PowerPICC SOLO CK000289CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741161148), received between Dec 22, 2020 and Dec 19, 2025 — classified as 5 malfunctions.

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

• MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT PRESENTED TO ED REPORTING LEAKING FROM INSERTION SITE OF PICC LINE. LINE WAS REMOVED AND EVALUATED BY VAS RN. FOUND TRANSVERSE FRACTURE AT 7CM MARK. PICC LINE REMOVED, REPLACED WITH MST MIDLINE TO FINISH REMAINDER OF IV ANTIBIOTICS TREATMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851348 ↗
• MalfunctionNov 10, 2025Material Frayed; Material Twisted/Bent; Material Frayed; Material Twisted/Bent

  IT WAS REPORTED THAT ON 10/20/2025, WHILE INSERTING A 4FR, SINGLE LUMEN PICC, I NOTICED THE SHERLOCK 3CG TIP CONFIRMATION COPPER TIP, WAS ABOUT HALF THE SIZE IT USUALLY IS. IT ALSO SEEMED BENT A BIT. I DID NOT CUT THIS TIP. THE WIRE WAS PULLED BACK QUITE A BIT, PRIOR TO TRIMMING, AS ALWAYS. I DID NOT INSERT THIS PICC BUT HAD TO OPEN ANOTHER KIT FOR A NEW PICC, SAME LOT # AND THE TIP WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512631 ↗
• MalfunctionJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT CRACKED PICC LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170564 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH, PICC LINE LEAKING AT THE INSERTION SITE. REMOVED AND INSPECTED. TRANSVERSE CRACK NOTED ALONG PICC LINE AT THE 6CM MARK. NEW PICC LINE WAS INSERTED FOR PATIENT TO CONTINUE IV THERAPY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964592 ↗
• MalfunctionDec 22, 2020Break; Material Twisted/Bent

  IT WAS REPORTED FAILED ATTEMPT ON PICC PLACEMENT AS THE 3CG WIRE WAS FOUND BENT/BROKEN AT THE DISTAL TIP. NO OTHER INFORMATION WAS PROVIDED. ON (B)(6) 2020-- DEVICE RETURNED FOR EVALUATION WAS FOUND KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11060954 ↗