Micropuncture G49473Recalls & reported problems
Cook Incorporated · Micropuncture Introducer Set With Nitinol Wire Guide · Class 2
All models of Micropuncture (39)
Data updated Oct 16, 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 00827002494732), received between Jul 23, 2021 and Jul 23, 2021 — classified as 1 malfunction.
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
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2021Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED. PER THE REPORTER, THE TIP OF THE DEVICE WAS TOO TIGHT AND AN UNKNOWN LASER WOULD NOT FIT THROUGH THE END HOLE OF THE SHEATH.
Patient problems: Insufficient Information
MAUDE report 12218622 ↗
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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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