Apogee IC 11416Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00610075205240), received between Apr 15, 2024 and Apr 15, 2024 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WHEELCHAIR BOUND PARAPLEGIC END USER WHO USES THE HOLLISTER APOGEE INTERMITTENT URINARY CATHETERS HAD ONGOING PAIN AND DISCOMFORT IN HIS BLADDER. IT WAS REPORTED THAT THIS PAIN HAD BEEN ONGOING FOR 6 MONTHS. IT WAS FURTHER REPORTED THAT THE END USER BELIEVES THE CATHETER PACKAGES DID NOT HAVE AIRTIGHT SEALS. IT WAS REPORTED THAT THE END USER'S UROLOGIST PRESCRIBED THE USE OF FOLEY CATHETERS INSTEAD. IT WAS FURTHER REPORTED THAT THE END USER SWITCHED BACK TO THE HOLLISTER APOGEE CATHETERS IN FEBRUARY AND SEVERAL WEEKS LATER, HIS TESTICLE HAD SWOLLEN TO THE SIZE OF A TENNIS BALL. IT WAS REPORTED THAT HE WENT TO THE EMERGENCY ROOM AND WAS DIAGNOSED WITH EPIDIDYMITIS WITH HYDROCELE. IT WAS FURTHER REPORTED THAT THE END USER WAS ADMITTED TO THE HOSPITAL FOR 5 DAYS AND WAS PRESCRIBED TWO WEEKS OF BEDREST, ICE & ANTIBIOTICS AT DISCHARGE.

  Patient problems: Swelling/ Edema

  MAUDE report 19105322 ↗