Bimanual irrigation/aspiration set.(20 gauge / 0.9 mm) 1270.BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717872002040), received between May 10, 2018 and May 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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

• MalfunctionMay 10, 2018Material Separation; Material Separation

  THIS CUSTOMER REPORTS THERE IS SOME KIND OF DUST (SUCH AS DIAMOND DUST) COMING FROM THE INSTRUMENT. SALES WOULD LIKE TO KNOW THE FOLLOWING NOW: IS THE SURFACE GLUED OR WELDED? WHAT ARE THE RISKS?

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7504847 ↗

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.