PowerPICC CK000513ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741110030), received between Nov 30, 2021 and Dec 4, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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

Recent adverse event reports

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

• MalfunctionDec 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED WHEN GETTING READY TO INSERT A SINGLE LUMEN 4 FR POWERPICC IT ALMOST FEELS LIKE SOMETHING MELTED ONTO THE CATHETER. WHEN YOU RUB YOUR FINGER OVER IT, IT¿S A ROUGH FEELING. A NEW KIT WAS OPENED TO COMPLETE PICC INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716654 ↗
• MalfunctionNov 18, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED PLUNGER ON T-LOCK EXTENSION FOR PICC STYLET CAME OUT OF HOUSING DURING INSERTION/FLUSHING. NO PATIENT OR USER IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585509 ↗
• MalfunctionNov 30, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED VIA MS&S "CALLER REQUESTING BD RECOMMENDATIONS ON CLAMPING HER DAD'S POWERPICC (REF (B)(4), LOT#REFR0398). STATES THE LAST AGENCY NURSE THAT CHANGED HER DAD'S PICC DRESSING AND NEEDLELESS CONNECTORS DID NOT CLAMP HIS POWERPICC AND NOW HIS LINE IS CLOTTED. SHE WANTS TO NOW IF THE NURSE ACTIONS CAUSED HIS PICC TO BE OCCLUDED BECAUSE SHE NOW HAS TO PAY FOR CATHFLO TO GET IT WORKING AGAIN. THEY NEVER HAD ANY ISSUES FOR MONTHS UNTIL RECENTLY. MS&S EXPLAINED THE POWERPICC DEVICE IS A NON-VALVED PICC. THE CLAMPS ARE SAFETY FEATURES THAT HELP PREVENT AIR EMBOLISM AND BLEEDING IN CASE THE NEEDLELESS CONNECTOR BECOMES DISCONNECTED FROM THE LINE. WE WOULD RECOMMEND THE LUMENS BE CLAMPED BETWEEN EACH USE FOLLOWING THE GUIDELINES OF THE NEEDLELESS CONNECTORS ON HER DAD'S POWERPICC. EXPLAINED SOME POSSIBLE CAUSES OF HIS PICC OCCLUSION. CUSTOMER STATES SHE IS NOT SURE IF HIS CATHETER IS BEING FLUSHED WITH SALINE AND HEPARIN AS RECOMMENDED. EXPLAINED TO MAKE SURE THE PHYSICIAN IS AWARE OF THE OCCLUSION AND NURSING STAFF IS WELCOME TO CALL FOR INSTRUCTIONS AND BD'S RECOMMENDATIONS FOR HER DAD'S POWERPICC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12903857 ↗