PowerPICC CK000631BRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741143748), received between Dec 12, 2018 and Jan 30, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Fluid/Blood Leak

  IT WAS REPORTED, PICC LEAKING THE DAY AFTER INSERTION. NURSE FOUND THAT THE LINE WAS FRACTURED. ADDITIONAL INFORMATION RECEIVED 23-JAN-2026: THE IMPACT TO THE PATIENT WAS AN UNNECESSARY LINE REMOVAL AND REPLACEMENT WITHIN 12 HOURS OF THE ORIGINAL INSERTION. NORMAL SALINE WAS INFUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221728 ↗
• MalfunctionOct 16, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED BY A CUSTOMER THAT THEY HAD AN ISSUE WITH PEEL AWAY SHEATHS THIS WEEK ON THE NOTED LOT NUMBER AND THE MOUTH OF THE SHEATH DIDN'T SEPARATE COMPLETELY. I WAS ABLE TO SALVAGE THE LINE ON ONE OCCASION SO THERE ISN'T A SECOND KIT NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316535 ↗
• MalfunctionJul 17, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED, PATIENT WITH A LINE ISSUE THAT THE PATIENT HAD PLACED ON (B)(6) IT WAS A SINGLE LUMEN FOR AT HOME THERAPY. THE PATIENT STATES THAT HE WAS DISCHARGED HOME WITHOUT ISSUES. WITHIN A COUPLE WEEKS HE WAS HAVING ISSUES WITH INFUSIONS FLOWING SO HE WAS SEEN AT THE INFUSION CLINIC. THE NURSE DID SOME INTERVENTIONS AND GOT THE LINE WORKING AGAIN AND ON THE MORNING OF (B)(6), PATIENT WOKE UP AROUND 0100 WITH SOME TENDERNESS TO THE ARM AND COLD TO TOUCH, THE PATIENT AND HIS FAMILY ALSO STATES THAT THE LINE WAS LEAKING AT THE SITE. HE THEN WENT TO THE EMERGENCY DEPARTMENT TO BE EVALUATED WHERE THE TEAM WAS EVENTUALLY NOTIFIED AND SENT A VAST NURSE ON THE MORNING OF (B)(6). UPON ASSESSMENT THE PATIENT HAD A VISIBLE KINK IN THE UPPER ARM AREA UPON X-RAY THE LINE WAS PULLED AND NOTED TO HAVE A PIN SIZE WHOLE AND NUMBER MARKS HAVE WORN OFF. THE LINE WAS REMOVED. THE PATIENT HAD ANOTHER PICC PLACED AND NO HARM WAS NOTED.

