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
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.
- 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.
- Instinct G58010Hemostatic metal clip for the GI tract1 recall1,017 reports
- Instinct G18343Hemostatic metal clip for the GI tract244 reports
- Instinct G18344Hemostatic metal clip for the GI tract21 reports
- Instinct G24653Hemostatic metal clip for the GI tract4 reports
- Instinct G57302Unit, electrosurgical, endoscopic (with or without accessories)3 reports
Recent Instinct adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Fire
During endoscopic procedure to clip on ulcer, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that the clip would not release from the catheter but was able to reopen from tissue.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 50947275 ↗MalfunctionSep 30, 2026Failure to Fire
During an endoscopic clipping procedure, the physician used two Cook Instinct Plus Endoscopic Clipping Devices. It was reported that the clips failed to deploy and were able to be reopened from tissue.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 50946848 ↗MalfunctionSep 30, 2026Failure to Fire
During clipping in the sigmoid post polyp removal, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that the clip closed perfectly but once "[the user]" crunched, the clip did not deploy, (heard the deployment) but the clip was still on the catheter.Another clip was used and deployed perfect as it should.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 50946716 ↗MalfunctionSep 28, 2026Activation, Positioning or Separation Problem
Clip would not deploy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913184 ↗MalfunctionSep 25, 2026Separation Failure; Failure to Fire
During clipping to stop bleeding post polypectomy in the colon, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that the forceps "[jaws]" open and close, but the clip does not release, despite attempts to reposition the clip and the forceps "[jaws]", and efforts by the surgeon and nursing staff.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 50898572 ↗MalfunctionSep 25, 2026Failure to Fire
During an endoscopic clipping procedure, the physician used multiple Cook Instinct Plus Endoscopic Clipping Devices. It was initially reported that the clip was not opening. There was no reportable information at that time. Additional information received on 28 Aug 2026 indicated that the clip was unable to deploy but able to open from tissue "[subject of report]".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 50896370 ↗MalfunctionSep 24, 2026Failure to Fire
During an endoscopic clipping procedure, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that the clip did not deploy but could be reopened. Another clip was used to finish the procedure. 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 50886245 ↗MalfunctionSep 24, 2026Material Separation; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884335 ↗MalfunctionSep 24, 2026Separation Failure; Failure to Fire
During an endoscopic clipping procedure, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that while the clip was being inserted through the scope, the staff member was holding the red part of the handle, the clip could not be deployed.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 50883693 ↗MalfunctionSep 22, 2026Failure to Fire
During an endoscopic clipping procedure, the physician used two Cook Instinct Plus Endoscopic Clipping Devices. It was reported that the clips did not deploy. They get on tissue and they will not fire but they were able to reopen the clips to remove them from tissue. Another clip was grabbed to complete the procedure.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 50852526 ↗MalfunctionSep 21, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50844970 ↗MalfunctionSep 21, 2026Failure to Fire
During an endoscopic clipping procedure, the physician used two Cook Instinct Plus Endoscopic Clipping Devices. It was reported that the clips did not deploy. They get on tissue and they will not fire but they were able to reopen the clips to remove them from tissue. Another clip was grabbed to complete the procedure.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 50842532 ↗MalfunctionSep 21, 2026Failure to Fire
During a gastroscopy, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that the clip was not able to deploy when activated and it still didn't work when out of scope.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 50842421 ↗MalfunctionSep 21, 2026Separation Failure; Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841989 ↗MalfunctionSep 19, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832569 ↗
Other Cook Incorporated products
- Torcon NB79 models · 36 reports · 68 recalls
- Flexor134 models · 1,437 reports · 3 recalls
- Saeed15 models · 863 reports
- 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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