DuoGlide catheter 5626150Recalls & reported problems
Bard Access Systems, Inc. · 13Fr DuoGlide PC 15cm Tray · Class 2 · Implant
All models of DuoGlide catheter (11)
Data updated Oct 18, 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
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741042140), received between Dec 21, 2016 and Sep 23, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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 18, 2026.
Reports received per month
Recalls naming this device
- Aug 10, 2026Class IOpen, Classified
this is a downstream recall of class I recall RES 98777
Z-2985-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Most reported problems
Device problems
- Break2
- Kinked1
- Material Deformation1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- 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.
MalfunctionSep 23, 2026Break
It was reported by MedWatch temporary dialysis line port broke off (arterial/right/red port). The clamp came off as well with the distal port portion which caused the patient to bleed. This was identified by nursing and bleeding was controlled, clamp to stop bleeding. Line required replacement. No further information was provided.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50870561 ↗MalfunctionDec 21, 2016Break; Kinked; Material Deformation
PER SALES REPRESENTATIVE, THE ICU DEPARTMENT REPORTED THEY HAD A GUIDEWIRE ISSUE WITH A "DUAL GLIDE". NO ADDITIONAL INFORMATION PROVIDED WHEN REQUESTED. ON (B)(6) 2016 - PER ENGINEERING TECH, THE SAMPLE GUIDEWIRE RECEIVED FOR THIS FILE WAS STRETCHED, KINKED AND BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6197238 ↗
Other CATHETER, HEMODIALYSIS, NON-IMPLANTED devices
- MAHURKAR 8888135191Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall175 reports
- MAHURKAR 8888135241Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall1 death100 reports
- ARROW IPN036723Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls2 reports
- ARROW IPN036412Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- DuoGlide catheter 5625240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- ARROW IPN036428Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
- ARROW IPN036419Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
- ARROW IPN927343Teleflex Incorporated · Catheter, hemodialysis, non-implanted2 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page