Navarre Opti-Drain NOD12PTRecalls & reported problems
Bard Access Systems, Inc. · Navarre Opti-Drain Multi-Use Drainage Catheter, Pigtail, 12 Fr x 30 cm · Class 1
All models of Navarre Opti-Drain (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741037078), received between Feb 28, 2017 and Mar 1, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Crack1
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2017Break; Fluid/Blood Leak
IT WAS REPORTED THAT THE IMPLICATED CATHETER WAS INSERTED IN THE ANGIOGRAPHY SUITE ON (B)(6) 2017 AND THE PATIENT WAS SENT BACK TO THE WARD. THE DOCTOR/NURSE FOUND THE TUBE LEAKING THE NEXT DAY AND REPORTED A BROKEN HUB. THE PATIENT WAS SENT TO BACK TO THE ANGIO SUITE FOR TUBE REPLACEMENT. THE CATHETER WAS REPLACED BY INTERVENTIONAL RADIOLOGIST. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 6370397 ↗MalfunctionFeb 28, 2017Crack
IT WAS REPORTED THAT THE WARD NURSE FOUND A CRACK OVER THE HUB OF THE DRAINAGE CATHETER. THE CATHETER WAS REPLACED BY AN INTERVENTIONAL RADIOLOGIST. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6364927 ↗
Other CATHETER, IRRIGATION devices
- Navarre Opti-Drain NOD8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION901 reports
- Navarre NNU8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION736 reports
- BLAKE 2227Ethicon Inc. · CATHETER, IRRIGATION331 reports
- Navarre NNU6LPTBard Access Systems, Inc. · CATHETER, IRRIGATION211 reports
- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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