Apogee IC 11426Recalls & reported problems
Hollister Incorporated · Intermittent catheter, 14 Fr 16 in, Coude · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00610075205257), received between Mar 13, 2026 and Mar 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Hematuria1
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT A CUSTOMER EXPERIENCED BLEEDING AFTER UTILIZING THE HOLLISTER APOGEE COUDE INTERMITTENT URETHRAL CATHETER. IT WAS THEN REPORTED DURING A FOLLOW-UP CALL THAT THE CUSTOMER RECENTLY VISITED THE ER, WHERE HE WAS DIAGNOSED WITH PROSTATITIS AND A TESTICULAR INFECTION. ADDITIONALLY, IT WAS REPORTED THAT HE WAS PLACED ON A FOLEY CATHETER AND PRESCRIBED A ONE-MONTH COURSE OF ANTIBIOTICS.
Patient problems: Hematuria; Urinary Tract Infection
MAUDE report 24595408 ↗
Other CATHETER, URETHRAL devices
- Bardex® All-Silicone Foley Catheter 165814C. R. Bard, Inc. · CATHETER, URETHRAL275 reports
- GENTLECATH 421911Convatec, Purchasing Department · Catheter, Urethral234 reports
- GENTLECATH 421910Convatec, Purchasing Department · Catheter, Urethral122 reports
- CURE CATHETER M16CConvatec, Purchasing Department · Catheter, Urethral95 reports
- GENTLECATH 421909Convatec, Purchasing Department · Catheter, Urethral66 reports
- BD Intermittent RTU14FHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral1 recall3 reports
- Onli 82124Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
- Onli 82164Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.