PowerPICC SOLO 1194108D2Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741154881), received between Aug 7, 2019 and Aug 31, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Material Deformation

  It was reported by the customer that the wire kept bending very badly. When removed a kink and noted to the tip of the wire. No patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525221 ↗
• MalfunctionApr 21, 2026Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS DIFFICULTY WITH INTRODUCER. UPON INSPECTION, DAMAGE SEEN ON THE GRAY PIECE OF THE INTRODUCER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24946845 ↗
• MalfunctionJun 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THAT PICC REMOVED DUE TO LEAKING, DAMAGE AT 5 CM MARK. THE LEAK OCCURRED INTERNAL TO THE PATIENT. THE PATIENT COMPLAINED OF BURNING DURING ANTIBIOTIC INFUSION. NO INTERVENTION REQUIRED BUT CAUSED A DELAY IN TREATMENT.

  Patient problems: Burning Sensation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358235 ↗
• MalfunctionJun 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BROKEN PICC AT 12 CM MARK, DISCOVERED BECAUSE OF LEAKING. PLACED (B)(6), REMOVED (B)(6). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22248453 ↗
• MalfunctionJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT CAME IN TO HOSPITAL ON 5/21 BECAUSE PICC WAS NOT GIVEN BLOOD RETURN. VAT THEN CHANGED DRESSING AND NEEDLESS CONNECTOR AND WAS ABLE TO ESTABLISH BLOOD RETURN. ON 5/22, HOME HEALTH NURSE FLUSHED THE LINE AND THERE WAS LEAKING AT THE INSERTION SITE. PATIENT CAME INTO HOSPITAL TO HAVE VAT EVALUATE AND THEY REMOVED THE LINE, AND NOTICED IT WAS DAMAGED. NO PATIENT INJURY AT THIS TIME. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171012 ↗
• MalfunctionMar 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER PICC WAS ORIGINALLY PLACED IN THE PATIENT'S RIGHT BASILIC VEIN ON (B)(6) 2025. CATHETER WAS TRIMMED TO 44CM AND 3CM EXTERNAL WAS OUT ON DAY OF INSERTION. PATIENT IS RECEIVING IV ANTIBIOTICS AT HOME. HAS DRESSING CHANGES DONE WITH BLOOD DRAWS ONCE A WEEK IN INFUSION CENTER. PATIENT SEND TO OUTPATIENT INFUSION CENTER BY RN WITH COMPLAINTS OF LEAKING AT PICC INSERTION SITE. ARRIVED TO PATIENT'S ROOM AND DRESSING IS SATURATED WITH PINK TINGED, CLEAR DRAINAGE. ARM DOES NOT APPEAR SWOLLEN AND PATIENT DECLINES PAIN-MEASURED ARM CIRCUMFERENCE AND IT IS 27CM WHICH IS THE SAME MEASUREMENT PRIOR TO PICC INSERTION. FLUSHED LINE AND WAS ABLE TO HEAR AUDIBLE BUBBLING ALONG WITH VISUALIZED LEAKING. REMOVED DRESSING-LEAKING COME FROM HORIZONTAL SPLITS (X2) IN PICC LINE. LINE REMOVED; VASELINE GAUZE DRESSING APPLIED. ORDER RECEIVED BY DR. TO REPLACE PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21624002 ↗
• MalfunctionFeb 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED LINE WAS PLACED ON 1/1. ON 1/14 IT WAS REPORTED THAT THE PICC WAS LOOPED IN THE SUBCLAVIAN. NO PICC LINE WAS PLACED DUE TO THE RN UNABLE TO REPOSITION THE LINE. NEW LINE WAS PLACED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363651 ↗
• MalfunctionJan 31, 2025Material Frayed; Material Frayed

  "IT WAS REPORTED IT APPEARED THAT THE WIRE WAS MISSING THE COPPERY TIP. NO OTHER INFORMATION WAS PROVIDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286361 ↗
• MalfunctionJan 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THEY WENT TO REMOVE THE WIRE FROM THE PICC KIT, THE TIP OF THE WIRE WAS BENT IN THE PACKAGING. THE KIT WAS DISPOSED, AND A NEW KIT HAD TO BE USED. NO OTHER INFORMATION WAS PROVIDED. ON 12/12/2024: THE RETURNED DEVICE EXHIBITED A BENT STYLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117842 ↗
• MalfunctionDec 30, 2024Break; Misconnection; Break; Misconnection

