Micropuncture G49472Recalls & 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 00827002494725), received between Jun 29, 2022 and Jun 29, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem1
- Material Puncture/Hole1
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.
MalfunctionJun 29, 2022Material Puncture/Hole; Contamination /Decontamination Problem; Material Puncture/Hole; Contamination /Decontamination Problem
AS REPORTED, DURING A PROCEDURE INVOLVING LASER ABLATION, EXTRA PLASTIC MATERIAL WAS NOTED ON THE OUTSIDE OF A MICROPUNCTURE LONG INTRODUCER SET'S INTRODUCER. THE USER NOTED THE MATERIAL DURING ATTEMPTED INSERTION OF THE DEVICE INTO THE BOTTOM OF THE GREAT SAPHENOUS VEIN, TWO-TO-THREE CENTIMETERS ABOVE THE INSIDE OF THE KNEE. THE USER COULD NOT CONFIRM IF THE DEVICE MADE PATIENT CONTACT. THE DEVICE WAS REMOVED FROM THE FIELD AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14859235 ↗
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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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