Micropuncture G47946Recalls & reported problems
Cook Incorporated · Micropuncture Introducer Set Silhouette Transitionless 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002479463), received between May 3, 2023 and May 3, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
- Unraveled Material1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 2023Break; Unraveled Material; Break; Unraveled Material
AS REPORTED, DURING PLACEMENT OF A POWER PORT, A MICROPUNCTURE TRANSITIONLESS PEDIATRIC ACCESS SET'S WIRE UNRAVELED AND SEPARATED. THE WIRE WAS ADVANCED THROUGH THE MICROPUNCTURE NEEDLE; HOWEVER, THE WIRE WAS DIFFICULT TO ADVANCE. THE USER THEN ATTEMPTED TO REMOVE THE WIRE THROUGH THE NEEDLE, BUT THE WIRE WOULD NOT MOVE. THE USER PULLED ON THE WIRE AGAIN, AND THE WIRE BEGAN TO UNRAVEL. THE WIRE WAS REMOVED; HOWEVER, THE TIP SEPARATED IN THE PATIENT. FLUOROSCOPY WAS USED TO LOCATE THE WIRE FRAGMENT, AND AN INCISION WAS MADE FOR TISSUE EXPLORATION. THE WIRE FRAGMENT WAS LOCATED AND REMOVED FROM THE PATIENT. INTRAOPERATIVE FLUOROSCOPY CONFIRMED REMOVAL OF THE WIRE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 16863392 ↗
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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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