Micropuncture G47708Recalls & reported problems
Cook Incorporated · Micropuncture Introducer Set Silhouette Transitionless With Platinum-Tipped Stainless Steel Wire Guide · Class 2
All models of Micropuncture (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002477087), received between Jan 10, 2017 and Sep 24, 2026 — classified as 1 injury, 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Material Separation1
- Split1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Unraveled Material
As reported, during an unknown procedure, a MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S wire unraveled while pulling the device out of the patient. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures or experience any adverse effects due to this event.Additional information has been requested but is not available at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881981 ↗MalfunctionJul 25, 2017Split
PRIOR TO USE IT WAS NOTED THAT THE INNER PORTION OF THE DILATOR WAS SPLIT IN TWO. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6739658 ↗InjuryJan 10, 2017Material Separation; Material Separation
IT WAS REPORTED A MICRO-PUNCTURE WIRE SHEARED OFF IN THE PATIENT. RESISTANCE WAS REPORTEDLY ENCOUNTERED DURING THE REMOVAL PROCESS AND THE WIRE WAS NOTED TO HAVE KINKING. THE SHEARED WIRE WAS RETRIEVED AND NO ADDITIONAL PROCEDURES WERE NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 6236687 ↗
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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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