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3M™ Vac® CAPULTDEV01/USRecalls & reported problems

Kci USA, Inc. · 3M™ Vac® Ulta Therapy Unit CAPULTDEV01/US · 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 00849554008366), received between Apr 26, 2023 and Apr 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Suction Failure” (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.

Most reported problems

Device problems

  • Suction Failure1

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.

  • MalfunctionApr 26, 2023Suction Failure

    WOUND VACUUM ATTACHED TO PATIENT, SHOWS THAT IT IS RUNNING- HOWEVER, ASSESSMENT OF THE WOUND CLEARLY INDICATES THAT THERE IS NO SUCTION ON THE SPONGE DRESSING. TROUBLESHOOTING ATTEMPTED TO NO AVAIL. SCREEN SHOWS A TOTAL OF 44:56 OF CONTINUOUS VACUUM THERAPY, BUT EVIDENT NOT WORKING CORRECTLY. SYSTEM ERROR ON HISTORY READS- (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16814974 ↗

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Sources and updates

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