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PowerPICC CK000796Recalls & reported problems

Bard Access Systems, Inc. · Catheter Placement Kit · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741144783), received between Jun 14, 2023 and Jun 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

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 · FDA record ↗

Most reported problems

Device problems

  • Fluid/Blood Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY THE CUSTOMER THAT PULLED A BARD PICC CATHETER CUSTOMER PLACED WITH A TEAR AT ABOUT THE 5CM MARK AFTER 1 WEEK OF USE. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFO RECEIVED ON 16-JUNE-23: IT WAS REPORTED BY THE CUSTOMER "PATIENT IS RECEIVING 6 WEEKS OF ANTIBIOTICS. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE-THREATENING MEDICAL SITUATION. THE CATHETER TEAR WAS DISCOVERED UPON REMOVAL DUE TO LEAKING AND PAIN AT THE SITE OF THE CATHETER TEAR. THIS CAUSED A DELAY IN TREATMENT FOR 3 DAYS. CATHETER WAS SECURED WITH STATLOCK. PATIENT REQUIRED A TUNNELED IJ CATHETER BECAUSE PERIPHERAL VENOUS DEPLETION. DATE OF EVENT WAS 17 DAYS AFTER INSERTION".

    Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

    MAUDE report 17131003 ↗

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

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.