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PowerPICC Catheter 3174135Recalls & reported problems

Bard Access Systems, Inc. · PowerPICC Catheter 4F Single-Lumen Polyurethane Catheter Radiology Basic Tray (135 cm Guidewire) · Class 2 · Implant

All models of PowerPICC Catheter (33)

Data updated Oct 16, 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
3
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741027604), received between Oct 8, 2019 and Jul 25, 2024 — classified as 3 malfunctions.

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

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Mar 11, 2025Open, Classified

    Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

    Z-1507-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

  • Defective Component1
  • Fluid/Blood Leak1
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1
  • Pain1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY THE CUSTOMER THAT FAULTY CATHETER. DEVICE WAS INSERTED ON (B)(6) 2023. ISSUE WAS NOTICED DURING A CT STUDY ON (B)(6) AND THE CATHETER WAS REMOVED ON THURSDAY, (B)(6) AS REQUESTED BY THE ORDERING PHYSICIAN. THE CONTRAST DID NOT GO THROUGH CAUSING THE PATIENT TO COMPLAIN AND EXPERIENCE PAIN. THE INJECTION WAS STOPPED. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Pain

    MAUDE report 19824541 ↗
  • MalfunctionSep 8, 2023Material Deformation; Material Deformation

    IT WAS REPORTED BY CUSTOMER THAT THE PICC KINKED INSIDE THE PATIENT. PICC HAD TO BE REMOVED AND REPLACED WITH NEW PICC. ADDITIONAL INFORMATION RECEIVED WED 09/06/2023: THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. PICC WAS KINKED AND NEEDED TO BE REPLACED. THERE WAS A DELAY IN GETTING PROPER IV THERAPY PER CUSTOMER. THE REMOVAL AND REPLACEMENT OF A PICC WAS PERFORMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17711894 ↗
  • MalfunctionOct 8, 2019Defective Component; Defective Component

    IT WAS REPORTED THAT WHEN IMPLANTING THE PICC CATHETER, DAMAGE TO THE GUIDE WIRE (EXCESSIVELY FRAGILE GUIDE WIRE) OCCURRED, INCREASING THE SURGERY TIME. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9167922 ↗

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

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

Sources and updates

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