or Close19
  • Material Twisted/Bent15
  • Material Separation11
  • Deformation Due to Compressive Stress8

Patient problems

  • No Clinical Signs, Symptoms or Conditions124
  • No Consequences Or Impact To Patient113
  • Hemostasis7
  • No Patient Involvement6
  • Device Embedded In Tissue or Plaque5
  • Foreign Body In Patient5
  • Gastrointestinal Hemorrhage5
  • Perforation5

Acusnare models

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

Recent Acusnare adverse event reports

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

Other Cook Incorporated products

All Cook Incorporated devices →

Sources and updates

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