PMI P0012MRecalls & reported problems
Progressive Medical, Inc. · PMI PTFE Coated Modified Blade 2.5" (6.35cm) · Class 2
Data updated Oct 16, 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 00812608020348), received between Jul 27, 2026 and Jul 27, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Unintended Electrical Shock1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Activation, Positioning or Separation Problem; Unintended Electrical Shock
Initial reporter stated a patient experienced burns from an electrosurgical electrode during a breast augmentation on (b)(6) 2026 and the experience outcome was extended patient hospitalization. No further clinical details, patient demographics, or identifiers were provided in the initial report.Documented follow-up attempts for additional information were made on or around 06/26/2026, 07/03/2026, and 07/09/2026. The distributor that received the report also made several follow-up attempts between 06/04/2026 and 06/26/2026. No additional patient or event information could be obtained.
Patient problems: Burn(s)
MAUDE report 50016207 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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