Angios Classic Angiographic Convenience Kit ANG4-0041Recalls & reported problems
Oscor Inc. · Angiographic Convenience Kit, 6F · 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 00885672101480), received between Mar 2, 2017 and Mar 2, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2017Detachment Of Device Component; Detachment Of Device Component
THE CUSTOMER REPORTED DURING THE CATHETERIZATION OF OSTIUM OF LCA BY ANGIOS CATHETER ON GUIDE WIRE AFTER THE SINGLE TURN OF CATHETER FROM LEFT TO RIGHT SINUS THE LOSS OF CONTROLLABILITY OCCURRED. THE ATTEMPT TO WITHDRAW CATHETER ON GUIDE WIRE LED TO THE RUPTURE AND ONLY 1/3 OF CATHETER WAS WITHDRAWN FROM THE BODY. ON X-RAY THE 2/3 OF DIAGNOSTIC CATHETER LEFT IN ASCENDING AORTA. ACCORDING TO THE CUSTOMER, THE INCIDENT DATE WAS (B)(6) 2014.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6373618 ↗
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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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