Universal PVC infusion line for 23G cannula system for VFI/VFE 1279.VFIRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717872003351), received between Mar 21, 2018 and May 11, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THE SURGEON DISCOVERED WHITE STAINS ON THE TROCAR. SAMPLE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7506755 ↗
• MalfunctionMay 11, 2018Infusion or Flow Problem; Infusion or Flow Problem

  THE COMPLAINANT INFORMED DUTCH THAT THE INFUSION LINE HAD SOME SORT OF PLUG IN IT THAT WAS RESTRICTING FLOW. THE ISSUE WAS NOTICED APPROX. HALFWAY THROUGH A CASE / SURGERY. NO INJURY TO THE PATIENT OCCURRED AS A RESULT OF THIS INCIDENT. THE COMPLAINT ITEM WILL BE SENT TO DORC. ALL INFORMATION PERTAINING TO THIS INCIDENT HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7506262 ↗
• MalfunctionMar 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  A REPORT HAS BEEN RECEIVED FROM AN EVENT THAT OCCURRED IN (B)(6). THE FOLLOWING HAS BEEN REPORTED: " NO OR MINIMAL IRRIGATION FROM THE INFUSION LINE DURING SURGERY. DURING PRIMING THERE WAS NORMAL IRRITATION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7359485 ↗

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.