Micropuncture G48005Recalls & reported problems
Cook Incorporated · Micropuncture Introducer Set Silhouette Transitionless Push-Plus Design 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 00827002480056), received between Apr 18, 2024 and Apr 18, 2024 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2024Break; Break
AS REPORTED, DURING A PERIPHERAL "ANGIO" INVOLVING THE RIGHT FEMORAL ARTERY, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE SEPARATED IN THE PATIENT WHILE TRYING TO GAIN ACCESS. ACCESS WAS OBTAINED USING ULTRASOUND, AND BLOOD RETURN WAS NOTED PRIOR TO INSERTION OF THE WIRE THROUGH THE ACCESS NEEDLE. REPORTEDLY, THE PATIENT WAS "VERY LARGE" AND THEREFORE, THE STICK WAS VERY DEEP AND STRAIGHT ON. THE SEPARATED WIRE FRAGMENT WAS SUCCESSFULLY RETRIEVED WITH SNARES. A NEW DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY 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 19136298 ↗
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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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