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Poly RadPICC Catheter 3264155Recalls & reported problems

Bard Access Systems, Inc. · Poly RadPICC Catheter 4F Dual-Lumen Polyurethane Catheter Basic Kit (70 cm Guidewire) · Class 2 · Implant

All models of Poly RadPICC Catheter (6)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741035098), received between Dec 4, 2015 and Mar 18, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective 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

  • Adverse Event Without Identified Device or Use Problem2
  • Defective Component1
  • Unraveled Material1

Patient problems

  • Unspecified Infection2
  • No Clinical Signs, Symptoms or Conditions1
  • No Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 18, 2022Defective Component; Defective Component

    IT WAS REPORTED "PICC LINE GREY LUMEN CLAMP NOT ALWAYS EFFECTIVE AT LOCKING. IN CERTAIN POSITIONS, THE LINE CAN STILL FLUSH WHILE THE CLAMP IS IN THE LOCKED POSITION." ADD INFO RCVD (B)(6) 2022: - WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? THIS PICC LINE HAD A SECURE-A -CATH SECUREMENT DEVICE AND WAS DRESSED WITH 3M TEGADERM IV ADVANCED DRESSING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13808947 ↗
  • InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED VIA HEALTH CANADA¿S MEDICAL DEVICES ONLINE DATABASES "E1906 - UNSPECIFIED INFECTIONF23 - UNEXPECTED MEDICAL INTERVENTIONF12 - SERIOUS INJURY ILLNESS IMPAIRMENTA26 - INSUFFICIENT INFORMATION." NO OTHER INFORMATION REGARDING THE EVENT WAS PROVIDED.

    Patient problems: Unspecified Infection

    MAUDE report 12309936 ↗
  • InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY THE HEALTH CANADA WEBSITE THAT A FACILITY REPORTED A UNSPECIFIED INFECTION . AN UNEXPECTED MEDICAL INTERVENTION AND SERIOUS INJURY ILLNESS IMPAIRMENT WAS REPORTED. NO FURTHER INFORMATION. CAUSE NOT ESTABLISHED.

    Patient problems: Unspecified Infection

    MAUDE report 10679312 ↗
  • MalfunctionDec 4, 2015Unraveled Material

    (B)(6) 2015 REPORTEDLY, DOCTOR INSERTED GUIDEWIRE INTO VEIN AND START PUSHING THROUGH. UNDER FLUOROSCOPY HE FOUND THAT THE GUIDEWIRE REACHED THE AUXILLIARY VEIN AND INSTEAD OF GOING FORWARD, MADE A U TURN. SUPPOSEDLY, HE THEN TRIED TO MANEUVER THE WIRE TO STRAIGHTEN IT BUT WAS NOT ABLE TO DO SO. REPORTEDLY, HE WAS NOT ABLE TO MANEUVER THE WIRE AND HE REALISED THAT THE WIRE WAS GETTING LONGER . HE KNEW THAT THE WIRE HAD ALLEGEDLY, UNRAVELLED AND INSERTED A COBRA CATHETER THROUGH THE GUIDEWIRE AND MANAGED TO GET THE GUIDEWIRE OUT THROUGH THE COBRA CATHETER .

    Patient problems: No Information

    MAUDE report 5269048 ↗

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

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Sources and updates

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