Celt ACD PLUS Vascular Closure Device 6F CLT-06Recalls & reported problems
Vasorum Limited · Celt ACD PLUS Vascular Closure Device 6F (US) · Class 3 · Implant
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 05391530280648), received between Dec 16, 2025 and Dec 16, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2025Insufficient Device Problem Information; Separation Problem; Insufficient Device Problem Information; Separation Problem
IT WAS REPORTED THAT A PHYSICIAN DEPLOYED STEP ONE AND TWO, ATTEMPTED TO EJECT THE IMPLANT AND THE CLIP WOULDN'T DETACH AFTER THE LEVER WAS PUSHED. THE DELIVERY SYSTEM AND THE IMPLANT WAS PULLED OUT AND MANUAL PRESSURE APPLIED, FOLLOWED BY FEMSTOP APPLICATION. HEMOSTASIS WAS ACHIEVED. THE DEVICE IS BEING RETURNED TO VASORUM LTD FOR INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23817089 ↗
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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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