PowerPICC CK000613Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741121395), received between Sep 26, 2023 and Sep 15, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

2 FDA recall records name this device's identifier, 2 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. May 21, 2026Open, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776464 ↗
• MalfunctionMar 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT A PICC CATHETER WHICH AFTER PLACEMENT WAS LEAKING AND WAS FOUND TO BE CRACKED UPON REMOVAL. THE ORIGINAL PICC PLACEMENT WAS PERFORMED ON (B)(6) 2024. THE PICC WAS LEAKING ON (B)(6) 2024 THE PICC LINE WAS REMOVED AND REPLACED. NO OTHER ADVERSE EVENTS. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED: THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. PATIENT HAD A LEAKING PICC FOR SEVERAL DAYS; THE PICC CATHETER NEEDED TO BE REMOVED AND REPLACED. NO OTHER ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18850227 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, ON 01-03-2024 TOLEDO HOSPITAL BD PICC WAS PLACED, AND THE PATIENT BECAME ANXIOUS AND SHORT OF BREATH. PATIENT CODE BLUE. NOW RECOVERED AND STABLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Anxiety; Dyspnea

  MAUDE report 18540109 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, ON 01-01-2024 TOLEDO HOSPITAL BD PICC WAS PLACED, AND RAPID RESPONSE WAS CALLED - THE PATIENT EXPERIENCED LIP TINGLING AND SHORTNESS OF BREATH. PICC WAS REMOVED IMMEDIATELY, AND NO FURTHER ISSUES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 18537118 ↗
• MalfunctionSep 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD REMOVED A PICC FROM A PATIENT YESTERDAY. THEY STATED THAT THEY WERE IN THE ED THE DAY PRIOR, AFTER FEELING A POP IN THE LINE AND PATIENT REPORTS FEELING FLUID INSIDE HER ARM. LINE WAS INTACT UPON REMOVAL BUT THERE IS AN OBVIOUS HOLE THAT IS ALMOST SEVERING THE LINE BETWEEN THE 8CM AND 9 CM MARKS. THIS HAPPENED AS PATIENT WAS FLUSHING THE LINE, THEY WENT TO THE ED AND WERE TOLD IT FLUSHES FINE, THEY WOULD BE OK UNTIL APPT TOMORROW (9/8). ONLY SALINE WAS FLUSHED AFTER POP. TO MY KNOWLEDGE, NO LINE WAS RETAINED WITHIN THE PATIENT. INSERTION NOTE STATES 38CM, AND 38CM WAS REMOVED. PATIENT WAS ON DAPTOMYCIN FOR TREATMENT WHEN THIS OCCURRED. THERE WAS A STATLOCK IN PLACE AS WELL AS A TEGADERM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821287 ↗