Micropuncture G13117Recalls & reported problems
Cook Incorporated · Micropuncture, Introducer Set Push-Plus Design STIFFENED CANNULA With 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
- 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 00827002131170), received between Jan 11, 2018 and Jan 11, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- 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.
MalfunctionJan 11, 2018Fracture; Fracture
IT WAS REPORTED THAT DURING AN ANTEGRADE FEMORAL ACCESS PROCEDURE, THE MICROPUNCTURE TRANSITIONLESS ACCESS SET 20 SONOMETER CANNULA (LOT NS8301674) FRACTURED DURING AN EXCHANGE (MEDWATCH 1820334-2018-00118). THE FRACTURE OCCURRED PRIOR TO INSERTION IN THE PATIENT, AND WAS EASILY REMOVED OFF THE WIRE GUIDE. ANOTHER ACCESS SET (MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET LOT 8037268) WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE; HOWEVER, THE CATHETER ACCORDIONED AND THE HUB SEPARATED WHILE BEING PULLED FROM THE PATIENT (REFER TO MEDWATCH 1820334-2018-00119). THE PATIENT'S ANATOMY WAS NOTED TO BE SCARRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7183569 ↗
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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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