  Patient problems: Pain

  MAUDE report 22531130 ↗
• MalfunctionMay 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, (B)(6) 2025 PICC PLACED, NO ISSUES ON CATHETER ASSESSMENT/INSPECTION. (B)(6) 2024 NOTIFIED HOLE IN PICC. CLEAR LUMEN WITH 2 HORIZONTAL BREAKS ALONG SEAM. BOTH WITH BLOOD LEAKING THROUGH. PICC REMOVED AND NEW PICC PLACED. PATIENT AND CARE GIVERS ADAMANTLY DENY HAVING/USING ANY SHARP ITEMS NEAR PICC. CAREGIVER/SPOUSE REPORTED MULTIPLE TIMES TETRANET SNAGGED AND GOT CAUGHT INSIDE THE CLAMP ON SOMETHING. HAD TO HAVE A HOME HEALTH NURSE VISIT TO FIX IT. PATIENT HAD TO RETURN TO HOSPITAL FOR PICC REMOVAL, NEW PICC PLACEMENT AND CONFIRMATION X-RAY WITHIN 48 HOURS OF DISCHARGE FROM INPATIENT STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044209 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDWATCH PATIENT NOTED PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS LEAKING/BLEEDING. TWO HORIZONTAL SLITS IN CLEAR TUBING 0.5-1CM APART. BLOOD BACKING UP INTO PICC BLEEDING FROM SLITS. REQUIRED PICC REMOVAL AND NEW PICC PLACEMENT. INCREASED MONITORING FOR BACTEREMIA RECOMMENDED. NEEDED X-RAY FOR NEW PICC DUE TO ATRIAL FIBRILLATION (A-FIB). ON HOME ADMINISTERED IV ANTIBIOTICS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22040437 ↗
• MalfunctionMar 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT DESCRIBED AN INABILITY TO INFUSE IVF AS ORDERED. RN VISITED PATIENT AND NOTICED LEAKING AT THE INSERTION SITE. THE RN THEN PULLED BACK CATHETER 1CM AND FLUSHED AGAIN NOTING THE FLUID LEAKING OUT OF THE CATHETER VIA THE SUBCUTANEOUS HOLE. LINE PULLED FOR SAFETY. PATIENT DECLINED ADDITIONAL VASCULAR ACCESS WANTING TO TRY ORAL HYDRATION, NEAR END OF PREGNANCY AND FEELING GOOD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692640 ↗
• MalfunctionMar 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THEY WERE UNABLE TO INFUSE OR FLUSH AND UPON NURSE VISIT, THE PICC WAS LEAKING AT THE INSERTION SITE, WHICH SHOWED A HOLE IN THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692630 ↗
• MalfunctionSep 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY RECENTLY HAD TO REPLACE A PICC LINE FOR A PATIENT THAT APPEARED TO BE DAMAGED IN AN AREA THAT WOULD NOT NECESSARILY BE AFFECTED DURING PLACEMENT. IT WAS PLACED ON JULY 9TH AND REMOVED ON (B)(6) AFTER WE WERE CALLED TO ASSESS THE LINE FOR ISSUES. PATIENT SUFFERED DISCOMFORT. LINE LEAKED NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20267453 ↗
• MalfunctionJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WE HAD TO REPLACE A PICC LINE FOR A PATIENT THAT APPEARED TO BE DAMAGED IN AN AREA THAT WOULD NOT NECESSARILY BE AFFECTED DURING PLACEMENT. IT WAS PLACED ON APRIL 17TH AND REMOVED ON MAY 17TH AFTER WE WERE CALLED TO ASSESS THE LINE FOR ISSUES. DAMAGE TO LINE WAS DETERMINED ONCE REMOVED." NO PATIENT HARM WAS REPORTED, NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525305 ↗
• MalfunctionOct 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED: LINE SEEMS TO BE LEAKING. PATIENT WAS RECEIVING INFUSIONS AT OUTPATIENT CLINIC WHICH REPORTED LINE WOULD LEAK DURING INFUSION. LOCATION: RIGHT UPPER EXTREMITY. LENGTH: 39 CM. YES USED ON A PATIENT, NO HARM DONE. LOWER ABD WOUND. STAT LOCK SECUREMENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698566 ↗
• MalfunctionJun 30, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "CLINICIAN REMOVED A PICC TODAY ON A PATIENT AND A SECTION OF IT WAS BALLOONED OUT... IT WAS A SINGLE LUMEN, LOT # REFV2272, EXP (B)(6) 2022, AND WAS PLACED ON (B)(6) 2022. . .TODAY THE LINE WAS EXCHANGED OVER THE WIRE PURELY BECAUSE THE PATIENT NEEDED MORE ACCESS THAN THE SINGLE LUMEN. WHEN REMOVED, THERE WAS NO RESISTANCE, IT'S COMPLETELY INTACT, INITIALLY SHE THOUGHT IT WAS A FIBRIN SHEATH BUT ON CLOSER INSPECTION OBVIOUSLY NOT. SHE DOES HAVE THE CATHETER TO INSPECT IT. TOTAL LENGTH WAS 44CM AND THE BALLOONED AREA IS BETWEEN THE 35CM AND 37CM MARKS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876027 ↗
• MalfunctionJun 30, 2021Activation Problem; Activation Problem

  IT WAS REPORTED NEEDLE IN 4 FR POWER PICC DIDN'T SAFETY. PLASTIC PIECE OF THE SAFETY SLID OFF BUT THE SAFETY DEVICE WAS STILL AT THE TOP LEAVING THE USED NEEDLE EXPOSED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093674 ↗
• MalfunctionNov 25, 2020Break

  IT WAS REPORTED THAT PROBE COVER WAS REMOVED FROM THE PACKAGING AND HAD A SLIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10906898 ↗
• MalfunctionDec 12, 2018Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PICC SPLIT AT THE HUB/CATHETER CONNECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155214 ↗