PowerPICC Provena CK000988Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741216022), received between Oct 26, 2023 and Sep 5, 2025 — classified as 1 injury, 4 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 18, 2026.

Recalls naming this device

1. May 21, 2026Class IIOpen, 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 · Recall details · 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 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC WAS LEAKING AND BLEEDING. INSERTED PICC IN PATIENT ON (B)(6) 2025. AFTER HAVING A PROCEDURE, PACU NOTIFIED THE MANAGER THAT THE PATIENT'S PICC WAS LEAKING AND BLEEDING. WAS ABLE TO SEE THAT THE PICC WAS FRACTURED 2CM PAST THE INSERTION SITE WHERE IT HAD KINKED. PATIENT WAS RECEIVING ANTIBIOTIC THERAPY. PATIENT HAD TO BE STUCK AGAIN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22979987 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Device Markings/Labelling Problem; Fluid/Blood Leak; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE CUSTOMER, NURSE WAS CUTTING THE PICC TO INSERT WHEN SHE NOTICED A POTENTIAL CUT OR MARK ON THE PICC 3.5CM UP FROM THE CUT. SHE DID NOT INSERT THE PICC AND GOT A NEW ONE TO INSERT. ADDITIONAL INFORMATION RECEIVED 01/29/2025: IT WAS REPORTED BY THE CUSTOMER, "NOT SURE IF IT WAS A CUT OR A MARK BUT THE PICC IS IN ONE PIECE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411485 ↗
• MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, KINKING OF THE CATHETER NOTED ON CXR. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT THERE WERE 2 FRACTURES IN THE PICC LINE WHERE THE CATHETER WAS KINKED. THIS WAS APPROXIMATELY MIDWAY OF THE LENGTH OF THE CUT CATHETER (35 CM). PATIENT HAD TO BE STUCK AGAIN. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118698 ↗
• MalfunctionApr 18, 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 19135065 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT REMOVING THE STATLOCK DURING A DRESSING CHANGE, THE PATIENT'S SKIN CAME OFF IN A PERFECT OUTLINE OF WHERE THE PICC STAT-LOCK WAS LOCATED. NURSE DID NOT RE-APPLY A STATLOCK WHEN THEY SECURED THE PICC AGAIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Skin Tears

  MAUDE report 18014072 ↗