PREVENA RESTOR BELLA•FORMRecalls & reported problems across all models
Kci USA, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PREVENA RESTOR BELLA•FORM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of PREVENA RESTOR BELLA•FORM by Kci USA, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
PREVENA RESTOR BELLA•FORM recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 17, 2025Open, Classified
Due to increase in complaints related to leak alarms
Z-1175-2025 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
Most reported PREVENA RESTOR BELLA•FORM problems
Device problems
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Known Impact Or Consequence To Patient1
PREVENA RESTOR BELLA•FORM models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PREVENA RESTOR™ BELLA•FORM™ PRE5355Negative Pressure Wound Therapy Powered Suction Pump1 recall1 report
- PREVENA RESTOR™ BELLA•FORM™ PRE5455Negative Pressure Wound Therapy Powered Suction Pump1 recall0 reports
- PREVENA RESTOR™ BELLA•FORM™ PRE5255Negative Pressure Wound Therapy Powered Suction Pump1 recall0 reports
Recent PREVENA RESTOR BELLA•FORM adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2020Therapeutic or Diagnostic Output Failure
UPPER MIDDLE-AGED FEMALE WITH HISTORY OF BREAST CANCER. DURING SURGERY FOR RIGHT BREAST MASTECTOMY, SENTINEL NODE BX AND RECONSTRUCTION THE PUMP WOULD NOT STAY ON TO WORK. ANOTHER DEVICE OBTAINED, NO KNOWN HARM TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10546285 ↗
Other Kci USA, Inc. products
All Kci USA, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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