PowerPICC SOLO2 Catheter 3295135Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741028106), received between Feb 17, 2017 and Sep 2, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Backflow” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573365 ↗
• MalfunctionSep 1, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543393 ↗
• InjuryFeb 18, 2026Product Quality Problem

  ADDITIONAL INFORMATION: AIR EMBOLISM WAS TREATED WITH HYPERBARIC OXYGEN THERAPY. IT IS UNKNOWN HOW MUCH AIR EMBOLIZED. PATIENT REPORTED RIGHT-SIDE WEAKNESS TO THE NURSE. NURSE ASSESSED THE PATIENT, GCS WAS E4M5V6, LIMB POWER OF RIGHT SIDE 2/5, LEFT SIDE 4/5, BILATERAL PUPIL SIZE 3MM, REACTIVE TO LIGHT. BLOOD PRESSURE: 101/72MMHG, PULSE: 89/MINUTES, SPO2: 94% IN ROOM AIR, TEMPERATURE: 36.6. PATIENT'S STATUS POST-TREATMENT WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: Air Embolism; Muscle Weakness/Atrophy

  MAUDE report 24378841 ↗
• MalfunctionMay 16, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER PICC LINE PLACED APRIL 10TH ISSUES DEVELOPED WHERE PICC LINE PORT COULD NOT BE USED, UNABLE TO FLUSH AND ASPIRATE FROM RED PORT. ALTAPLASE WAS PUT IN LINE BUT IT DID NOT CLEAR THE LINE. NO APPARENT HARM, INCONVENIENT. ADDITIONAL INFORMATION 09-MAY-2023 : THE PICCS WERE BEING USED FOR IV THERAPY INCLUDING FLUID, ANTIBIOTICS AND NUTRITION. THE STAFF WERE TRYING TO FLUSH THE PICCS AS PER PROTOCOL. WE ATTEMPTED TO DEAL WITH THE PICCS USING ALTEPLASE, ANTIBIOTICS AND NUTRITION HELD. CAUSED A DELAY IN ANTIBIOTIC THERAPY AND NUTRITION. THERE WERE NO FURTHER SURGERIES, TESTS EXCEPT FOR PICC LINES NEEDING TO BE RETHREADED AND/OR REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942700 ↗
• InjuryApr 15, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE POWERPICC SOLO CATHETER WAS PLACED ON (B)(6) 2022. THE GUIDEWIRE CANNOT BE ADVANCED SMOOTHLY AND THEN IT WAS FOUND KINKED IN PATIENT. THE GUIDEWIRE CANNOT BE REMOVED SO THE RADIOLOGIST FORCEDLY REMOVED THE GUIDEWIRE FROM THE PEEL AWAY SHEATH INTRODUCER. PART OF GUIDEWIRE WAS BROKEN AND REMAINED IN PATIENT¿S BODY. THE REMAINING GUIDEWIRE WAS REMOVED UNDER USG. PATIENT STATUS/ INTERVENTION: THE PATIENTS HAVE SERIOUS SVC STENOSIS (OBSTRUCTION).

  Patient problems: Foreign Body In Patient

  MAUDE report 14117635 ↗
• MalfunctionApr 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE POWERPICC SOLO CATHETER WAS PLACED SMOOTHLY ON (B)(6) 2022. BUT THE CATHETER WAS FOUND KINKED WHEN REMOVED FROM PATIENT. PATIENT STATUS/ INTERVENTION: NO INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115676 ↗
• MalfunctionMay 7, 2020Material Deformation; Material Deformation

  THE GUIDEWIRE WAS FOUND BENT DURING INSERTION AT X-RAY IN MID (B)(6) 2020. (B)(6) 2020- RETURNED GUIDEWIRE IS KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10035607 ↗
• MalfunctionJul 3, 2019Flushing Problem

  IT WAS REPORTED THAT THE PICC WAS UNABLE TO BE FLUSHED FREELY ON BOTH LUMENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8759047 ↗
• MalfunctionFeb 17, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CATHETER "ACCIDENTALLY" SLIPPED OUT AND WAS REMOVED BY THE DOCTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6338913 ↗