2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER MR190300Recalls & reported problems
Medical Components, Inc. · 3F (1.0MM ID) X 5CM TEARAWAY INTRODUCER SET W/NITINOL GUIDEWIRE W/RADIOPAQUE TIP · 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 00884908093728), received between Jun 21, 2017 and Jun 21, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling 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 18, 2026.
Most reported problems
Device problems
- Device Handling Problem1
- Failure to Advance1
- Sticking1
Patient problems
- No Code Available1
- 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.
InjuryJun 21, 2017Device Handling Problem; Sticking; Failure to Advance; Device Handling Problem
ATTEMPTING TO PLACE 2.6F PICC TO LEFT UPPER ARM USING 3F MST KIT BUT COULD NOT ADVANCE GUIDEWIRE. ON SECOND ATTEMPT THE GUIDEWIRE BECAME STUCK IN THE BABY'S ARM. OPERATOR ASSUMED THE PATIENT WAS HAVING VASOSPASM SO SHE MASSAGED THE ARM AND WAITED A FEW MINUTES BUT THE WIRE STILL FELT STUCK. PHYSICIAN WAS CALLED TO BEDSIDE TO ASSESS; HE PERFORMED A SKIN NICK TO PULL THE KNOTTED WIRE OUT. PATIENT WAS IN NO DISTRESS AT ANY POINT IN THE PROCEDURE.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 6658249 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
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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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