  IT WAS REPORTED BY THE CUSTOMER, A PATIENT IN OUR FACILITY HAD A VALVED SL PICC PLACED ON 11/22. 12/4, THE BEDSIDE NURSE ENTERED THE ROOM AND FOUND THAT THE VALVE HAD SEPARATED FROM THE PICC. BEDSIDE NURSE REPORTS THAT THE DRESSING AND STATLOCK WERE INTACT. NEW PICC HAD TO BE INSERTED. ADDITIONAL INFORMATION RECEIVED 12/18/2024: IT WAS REPORTED THERE WAS NO INJURY TO THE PATIENT, LEAKED MAINTENANCE FLUIDS BUT NO BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035584 ↗
• MalfunctionNov 6, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT WHEN I PEELED THE PEEL-A-WAY SHEATH, IT LEFT A RING OF PLASTIC AROUND THE PICC. IT WAS VERY DIFFICULT TO REMOVE. I ENDED UP JUST MAN HANDLING IT, AS I WAS AFRAID TO USE A SHARP INSTRUMENT. THERE WAS NO REAL IMPACT TO THE PATIENT, AFTER THE "RING" WAS RELEASED, THE PICC WAS FINE. IT WAS DIFFICULT FOR ME TO RELEASE THAT "RING", AND MAY HAVE DELAYED THE PROCEDURE FOR A FEW MINUTES, BUT THE PATIENT WAS FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622100 ↗
• MalfunctionNov 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PATIENT CAME IN FOR AN INFUSION AND THE DEVICE WAS LEAKING AT INSERTION SITE WHEN FLUSHED. THIS WAS PULLED AND THERE WAS A LARGE HOLE DOWN THE CATHETER. PICC LINE PLACED ON (B)(6) 2024 WITH LOT NUMBER REJR0470. PATIENT CONTINUED TO RECEIVE IV ANTIBIOTICS. ON (B)(6) 2024 DURING ANTIBIOTIC INFUSION PICC DRESSING NOTED TO BE WET WITH LEAKING FLUID AND SOME BLOOD. DRESSING CHANGED, AND PICC LINE NOT USED. ON (B)(6) 2024 PICC LINE PULLED AND SHEAR NOTED IN PICC LINE EXTENDING APPROXIMATELY HALFWAY THROUGH DIAMETER OF PICC LINE IN AREA TUNNELED UNDER SKIN. DELAY OF ANTIBIOTICS WHILE WAITING ON PICC LINE, AND INABILITY TO PLACE ANOTHER PICC LINE DUE TO INFECTION RISK, NECESSITATING PATIENT TO BE STUCK DAILY X6 TO COMPLETE ANTIBIOTIC REGIMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588227 ↗
• MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PATIENT CAME IN FOR AN INFUSION AND THE DEVICE WAS LEAKING AT INSERTION SITE WHEN FLUSHED. THIS WAS PULLED AND THERE WAS A PIN HOLE 2-3 CM DONE. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION 10/07/2024: PICC LINE PLACED ON (B)(6) 2024 FOR DAILY IV ANTIBIOTICS. LOT NUMBER REJR0470. ON (B)(6) NOTED BLOOD AND FLUID LEAKING AROUND PICC INSERTION SITE. INR NOTED TO BE 6.1, PATIENT WAS ADMITTED FOR OBSERVATION. PICC PULLED ON (B)(6) 2024. AFTER PULLING PICC LINE, PICC NURSE FLUSHED PULLED PICC LINE WITH SALINE TO DISCOVER A "PINPOINT" LEAK IN THE TUBING IN SECTION WHERE PICC WAS TUNNELED IN ARM. REPLACEMENT OF PICC LINE AND DELAY OF ANTIBIOTICS WHILE WAITING ON PICC LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568833 ↗
• MalfunctionSep 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC LINE WAS LEAKING. AFTER INVESTIGATION, FOUND A HOLE AT THE 3.5CM MARK. THE PATIENT WAS DIRECTLY INVOLVED, THE PICC HAD TO BE REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311874 ↗
• InjurySep 6, 2024Break; Break

