PowerPICC Provena CK000954ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741223310), received between Aug 22, 2023 and Apr 14, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Product Quality Problem

  IT WAS REPORTED THAT WHEN ATTEMPTING TO SEPARATE THE T-LOCK FROM THE RUBBER BAND THE ENTIRE T-LOCK BROKE OFF FROM THE WIRE WITH ABSOLUTELY NO EFFORT WHAT SO EVER. I WAS HOLDING ONTO THE YELLOW TAB AS INSTRUCTED BY BARD FOR BEST PRACTICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872539 ↗
• MalfunctionAug 22, 2023Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  IT WAS REPORTED BY CUSTOMER THAT DURING DUAL LUMEN PICC PROCEDURE, THE PORT WITH THE STYLET WAS HAVING RESISTANCE WHEN FLUSHING, AND THEN STARTED LEAKING FROM THE GREEN LUER LOCK SIDE PORT BETWEEN THE GREEN HUB AND THE CLEAR PLASTIC TUBING. APPEARS TO HAVE A NARROWING OF THE TUBING WITHIN THE CONNECTION OF THE HUB AND CLEAR TUBING. NO PATIENT HARM OR IMPACT. PICC INSERTER NOTICED LEAK BEFORE INSERTION SO NEW PICC KIT WAS OPENED, AND NO LEAKAGE OR DEFECT WAS NOTED FROM THE SECOND KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596674 ↗