EVA Cartridge with 0.5 L Collection Bag 8100.CAR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717872019178), received between Jul 12, 2018 and Jul 12, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Inability to Irrigate” (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.

• InjuryJul 12, 2018Inability to Irrigate; Material Twisted/Bent

  PROBLEM DESCRIPTION: DURING SURGERY, THE BLUE IRRIGATION LINE TWISTED ITSELF AND STOPPED IRRIGATION. FURTHER THE EYE WENT REALLY SOFT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7682728 ↗

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.