Peel-Away G11559Recalls & reported problems
Cook Incorporated · Peel-Away, Introducer Set · Class 2
All models of Peel-Away (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002115590), received between Dec 12, 2014 and Dec 12, 2014 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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 16, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- Nonresorbable materials, unretrieved in body1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2014Material Separation
INITIAL INFORMATION PROVIDED STATED THAT THE WIRE GUIDE GOT STUCK IN VESSEL AND COULD NOT BE MOVED. EVENTUALLY THE PHYSICIAN FREED THE WIRE GUIDE, BUT A SMALL PIECE OF PRODUCT REMAINED IN THE PATIENT. ADDITIONAL INFORMATION PROVIDED STATED: "AFTER VEIN PUNCTURE, THEY INSERTED WIRE, BUT THE WIRE WAS NOT IN THE VEIN. THE WIRE GOES PARAVASAL. THEN THEY WANT TO REMOVE THE WIRE, BUT IT WAS NOT POSSIBLE TO REMOVE THE WIRE. THEN THEY REMOVED THE NEEDLE. AFTER THIS THEY REMOVED THE WIRE WITH FULL FORCE. BY THIS THE PLATINUM TIP OF THE WIRE DISBAND, AND BECOME LONGER. THEY REMOVED THE WIRE, ONLY A LITTLE PIECE STUCK IN THE PATIENT'S BODY.
Patient problems: Nonresorbable materials, unretrieved in body
MAUDE report 4346020 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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