Disposable High Speed Cutter 25G/8000CPM 8267.VIT25Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717872019086), received between Oct 12, 2017 and Jul 5, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K190875); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2018Device Operational Issue; Device Operational Issue

  THE VITRECTOR OPENED UP AND DURING SURGERY THE END USER MUST OPEN ANOTHER DUE THE BUBBLE IS COMING INTO THE EYE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7664948 ↗
• MalfunctionMay 15, 2018Device Operational Issue; Device Operational Issue

  PROBLEMATIC CUTTERS: BUBBLING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513962 ↗
• MalfunctionMay 11, 2018Device Operational Issue; Device Operational Issue

  THIS IS TO REPORT TO YOU THAT WE HAVE A BUBBLING ISSUE WITH 8267.VIT. OCCURED AT THE BEGINNING OF THE SURGERY WITH HIGHER CUT RATE. SAMPLE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508099 ↗
• MalfunctionMay 10, 2018Device Operational Issue; Device Operational Issue

  DOES NOT SUCK WELL AND SPITS AIR. ALL INFORMATION HAS BEEN DISCLOSED. SAMPLE AVAILABLE. NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7504436 ↗
• MalfunctionFeb 6, 2018Device Operational Issue; Device Operational Issue

  A REPORT HAS BEEN RECEIVED FROM (B)(6) REPORTING AIR BUBBLES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7245477 ↗
• MalfunctionOct 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS EVENT OCCURRED IN (B)(6). ACCORDING TO OUR CUSTOMER WHEN USING THE VITRECTOME AIR BUBBLES WERE CAUSED AND THE ASPIRATION WAS INSUFFICIENT. THIS EVENT OCCURRED DURING SURGERY. THERE IS NO INFORMATION THAT THE PATIENT WAS INJURED OR HARMED. THERE IS NO INFORMATION ON THE OUTCOME OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6946383 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190875. One submission often covers many models, so check the product and lot details in each record.

• Z-2252-2021 · May 21, 2019 · Open, Classified
  The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.