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PowerPICC® Catheter 9275108Recalls & reported problems

Bard Access Systems, Inc. · PowerPICC® Catheter with Sherlock Tip Location System (TLS) Stylet 5F Dual-lumen Full Tray · Class 2 · Implant

All models of PowerPICC Catheter (33)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741035685), received between Jan 16, 2018 and Oct 9, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 16, 2026.

Most reported problems

Device problems

  • Detachment Of Device Component1
  • Material Frayed1

Patient problems

  • Foreign Body In Patient1
  • 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.

  • InjuryOct 9, 2019Material Frayed; Material Frayed

    IT WAS REPORTED THAT THE GUIDE WIRE BROKE DURING INSERTION OF A PICC . IT WAS STATED ANGIO HAD TO "FISH OUT" THE BROKEN END. IT WAS REPORTED THE PLACER COULD NOT GET THE WIRE TO GO DOWN SVC. IT HAD COILED BACK ON ITSELF. SENT TO INVASIVE RADIOLOGY TO FIX.

    Patient problems: Foreign Body In Patient

    MAUDE report 9173527 ↗
  • MalfunctionJan 16, 2018Detachment Of Device Component

    IT WAS REPORTED BY THE FACILITY THAT THEY PLACED A DUAL LUMEN PICC ON (B)(6)2017 IN A PATIENT IN THE MICU. IT WAS STATED THAT ON (B)(6) 2017 THE PURPLE LUMEN SIDE CAME UNATTACHED TO THE Y-HUB AND THE PICC HAD TO BE PULLED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7195281 ↗

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Sources and updates

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