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Power-Trialysis Alphacurve catheter 5653200Recalls & reported problems

Bard Access Systems, Inc. · 13Fr Trialysis Alphacurve 20cm Kit · Class 2

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 00801741066030), received between Jun 14, 2018 and Jun 14, 2018 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionJun 14, 2018Break

    IT WAS REPORTED THAT THE CLAMP ON THE BLUE LUMEN OF A TRIALYSIS CATHETER BROKE. THIS CATHETER WAS PLACED AND WAS THEN REPLACED OVER THE WIRE ONCE THE CLAMP BROKE. IT WAS STATED IT WAS NOT USED FOR DIALYSIS AND IT BROKE UPON INITIAL PLACEMENT. PATIENT WAS NOT HARMED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7603962 ↗

Other CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED devices

All CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.