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Power-Trialysis Slim-Cath catheter 5865150Recalls & reported problems

Bard Access Systems, Inc. · 12Fr Trialysis PC 15cm Tray · Class 2

All models of Power-Trialysis Slim-Cath 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
1
Deaths reported
1
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741107207), received between Jul 1, 2016 and Jul 1, 2016 — classified as 1 death.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Recalls naming this device

  1. Aug 10, 2026Class IOpen, Classified

    this is a downstream recall of class I recall RES 98777

    Z-2984-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • Death1
  • Low Blood Pressure/ Hypotension1
  • Sepsis1
  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathJul 1, 2016Insufficient Device Problem Information

    AS REPORTED VIA MS&S: SALES REPRESENTATIVE HAD NURSE CONFERENCE CALL WITH MS&S. THE NURSE STATED THAT THEY HAD A FEMALE PATIENT WITH KNOWN SEPSIS WHO HAD A POWER TRIALYSIS PLACED ON (B)(6) 2016. THE NURSE STATED THAT THE PATIENT'S CHEST AND NECK VEINS WERE EXHAUSTED AND THE RIGHT GROIN HAD AN INFECTION. THE POWER TRIALYSIS WAS PLACED INTO THE LEFT FEMORAL VEIN BUT WAS ONLY 15CM IN LENGTH. THE NURSE STATED THAT THE VENOUS PURPLE LUMEN WAS BEING USED FOR VASOPRESSORS LEVOPHED AND DOPAMINE DURING CCRT. THE NURSE REPORTED THAT THE PATIENT'S BLOOD PRESSURE WAS LOW AND THEN WOULD ELEVATE. NURSE STATED THAT THE PATIENT DETERIORATED. THE FAMILY STOPPED TREATMENT AND THE PATIENT EXPIRED. THE NURSE ASKED IF IT IS PERMITTED TO GIVE VASOPRESSORS THROUGH THE DIALYSIS CATHETER PURPLE LUMEN VENOUS LUMEN. THE NURSE STATED THAT THE CATHETER WAS NOT SAVED. MS&S INFORMED THE NURSE THAT IT IS NOT CONTRAINDICATED TO GIVE VASOPRESSORS THROUGH THE VENOUS PURPLE LUMEN OF THE CATHETER.

    Patient problems: Death; Low Blood Pressure/ Hypotension; Sepsis; Unspecified Infection

    MAUDE report 5764946 ↗

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

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

Sources and updates

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