Advance Plus 97164Recalls & reported problems
Hollister Incorporated · Closed System Intermittent Catheter Kit, 16 Fr 16 in, Coude · Class 2
Data updated Oct 16, 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 00610075971640), received between Aug 6, 2026 and Aug 6, 2026 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- 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.
InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Urinary Tract Infection
MAUDE report 50155601 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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