MEDLINE DYND13518Recalls & reported problems
Medline Industries, Inc. · CATHETER,URETHRAL,REDRUBBER,STRL,18FR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10080196031245), received between Jun 8, 2022 and Jun 8, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- May 4, 2026Open, Classified
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Z-2479-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2022Break
IT WAS REPORTED THAT THE CATHETER BROKE WHILE THE SURGEON WAS CANNULATING THE AORTA. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE.
Patient problems: Insufficient Information
MAUDE report 14634532 ↗
Other CATHETER, URETERAL, GASTRO-UROLOGY devices
- MEDLINE DYND13508Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall2 reports
- MEDLINE DYND13514Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall1 report
- MEDLINE DYND13510Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall1 report
- MEDLINE DYND13516Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall0 reports
- MEDLINE DYND13614Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall0 reports
- MEDLINE DYND13515Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall0 reports
- MEDLINE DYND13522Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall0 reports
- MEDLINE DYND13616Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall0 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 · each recall links to the FDA recall notice
- 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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