MicroDoc NPWT System 8463550 4003Recalls & reported problems
Pensar Medical, LLC · MicroDoc NPWT System, each, with 10cm x 30cm (5cm x 25cm) Dressings · 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 00851978007528), received between Jun 22, 2026 and Jun 22, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Gas/Air Leak” (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.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak1
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.
MalfunctionJun 22, 2026Gas/Air Leak
CUSTOMER (B)(6) REPORTED POTENTIAL QUALITY ISSUES WITH THE MICRODOC WOUND DRESSING (P/N 4013 (SYSTEM P/N 4003, LOT 20250120)); THE DRESSING WAS REPORTED AS HAVING A LEAK. CUSTOMER STAFF PROVIDED ADDITIONAL APPLICATION TRAINING TO BEST PRACTICES IN AVOIDING LEAKS THROUGH ADHESIVE DRESSING APPLICATION. PATIENT(S) REQUIRED A NEW WOUND DRESSING. DEVICES WERE NOT RETURNED. REPLACEMENT PRODUCT PROVIDED. CONSERVATIVE DETERMINATION: MDR REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25577893 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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