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Lubri-Sil® I.C. Complete Care® All-Silicone Foley Catheter Tray and Urine Meter 307416ARecalls & reported problems

C. R. Bard, Inc. · Lubri-Sil® I.C. Complete Care® All-Silicone Foley Catheter Tray and Urine Meter · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741019760), received between May 1, 2019 and May 1, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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

Device problems

  • Deflation Problem1
  • Device Dislodged or Dislocated1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMay 1, 2019Deflation Problem; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE BALLOON OF THE COUDE CATHETER PREMATURELY DEFLATED AND THE CATHETER FELL OUT OF THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 8570591 ↗

Other CATHETER, RETENTION TYPE, BALLOON devices

All CATHETER, RETENTION TYPE, BALLOON devices →

Sources and updates

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