Peel-Away G11567Recalls & reported problems
Cook Incorporated · Peel-Away Introducer Set · Class 2
All models of Peel-Away (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002115675), received between Oct 9, 2017 and Oct 9, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
- Peeled/Delaminated1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2017Break; Peeled/Delaminated; Device Dislodged or Dislocated
UPON OPENING THE PACKAGE IN THE BEGINNING OF THE SURGERY, THE NURSE DISCOVERED THE ABNORMAL PEEL OFF BETWEEN THE TOP AND THE TUBE. IT WAS FURTHER NOTED THAT THE SHEATH HAD SEPARATED FROM THE TABS AND THE SHEATH MATERIAL THAT WAS ATTACHED TO THE PULL TABS HAD SIGNS OF THE MATERIAL BEING SLICED. THERE WAS NO HARM TO THE PATIENT AS THE DEVICE DID NOT MAKE PATIENT CONTACT. THE DEVICE WAS IMMEDIATELY SWITCHED WITH ANOTHER BRAND'S INTRODUCER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6930910 ↗
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- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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