SeQure SQ28_LB_150Recalls & reported problems
Accurate Medical Therapeutics Ltd · SeQure Microcatheter - 2.8 Fr., 150 cm, used with Large Beads · Class 2
Data updated Oct 13, 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 07290017268088), received between Mar 22, 2024 and Mar 22, 2024 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2024Break; Break
THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) ON 06 MARCH 2024. FACILITY REPORTS THAT SEQURE 2.8FR-150CM MICROCATHETER NORMAL PRE-PROCEDURE PREPARATION DONE. MICROCATHETER FLUSHED WITH SALINE. ADVANCED GUIDEWIRE WITHOUT RESISTANCE. STARTED EMBOLIZATION WITH EMBOZENES (250 MICRONS AND THEN 400 MICRONS). CONTOUR PARTICLES (355 -500) MIXED WITH CONTRAST MEDIA (IMERON 300) AND SALINE. APPROXIMATELY 10ML IMERON INJECTED AT A 80/20 DILUTION WITH SALINE. NO EVENT OBSERVED AT THIS STAGE. SEQURE 2.8FR-150CM MICROCATHETER WAS STILL INSERTED INSIDE THE PATIENT WHEN A SMALL ARTERIAL VASOSPASM WAS REALISED (INJECTED 0.25 MG VERAPAMIL INTRA-ARTERIALLY TO COUNTER THE SPASM). PROCEDURE WAS ALMOST DONE WHEN THE DOCTOR DECIDED TO INJECT MORE CONTOUR PARTICLES. SEQURE 2.8FR-150CM MICROCATHETER WAS FLUSHED INSIDE OF THE PATIENT WITH SALINE AND MET WITH RESISTANCE. DOCTOR ASKED FOR A GUIDEWIRE TO ADVANCE AND OPEN THE BLOCKAGE. DOCTOR THOUGHT THE GUIDEWIRE HAD ADVANCED AS THE RESISTANCE WAS RELIEVED. SAW ON IMAGING THAT THE TIP OF THE SEQURE 2.8FR-150CM MICROCATHETER HAD BROKEN OFF. AT THIS STAGE, EVERYTHING WAS REMOVED. PREPARATION FOR A PROGRADE CATHETER AND INJECTED CONTOUR PARTICLES (300-550) WITHO
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18959258 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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