Apogee IC 10810Recalls & reported problems
Hollister Incorporated · Intermittent catheter, 8 Fr 10 in, Straight · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00610075205134), received between Nov 11, 2024 and Nov 11, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT AN END USER WHO USES THE APOGEE INTERMITTENT CATHETER TO IRRIGATE HIS MALONE APPENDICOSTOMY STOMA, HAD THE CATHETER MIGRATE INTO HIS COLON AND REQUIRED A COLONOSCOPY TO RETRIEVE. IT WAS REPORTED THAT THE END USER INSERTED THE CATHETER INTO THE STOMA AND TAPED IT TO HIS SKIN. ABOUT TWO HOURS LATER, HE WENT TO FLUSH SALINE THROUGH THE CATHETER BUT FOUND ONLY THE BLUE FUNNEL PRESENT. IT WAS REPORTED THAT THE CATHETER BODY MIGRATED INTO THE STOMA DURING THE TWO HOURS IT WAS TAPED TO HIS BODY. IT WAS REPORTED THAT DESPITE NUMEROUS IRRIGATIONS WITH THE APOGEE INTERMITTENT CATHETER OVER THE NEXT SEVERAL DAYS, THE CATHETER BODY WOULD NOT COME OUT RECTALLY. IT WAS REPORTED THAT 5 DAYS AFTER THIS REPORTED CATHETER MIGRATION, HE HAD A COLONOSCOPY PERFORMED RECTALLY AND THE CATHETER WAS LOCATED AND RETRIEVED. IT WAS REPORTED THAT THE END USER FELT FINE AFTER THIS PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20651486 ↗
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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