SaeedRecalls & reported problems across all models
Cook Incorporated · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 863
- Deaths reported
- 2
- Injuries reported
- 73
- Recalls
- 0
We found 15 models of Saeed by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 863 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2016 and Sep 25, 2026 — classified as 2 deaths, 73 injuries, 788 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (266 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
Most reported Saeed problems
Device problems
- Failure to Fire266
- Premature Activation220
- Device Dislodged or Dislocated111
- Material Too Soft/Flexible52
- Material Separation49
- Detachment of Device or Device Component44
- Premature Separation38
- Positioning Failure35
Patient problems
- No Clinical Signs, Symptoms or Conditions471
- No Consequences Or Impact To Patient250
- Foreign Body In Patient112
- No Patient Involvement76
- Gastrointestinal Hemorrhage25
- Hemorrhage/Blood Loss/Bleeding20
- No Known Impact Or Consequence To Patient9
- Hemostasis8
Saeed models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Saeed G22692Ligator, esophageal295 reports
- Saeed G22553Ligator, esophageal289 reports
- Saeed G31917Ligator, esophageal123 reports
- Saeed G24654Ligator, esophageal50 reports
- Saeed G31919Ligator, esophageal28 reports
- Saeed G26861Ligator, esophageal19 reports
- Saeed G25221Ligator, esophageal12 reports
- Saeed G22613Ligator, esophageal9 reports
- Saeed G22614Ligator, esophageal2 deaths9 reports
- Saeed G24748Ligator, esophageal6 reports
- Saeed G31918Ligator, esophageal6 reports
- Saeed G25424Ligator, esophageal5 reports
- Saeed G25119Ligator, esophageal4 reports
- Saeed G25240Ligator, esophageal4 reports
- Saeed G31915Ligator, esophageal4 reports
Recent Saeed adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Premature Activation
During preparation for an endoscopic variceal ligation in the esophagus, the physician selected a Cook 6 Shooter Saeed Multi-Band Ligator.It was reported that the user opened the package and discovered that the bands had premature released. The user changed to another device to complete the procedure.This occurred prior to patient contact; there was no impact to the patient. In addition, the patient sustained no clinical consequence and there were no adverse effects to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898341 ↗MalfunctionSep 25, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898053 ↗MalfunctionSep 25, 2026Failure to Fire
During an endoscopic variceal ligation in the esophagus, the physician used a Cook 6 Shooter Saeed Multi-Band Ligator. It was reported that after assembling the ligature, the ligator is moved to the target area for ligation treatment. The ligator could not be released normally by the fourth band, The endoscope was then removed and replaced with a new device to complete the procedure.Other than the deployed bands, a section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897830 ↗MalfunctionSep 24, 2026Premature Activation
Patient problems: Foreign Body In Patient
MAUDE report 50891193 ↗MalfunctionSep 24, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882776 ↗MalfunctionSep 24, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882698 ↗MalfunctionSep 21, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843193 ↗MalfunctionSep 16, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791464 ↗MalfunctionSep 14, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763328 ↗MalfunctionSep 14, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763004 ↗MalfunctionSep 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762646 ↗MalfunctionSep 10, 2026Device Dislodged or Dislocated; Material Too Soft/Flexible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718168 ↗MalfunctionSep 2, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565485 ↗MalfunctionSep 1, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547218 ↗MalfunctionAug 31, 2026Device Handling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50530968 ↗
Other Cook Incorporated products
- Torcon NB79 models · 36 reports · 68 recalls
- Flexor134 models · 1,437 reports · 3 recalls
- Instinct5 models · 1,289 reports · 1 recall
- Advance206 models · 816 reports
- Gunther Tulip5 models · 807 reports
- Hemospray2 models · 535 reports · 4 recalls
- NCircle10 models · 725 reports
- Roadrunner28 models · 183 reports · 9 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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