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PowerPICC® SV Catheter with Sherlock Tip Location System (TLS) Stylet 9173118Recalls & reported problems

Bard Access Systems, Inc. · PowerPICC SV Catheter 3F Basic Tray with MicroIntroducer (Single-Lumen) · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741028571), received between Feb 1, 2018 and Feb 28, 2020 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Break1
  • Material Frayed1

Patient problems

  • No Consequences Or Impact To 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.

  • MalfunctionFeb 28, 2020Material Frayed; Material Frayed

    IT WAS REPORTED THAT AT THE FACILITY WHILE INSPECTING THE GUIDEWIRE, THE TIP BROKE OFF EASILY. THE DEVICE WAS NOT USED ON A PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9769900 ↗
  • MalfunctionFeb 1, 2018Break

    IT WAS REPORTED BY THE FACILITY THAT THE HUB ON THE CATHETER BROKE OFF AT HOME, CLAMPED THE LINE AND PATIENT WAS IMMEDIATELY TAKEN TO THE EMERGENCY DEPARTMENT WHERE THE LINE WAS REMOVED AND A NEW LINE PLACED. NO HARM TO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7234987 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

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Sources and updates

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