Apogee B1061Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00610075176724), received between Dec 8, 2025 and Mar 13, 2026 — classified as 2 injuries.

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

5 other recalls cover devices cleared under the same FDA submission (K992137); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 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 STRAIGHT 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 24598950 ↗
• InjuryDec 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A UTI. THEY WERE REPORTED TO BE USING THE HOLLISTER APOGEE INTERMITTENT CATHETER. NO MEDICAL ATTENTION WAS REPORTED. IT WAS ALSO REPORTED THAT THE PATIENT STATED THAT "THESE DID WORK" AND THAT THEY HAD USED THEM BEFORE. NO FURTHER CONTACT WITH THE PATIENT IS POSSIBLE, DUE TO LACK OF CONTACT INFORMATION. NO LOT NUMBER PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23747396 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K992137. One submission often covers many models, so check the product and lot details in each record.

• Z-2394-2008 · Jul 17, 2008 · Terminated
  Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to dr
• Z-2393-2008 · Jul 17, 2008 · Terminated
  Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to d
• Z-2391-2008 · Jul 17, 2008 · Terminated
  Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from
• Z-2390-2008 · Jul 17, 2008 · Terminated
  Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from
• Z-2392-2008 · Jul 17, 2008 · Terminated
  Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from