Cook G01472Recalls & reported problems
Cook Incorporated · Dilator · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002014725), received between Jul 18, 2017 and Jul 18, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's 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, 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.
Recalls naming this device
- Mar 1, 2024Open, Classified
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1530-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2017Break; Break
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING AN UNSPECIFIED IMPLANT PROCEDURE USING A DILATOR. THE TIP OF THE DILATOR REPORTEDLY BROKE OFF WHILE INSERTING THE DEVICE OVER A WIRE. THE PORTION OF THE BROKEN TIP WAS RETRIEVED. NO FURTHER EVENT DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED RELATING TO THE DEVICE HANDLING AND PATIENT OUTCOME. THE DEVICE IS AVAILABLE FOR EVALUATION.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 6721066 ↗
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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 · each recall links to the FDA recall notice
- 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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