Micropuncture Silhouette G53578Recalls & reported problems
Cook Incorporated · Micropuncture Introducer Set Silhouette Transitionless Design with Nitinol Wire Guide and EchoTip Needle · Class 2
Data updated Oct 18, 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 00827002535787), received between Dec 4, 2024 and Dec 4, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Unraveled Material” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unraveled Material1
Patient problems
- Hematoma1
- Reduced Blood Flow1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2024Unraveled Material; Unraveled Material
AS REPORTED, DURING PLACEMENT OF A PERCUTANEOUS CENTRAL LINE IN THE LEFT FEMORAL VEIN, A MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S WIRE UNRAVELED UPON REMOVAL. ULTRASOUND GUIDED ACCESS WAS OBTAINED IN THE LEFT FEMORAL VEIN, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO INSERTION AND ADVANCEMENT OF THE WIRE GUIDE. THE ACCESS SITE WAS REPORTEDLY NORMAL, AND NO PRIOR ATTEMPTS HAD BEEN MADE TO OBTAIN VASCULAR ACCESS AT THE SITE. THE USER ATTEMPTED TO REMOVE THE WIRE THROUGH THE ENTRY/ACCESS NEEDLE, AND RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE ¿LAST PART¿ OF THE WIRE, AT WHICH POINT THE MIDDLE SECTION OF THE WIRE UNRAVELED AND BECAME STUCK. PER THE REPORTER, THE WIRE WAS ABLE TO BE REMOVED MANUALLY THROUGH THE ENTRY NEEDLE, WITH THE END OF THE WIRE INTACT. A NEW WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. REPORTEDLY, THE PATIENT DEVELOPED A HEMATOMA AROUND THE ACCESS SITE BECAUSE OF THE EVENT, WITH SUBSEQUENT DISCOLORATION OF THE LEG. DIRECT PRESSURE WAS APPLIED FOR ¿SOME TIME¿, THE LIMB WAS ELEVATED, AND WARM COMPRESSES WERE APPLIED. EXTRA CLINICAL MONITORING WAS REQUIRED, INCLUDING USE OF ULTRASOUND AND DOPPLER. A SECTION OF THE DEVICE DID NO
Patient problems: Hematoma; Reduced Blood Flow
MAUDE report 20846582 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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