PowerPICC SOLO2 Catheter 3295355Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741028144), received between Aug 24, 2016 and Jan 7, 2026 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (4 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Backflow

  ADDITIONAL INFORMATION: THE VALVE WAS NOT CLOSING PROPERLY DURING INSERTION. THE CATHETER WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993072 ↗
• MalfunctionMay 21, 2025Material Frayed; Material Frayed

  IT WAS REPORTED, DURING THE PREPARATION FOR THE INSERTION OF A PICC LINE, THE DOCTOR INSERTED THE NEEDLE AND THEN THE GUIDE WIRE. HALFWAY THROUGH, THE DOCTOR FELT RESISTANCE AND WITHDREW THE GUIDEWIRE BY ABOUT 5 CM, THEN MADE A SECOND ATTEMPT WITHOUT SUCCESS. WHEN HE WITHDREW THE GUIDEWIRE FOR THE SECOND TIME, THE GUIDEWIRE WAS FRAYED AND THERE WERE FILAMENTS COMING OUT OF IT. A SECOND DOCTOR WAS CALLED, AND THEY COMPLETELY REMOVED THE GUIDEWIRE. AN X-RAY WAS DONE TO ENSURE NO DEBRIS REMAINED INTERNALLY. THERE WAS AN IMPACT ON THE QUALITY OF CARE. ADDITIONALLY, THE PATIENT EXPERIENCED A LOT OF STRESS AND DID NOT RECEIVE A PICC LINE. FOLLOW-UP WAS CONDUCTED WITH THIS PATIENT, INCLUDING A PHYSICAL EXAMINATION, AN ULTRASOUND, AND MONITORING. ULTIMATELY, THERE WILL BE NO SHORT-TERM OR LONG-TERM CONSEQUENCES FOR THIS PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Distress

  MAUDE report 22066478 ↗
• MalfunctionMar 2, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THE PATIENT REQUESTING ASSISTANCE IDENTIFYING A 5CM CLEAR "SHEATH" ON THE OUTSIDE OF HER REMOVED POWERPICC SOLO CATHETER. STATES SHE IS IMMUNOCOMPROMISED AND HAS BEEN GETTING HER PICC REMOVED AND REPLACED EVERY 84 DAYS. STATES SHE IS ALSO AN EPIDEMIOLOGIST AND HAS BEEN RECEIVING IVIG INFUSIONS FOR MANY YEARS. SHE IS CONCERNED ON WHAT COULD BE ON THE OUTSIDE OF THE CATHETER AND IF IT DUE TO USER ERROR DURING PLACEMENT AS SHE HAS NEVER SEEN THIS BEFORE. HAS NO COMPLAINTS OR SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475498 ↗
• MalfunctionJan 28, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "THE TRANSITION ISN'T VERY SMOOTH WITH THE PEEL-AWAY SHEATH THAT COMES IN THE DUAL LUMEN 5F PICC KIT. IT DOES HAVE A SLIGHT STEP THAT HANGS UP ON THE VESSEL WALL OR FASCIA TO THE POINT THAT THE PROVIDERS NOW HAVE TO RUN THE DILATOR IN FIRST BY ITSELF AND THEN PUT IT BACK TOGETHER AND RE INSERT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261290 ↗
• MalfunctionMar 21, 2022Backflow; Backflow

  IT WAS REPORTED "CHEMO PATIENT. INFUSION HAD TO BE GIVEN THROUGH PIV SINCE BAG HAD ALREADY BEEN SPIKED AND PICC LINE WAS NOT PATENT. LINE WAS FLUSHED EARLIER THAT DAY AND WAS OK. LATER THE RN CAME BACK TO START BLOOD INFUSION. NOTICED THE PICC LUMEN HAD FILLED WITH BLOOD ALL THE WAY UP TO IT BEING VISIBLE IN THE EXTENSION LEG. RN STATED LINE HAD NOT BEEN USED SINCE LAST FLUSH." ADDITIONAL INFORMATION RECEIVED (B)(6) 2022: WHAT WAS INFUSION? NOTHING INFUSING ANY PATIENT SYMPTOMS RELATED TO THE EVENT? NO WAS THE CATHETER REMOVED? WAS A NEW CATHETER PLACED? NO WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STATLOCK "WE USE ALTEPLASE TO CLEAR CLOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839693 ↗
• MalfunctionMar 18, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED "PICC LINE WAS OCCLUDED AND ALTEPLASE WAS NEEDED TO RESOLVE. NO BLOOD DRAW HAD BEEN DONE RECENTLY." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13811269 ↗
• InjuryOct 2, 2020Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED THAT PART OF THE WIRE FROM ONE OF THE BARD PICC KITS BROKE OFF DURING A PICC PROCEDURE. THE WIRE WAS RETRIEVED ADDITIONAL INFORMATION RECEIVED 9/16/2020: IT WAS REPORTED THE PATIENT EXPERIENCED TEMPORARY HARM AS AN ADDITIONAL PROCEDURE WAS REQUIRED FOR THE FOREIGN BODY RETRIEVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 10620534 ↗
• MalfunctionFeb 7, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE GUIDEWIRE UNRAVELED IN PATIENT'S ARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9682570 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FACILITY IS HAVING ISSUES WITH CLOTTING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombus

  MAUDE report 9371549 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FACILITY IS HAVING ISSUES WITH CLOTTING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombus

