VENAPAX XL VPX4000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888233078986), received between Mar 23, 2026 and Mar 23, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K140603); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Overheating of Device

  IT WAS REPORTED THAT AT THE END OF SURGERY, THE PATIENT WAS FOUND TO HAVE THREE FULL-THICKNESS ONE-INCH THERMAL BURNS ALONG THE VEIN HARVEST PATH ON THE LEFT INNER THIGH FOLLOWING USE OF AN ENDOSCOPIC VEIN HARVESTING DEVICE. THE BURNS WERE IDENTIFIED AFTER DRAPES WERE REMOVED. THE LEG WAS WRAPPED WITH AN ELASTIC BANDAGE, AND THE WOUNDS WERE DOCUMENTED FOR ONGOING TRACKING, ASSESSMENT, AND TREATMENT AS NEEDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 24670316 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140603. One submission often covers many models, so check the product and lot details in each record.

• Z-0285-2025 · Sep 17, 2024 · Open, Classified
  Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients