Celt ACD PLUS Vascular Closure Device 5F CLT-05Recalls & reported problems
Vasorum Limited · Celt ACD PLUS Vascular Closure Device 5F (US). · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05391530280617), received between Mar 24, 2026 and May 8, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (2 reports).
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
- Migration2
- Difficult or Delayed Separation1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2026Use of Device Problem; Migration
IT WAS REPORTED VIA MEDSUN THAT A CELT PLUS 5F IMPLANT WAS EMBOLIZED ON RELEASE FROM THE DELIVERY SYSTEM INTO A BRANCH OF THE COMMON FEMORAL ARTERY. THE POSITION OF THE IMPLANT IN THE SIDE BRANCH WAS STABLE, AND THE LOCATION WAS DEEMED BY THE OPERATOR NOT TO BE HARMFUL FOR THE PATIENT. NO ATTEMPT WAS MADE TO RETRIEVE THE IMPLANT. THE PATIENT WAS INFORMED AND HAD NO SYMPTOMS. HAEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123673 ↗InjuryMar 24, 2026Migration; Difficult or Delayed Separation
IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED CLOSURE WITH 5F CELT ACD PLUS. DURING CLOSURE THE OPERATOR PERFORMED STEP 1 AND 2 OF DEPLOYMENT UNDER ULTRASOUND GUIDANCE AND UTILIZING THE BLOOD SIGNAL, BUT WHEN ATTEMPTED TO EJECT/DETACH THE IMPLANT THE LEVER WOULDN'T MOVE WITH THE USUAL FORCE APPLIED. OPERATOR THEN INCREASED THE PRESSURE AND THE IMPLANT DETACHED AND MIGRATED DOWNSTREAM, BECOMING LODGED IN A SIDE BRANCH OF THE SUPERFICIAL FEMORAL ARTERY. THE CLOSURE PROCEDURE WAS COMPLETED WITH MANUAL PRESSURE AND HEMOSTASIS WAS ACHIEVED. PATIENT WAS STABLE AND DISCHARGED SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673375 ↗
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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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