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InstinctRecalls & reported problems across all models

Cook Incorporated · 5 models in the FDA device registry

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

1 open recall names at least one Instinct model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
1,289
Deaths reported
0
Injuries reported
48
Recalls
1

We found 5 models of Instinct by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 1,289 adverse event reports in the FDA's MAUDE database, received between Feb 19, 2016 and Sep 30, 2026 — classified as 48 injuries, 1,241 malfunctions.

The most frequently reported specific device problem is “Material Separation” (529 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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: 9 reportsDec 2023: 7 reportsJan 2024: 9 reportsFeb 2024: 2 reportsMar 2024: 13 reportsApr 2024: 11 reportsMay 2024: 20 reportsJun 2024: 14 reportsJul 2024: 15 reportsAug 2024: 23 reportsSep 2024: 38 reportsOct 2024: 36 reportsNov 2024: 33 reportsDec 2024: 16 reportsJan 2025: 35 reportsFeb 2025: 37 reportsMar 2025: 30 reportsApr 2025: 23 reportsMay 2025: 29 reportsJun 2025: 20 reportsJul 2025: 30 reportsAug 2025: 22 reportsSep 2025: 18 reportsOct 2025: 8 reportsNov 2025: 19 reportsDec 2025: 17 reportsJan 2026: 5 reportsFeb 2026: 10 reportsMar 2026: 17 reportsApr 2026: 15 reportsMay 2026: 9 reportsJun 2026: 8 reportsJul 2026: 2 reportsAug 2026: 11 reportsSep 2026: 34 reportsOct 2026: 0 reports20242025202638
Last 36 months. The most recent month may be incomplete.

Instinct recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Mar 3, 2026Open, Classified

    Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.

    Z-1812-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported Instinct problems

Device problems

  • Material Separation529
  • Difficult to Open or Close511
  • Premature Separation276
  • Failure to Fire272
  • Separation Failure234
  • Premature Activation124
  • Improper or Incorrect Procedure or Method91
  • Difficult or Delayed Separation42

Patient problems

  • No Clinical Signs, Symptoms or Conditions1,033
  • No Consequences Or Impact To Patient155
  • Foreign Body In Patient85
  • Gastrointestinal Hemorrhage38
  • No Patient Involvement16
  • Tissue Damage13
  • Hemostasis11
  • No Known Impact Or Consequence To Patient11

Instinct models

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

Recent Instinct 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