  MAUDE report 9371546 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FACILITY IS HAVING ISSUES WITH CLOTTING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombus

  MAUDE report 9371545 ↗
• MalfunctionMar 28, 2018Crack

  IT WAS REPORTED THAT A PICC LINE THAT WAS REMOVED FROM PATIENT, APPEARED TO HAVE A CRACK IN THE TUBING. THIS PICC LINE WAS REMOVED AND A NEW ONE WAS REINSERTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7378993 ↗
• MalfunctionMar 2, 2018No Flow

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY HAS HAD TWO OCCURRENCE WHERE THEY WERE UNABLE TO FLUSH THE CATHETER. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT HARM REPORTED. THIS REPORTED ADDRESSES THE SECOND OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7310457 ↗
• MalfunctionMar 2, 2018No Flow

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY HAS HAD TWO OCCURRENCE WHERE THEY WERE UNABLE TO FLUSH THE CATHETER. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT HARM REPORTED. THIS REPORTED ADDRESSES THE FIRST OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7310428 ↗
• InjuryMay 18, 2017Device Dislodged or Dislocated

  IT WAS REPORTED ON 26-APR-17 THAT DISPLACEMENT OF THE PICC WITH POWER INJECTION AND VENOUS EROSION OCCURRED. THE PICC WAS INSERTED INTO THE LEFT BASILIC VEIN (B)(6) 2017, CUT AT 43 CM AND POSITIONED AT THE LEVEL OF SVC. POSITION WAS NORMAL AT THE TIME OF STUDY AND SUBSEQUENT CHEST XRAYS. A CT PULMONARY ANGIOGRAM WAS PERFORMED (B)(6) 2017 USING THE POWER PICC. THE SCOUT IMAGE IMMEDIATELY PRIOR TO INJECTION SHOWS THE PICC APPROPRIATELY POSITIONED. A POWER INJECTION AT LIKELY 4.5-5ML/SEC (OUR STANDARD PROTOCOL) WAS PERFORMED. THE CT IMAGES DEMONSTRATE THAT THE PICC HAS FLICKED UP INTO THE JUNCTION OF BRACHIOCEPHALIC VEIN AND SVC, CURLED INTO A LOOP. THIS WAS NOT NOTICED AT THE TIME, NOR ON SUBSEQUENT XRAYS. THE PATIENT DEVELOPED A SUBSEQUENT RIGHT EFFUSION AND AN INTERCOSTAL CATHETER INSERTED (B)(6) 2017. THE INTERCOSTAL CATHETER RETURNED TPN FLUID, WHICH THE PATIENT HAD BEEN RECEIVING THROUGH THE PICC. CONTRAST INJECTED THROUGH THE PICC DEMONSTRATED EXTRAVASATION INTO THE MEDIASTINUM. AT SUBSEQUENT VENOGRAM FOR REMOVAL (B)(6) 2017, THE TIP OF THE LOOPED PICC APPEARS EXTRAVASCULAR, PRESUMABLY ERODED INTO THE MEDIASTINUM DUE TO ITS LOOPED CONFIGURATION. THE PICC WAS REMOVED OVER A STIF

  Patient problems: Extravasation

  MAUDE report 6577209 ↗
• MalfunctionMay 17, 2017Difficult to Insert

  PER SALES REP, THE FACILITY REPORTED DIFFICULTY INSERTING THE INTRODUCER AND DILATOR. IT WAS STATED THAT THE DILATOR FRAYED AT THE END AND A NEW ONE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6572816 ↗
• MalfunctionMay 15, 2017Material Frayed; Failure to Advance

  PER SALES REP, THE FACILITY REPORTED DIFFICULTY INSERTING THE INTRODUCER AND DILATOR. IT WAS STATED THAT THE DILATOR FRAYED AT THE END AND A NEW ONE WAS USED TO COMPLETE THE PROCEDURE. THIS ADDRESSES LOT NUMBER REBN0332.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567989 ↗
• MalfunctionApr 27, 2017Leak/Splash

  IT WAS REPORTED ON (B)(6) 2017 THAT THE PICC WAS LEAKING. THE HEALTHCARE PROFESSIONAL WAS NOT ABLE TO VISUALISE THE LEAK WHEN FLUSHING BUT WAS VERY OBVIOUS ON INSPECTION OF THE PICC WHILE INSITU THAT THE ANTIBIOTIC WAS LEAKING AND NO LEAK WAS REPORTED FROM THE BUNG. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6525695 ↗
• MalfunctionAug 24, 2016Fluid/Blood Leak; Hole In Material; Chemical Spillage

  HEALTH PROFESSIONAL REPORTED THAT A PATIENT WAS RECEIVING CHEMOTHERAPY (CONTINUOUSLY) WITH HYDRATION. THE PATIENT HAD A POWER PICC INSERTED ON (B)(6) 2016. ON THE AFTERNOON OF (B)(6) 2016, THE PATIENT REPORTED FINDING A LARGE HOLE IN THE PICC LINE TUBING JUST DISTAL OF THE INSERTION SITE. REQUIRED PLACEMENT OF NEW DEVICE RESULTING IN DELAY OF MEDICATIONS. MILD SKIN IRRITATION/REDNESS AT SITE OF PICC INSERTION/LEAK WAS REPORTED.

  Patient problems: Chemical Exposure; Erythema; Skin Irritation

  MAUDE report 5901438 ↗