MEDLINE DYND13508Recalls & reported problems
Medline Industries, Inc. · CATHETER,URETHRAL,REDRUBBER,STERILE,8FR · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196031139), received between Jun 18, 2018 and Jul 18, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Malposition of Device1
- Off-Label Use1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2018Off-Label Use
IT WAS REPORTED THAT THE URETHRAL CATHETER WAS BEING USED TO MAINTAIN TRACHEOSTOMY STOMA PATENCY. REPORTEDLY, THE DEVICE BECAME LODGED IN THE PATIENT'S LEFT BRONCHUS AND AN UNIDENTIFIED PROCEDURE WAS REQUIRED TO REMOVE THE URETHRAL CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7697751 ↗MalfunctionJun 18, 2018Malposition of Device; Device Dislodged or Dislocated
RED RUBBER CATHETER WAS PLACED IN PATIENT'S TRACHEOSTOMY STOMA TO MAINTAIN PATENCY. THE CATHETER BECAME LODGED IN THE LEFT BRONCHUS AND WAS SUBSEQUENTLY REMOVED IN OR.
Patient problems: No Code Available
MAUDE report 7609368 ↗
Other CATHETER, URETERAL, GASTRO-UROLOGY devices
- MEDLINE DYND13518Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall1 report
- 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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