Soft-Cell Dialysis Catheter Kit 12.5 F x 19 cm 5533690Recalls & reported problems
Bard Access Systems, Inc. · SOFT-CELL DIALYSIS CATH, ST, DL, 12.5 FR. 19cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741012426), received between Jul 18, 2017 and Jul 18, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT THE PIN HALL ON THE CATHETER PLACED OUT SIDE OF THE PATIENT BODY WAS FOUND WHEN IT WAS PLACED. THE CATHETER WAS REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6722186 ↗
Other CATHETER, SUBCLAVIAN devices
- Permcath 8817748001Mozarc Medical US LLC · CATHETER, SUBCLAVIAN2 deaths34 reports
- ARROW IPN030063Teleflex Incorporated · CATHETER, SUBCLAVIAN30 reports
- Hemo-Cath® SL18PMedical Components, Inc. · CATHETER, SUBCLAVIAN1 death25 reports
- Soft-Cell PC-2 Dialysis Catheter Kit 12.5 F x 19 cm 5534190Bard Access Systems, Inc. · CATHETER, SUBCLAVIAN17 reports
- Schon 10800702Angiodynamics, Inc. · CATHETER, SUBCLAVIAN8 reports
- ARROW IPN919725Teleflex Incorporated · Catheter, subclavian7 reports
- Permcath 8817749001Mozarc Medical US LLC · CATHETER, SUBCLAVIAN7 reports
- ARROW IPN919724Teleflex Incorporated · Catheter, subclavian6 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.
How reports and recalls are matched · Editorial policy · Report an error on this page