PowerPICC CK000986Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741216008), received between Oct 7, 2022 and Mar 17, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS FRACTURED ABOUT 2-3CM FROM THE CATHETER HUB. PATIENT NEEDED FOR 4-6 WEEKS OF ANTIBIOTICS (ABX) THERAPY AND LINE HAD TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21625390 ↗
• MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC TEAM WENT TO ASSESS A 4FR SL LINE AND FOUND A FRACTURE AROUND THE 5CM MARK. MEDICATION LEAKING IN VESSEL. IT IS UNKNOWN IF ANY HARM WAS CAUSED. PATIENT HAD TO BE STUCK AGAIN, LINE HAD TO REMOVED AND REPLACED CAUSING DELAYS IN MEDICATION ADMINISTRATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547833 ↗
• MalfunctionNov 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PATIENT'S PICC WAS LEAKING AT THE INSERTION SITE OF A SINGLE LUMEN 4FR PICC. PATIENT WAS RECEIVING CHEMOTHERAPY THROUGH THE LINE. WHEN THEY PULLED THE PICC THEY NOTICED IT WAS FRACTURED 3 CM FROM THE HUB. THE VAT INSERTED THE LINE ON (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767765 ↗
• MalfunctionOct 11, 2024Activation Problem; Activation Problem

  IT WAS REPORTED NURSE INSERTED INTRODUCER FOR PICC PLACEMENT AND THE SAFETY WOULD NOT ACTIVATE ON THE INTRODUCER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433257 ↗
• MalfunctionMay 15, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED WHEN PLACING A PICC, THE CLINICIAN NOTICED AN UNIDENTIFIABLE SPECK ON THE END OF THE DEAD END CAP INSIDE THE STERILE KIT. NO PATIENT IMPACT REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319994 ↗
• MalfunctionApr 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT TRANSITION FROM THE PEEL AWAY SHEATH WILL ROLL UP ON TISSUE. IT SPLITS IT AND HAVE TO GET A NEW ONE. IT IS SOMETHING WITH THE TRANSITION THAT CATCHES. HAVE TO GO BACK IN AND KNICK A SECOND TIME TO TRY TO ADVANCE THE INTRODUCER. THERE WAS NO ADVERSE OUTCOME OR SERIOUS INJURY TO THE PATIENT OR HEALTHCARE PROVIDER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114953 ↗
• MalfunctionOct 7, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER VIA MEDWATCH THE "PICC LINE INSERTED UNABLE TO PASS, BEGAN TO PULL CATHETER OUT TO END PROCEDURE AND BEGIN TO MEET RESISTANCE AT 37 CM. MASSAGED MUSCLE AND INJECTED REST OF LIDOCAINE TO AREA. CONTINUED TO MASSAGE AREA AND LINE WAS THEN ABLE TO BECOME DISLODGED AND A POP SOUND. AT THE END OF THE TIP WAS A SMALL KNOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15564369 ↗