Poly RadPICC Catheter 3164155Recalls & reported problems

Bard Access Systems, Inc. · Poly RadPICC Catheter 4F Single-Lumen Polyurethane Catheter Microintroducer 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

Quick summary

This Bard Poly RadPICC catheter is a long-term central line placed through a vein in the arm. The 54 reports mostly describe the plastic securing clamp detaching, which let the catheter slide partway out of the vein, and one report mentions a break. No deaths or injuries were reported. There are no recalls for this device, and no reports were filed in the past year.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 54
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00801741034947), received between Aug 9, 2018 and Jan 28, 2023 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (54 reports).

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 or Device Component54
Break1

Patient problems

No Clinical Signs, Symptoms or Conditions53
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261353 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." ON 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE THIRTY SIXTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261349 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE TWENTY NINETH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261344 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY FIFTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261343 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE TWENTY SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261338 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM.". 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE THIRTY EIGHTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261337 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FIFTEENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261334 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE THIRTY FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261333 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE EIGHTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261329 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE TWENTY FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261328 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY EIGHTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261323 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE SEVENTEENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261322 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261321 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE TENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261319 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY SIXTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261318 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." 1/27/2023: FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261317 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY NINTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261316 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY SEVENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261315 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE THIRTY FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261314 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE THIRTY NINTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261312 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE THIRTY SEVENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261311 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM. ON 1/27/2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTY SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261310 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE FORTIETH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261308 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE TWENTY SEVENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261307 ↗
MalfunctionJan 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER "THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." (B)(6) 2023 - FORTY-NINE DEVICES WERE RETURNED FOR EVALUATION AND ALL EXHIBITED DETACHMENT. THIS REPORT ADDRESSES THE THIRTY SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261305 ↗

Device details

UDI-DI	`00801741034947`
Brand	Poly RadPICC Catheter
Model	3164155
Company	Bard Access Systems, Inc.
Product code	LJS · Catheter,intravascular,therapeutic,long-term greater than 30 days
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 19, 2021

Device type (GMDN): Peripherally-inserted central venous catheter

A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page