  IT WAS REPORTED THAT THE COMPLETE BREAK OF THE CATHETER WITH RETENTION OF 39CM OF CATHETER. THE RETAINED PIECE OF LINE WAS RETRIEVED VIA CUT DOWN IN IR. LINE HAD A SECURACATH SECUREMENT DEVICE. LINE FAILURE POINT WAS BETWEEN THE 6 AND 7 CM MARKERS ON THE LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20157353 ↗
• MalfunctionJul 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT 3FR SL PICC PLACED AT 0CM LEFT OUT ON 5/11 WITH NO DIFFICULTY. PATIENT WENT HOME WITH THE PICC AND PRESENTED AT THE ER WITH A LEAKING PICC ON 6/15 WITH 5CM OF THE PICC OUT OF THE INSERTION SITE. A SECUROCRAT WAS PLACED AT THE EXIT. 6/16 PICC WAS STILL LEAKING AND WAS PULLED. UPON INVESTIGATION A HOLE WAS OBSERVED AT 8CM. PATIENT SAYS HOME HEALTH NEVER USED SCISSORS TO CHANGE DRESSING. PATIENT HAD TO GO TO THE ER, PATIENT RECEIVED ANOTHER VASCULAR ACCESS DEVICE. THERE WAS NO SERIOUS INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767501 ↗
• MalfunctionApr 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, ¿PICC INSERTED (B)(6) 2024. STARTED LEAKING ON FRIDAY, (B)(6) 2024, AND WAS REMOVED SATURDAY, (B)(6) 2024. CRACK NOTED IN LINE AT THE 4MM MARK AND WAS DIFFICULT TO REMOVE. NO ILL EFFECTS TO PATIENT, NEW PICC INSERTED (B)(6) 2024.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028450 ↗
• MalfunctionApr 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, ¿PICC LINE PLACED 12/28/2023, IN USE FOR 10 WEEKS. PATIENT HAD THE LINE FOR HOME ANTIBIOTICS. SHE STARTED FEELING PAIN WITH INFUSION LAST NIGHT, SO WE PULLED AND REPLACED THE LINE TODAY AND NOTED A FRACTURE IN THE PICC AT THE 9CM MARK. PATIENT HAD HER ANTIBIOTIC INFILTRATE INTO HER ARM SO MISSED ONE DOSE, HAD TO GO THROUGH ANOTHER PICC INSERTION.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 19010794 ↗
• MalfunctionJan 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER REPORTED A PICC LINE THAT WAS PLACED THAT HAS BEEN LEAKING FOR A FEW DAYS. VAT TEAM WENT TO ASSESS THE LINE AND APPEARED IT WAS LEAKING, SO THE PICC WAS REMOVED. RN FLUSHED THE LINE AND SPLIT WAS NOTED NEAR THE 5 CM MARK. ADDITIONAL INFORMATION RECEIVED 12/13/2023: THE LEAKING WAS NOTED WHILE IN THE PATIENTS ARM BUT NO INJURY WAS NOTED OR REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440427 ↗
• MalfunctionDec 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER PICC PULLED OUT OF PATIENT AND HAD A TEAR NEAR THE 5CM MARK. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410747 ↗
• MalfunctionMay 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH, PICC WAS MALFUNCTIONING, ONCE REMOVED, THERE WAS BREAK BETWEEN THE 5-6CM MARK ON THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882443 ↗
• MalfunctionApr 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "PICC LEAKING AT INSERTION SITE. THE NURSES STATED THE ARM LOOKED SLIGHTLY SWOLLEN IN THE MORNING SO THEY ORDERED A VASCULAR ULTRASOUND TO EVALUATE FOR A CLOT. THE ULTRASOUND WAS NEGATIVE. THE NURSE EVALUATED THE PATIENT AND FELT THERE MAY BE A BREAK IN THE PICC. ADDITIONAL INFORMATION RECEIVED ON 4/17/2023: IT WAS REPORTED BY THE CUSTOMER "PICC WAS REPORTED TO BE LEAKING AT SITE. WHEN FURTHER EVALUATED AFTER DISCONTINUING PICC FROM PATIENT, IT WAS NOTED TO HAVE A BREAK IN THE PICC AT 5/6 CM MARK."

  Patient problems: Swelling/ Edema

  MAUDE report 16792213 ↗
• MalfunctionApr 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "I HAVE A CATHETER THAT I PULLED TODAY THAT WAS DAMAGED. THE PICC WAS LEAKING SIGNIFICANTLY WHEN IT WAS FLUSHED. THE PT REPORTS THAT THIS DID NOT HAPPEN THE DAY BEFORE. I IMMEDIATELY REMOVED THE LINE AND THERE IS A HORIZONTAL CRACK AT THE 6 CM MARK. THIS [PICC PLACEMENT] WOULD NOT HAVE BEEN IN ANY AREA WITH A SIGNIFICANT BEND SUCH AS THE ARM PIT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111899 ↗
• MalfunctionNov 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ONE OF THE PICC NURSES HERE PULLED A PICC LINE ON 10/20 THAT WAS CRACKED BETWEEN 6-7 CM LINE POSSIBLY WHILE INSIDE OF THE PATIENT. IT WAS PLACED ON 5/19/21."NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783284 ↗
• MalfunctionJun 16, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "PICC STYLET BROKEN IN MULTIPLE PLACES." ADD INFO RCVD 06/02/2021: PLACEMENT INFO: SUCCESSFUL LINE PLACEMENT. 3CG WIRE REMOVED AND AS I WAS GOING TO PLACE NEUTRON ON END OF PICC A WIRE WAS HANGING (UNATTACHED) FROM INSIDE PICC LINE. I WAS ABLE TO GRAB WHAT I THOUGHT WAS ALL OF IT, PLACE A TOURNIQUET AND REMOVE LINE. ONCE LINE WAS REMOVED THE WIRE WAS FROM UNDERNEATH SHEATH IN SENSOR AREA. WIRE WAS MISSING BUT SHEATH STILL IN PLACE. WAS THERE PATIENT HARM REPORTED?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009148 ↗