PowerPICC SOLO2 Catheter 3194355Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741027789), received between Jun 14, 2016 and Sep 2, 2026 — classified as 6 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 11, 2025Class IOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 2, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569743 ↗
• MalfunctionMay 5, 2026Difficult or Delayed Separation

  IT WAS REPORTED A POWERPICC WAS PLACED A FEW WEEKS AGO AND WHEN PEELING BACK THE PEEL AWAY, THE ORANGE TABS SNAPPED. CUSTOMER USED KELLY CLAMPS TO COMPLETE CATHETER PLACEMENT. NO HARM TO PATIENT TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085288 ↗
• MalfunctionDec 29, 2025Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT UPON REMOVAL OF (GUIDE WIRE) IT STARTED TO COME APART IN THE MIDDLE OF THE SURGERY. NO LONG-TERM EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919243 ↗
• MalfunctionJan 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT POWERPICC SOLO IS LEAKING, CUT/HOLE IN IT. PATIENT WHO WAS STARTING HIS ANTIBIOTICS IDENTIFIED THE PROBLEM BEFORE THE BEGINNING OF THE TREATMENT, PICC WAS REMOVED AND PIVC WAS INSERTED FOR THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138574 ↗
• InjuryDec 11, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT THE PATIENT ORIGINALLY HAD PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACED FOR USE WITH INTRAVENOUS (IV) ANTIBIOTIC INFUSION. PATIENT WAS DISCHARGED FROM THE HOSPITAL AT THAT TIME. THE PATIENT WAS THEN RE-ADMITTED ONE MONTH LATER AND THE PICC SITE WAS NOTED TO BE SWOLLEN. DOCTOR ORDERS WERE PLACED TO REMOVE THE PICC LINE AND SEND THE TIP FOR CULTURE. DURING THE REMOVAL, THE NURSE DOCUMENTED THAT THERE WAS NO RESISTANCE OR DIFFICULTY FELT WHEN REMOVING THE LINE. BUT WHAT WAS FOUND WAS THAT ONLY A PORTION OF THE PICC LINE CAME OUT. THE DOCTOR WAS IMMEDIATELY NOTIFIED, AND A CHEST AND ARM X-RAY WAS OBTAINED ALONG WITH AN ULTRASOUND OF THE ARM TO VERIFY THAT THE RETAINED PIECE IS STILL IN THE ARM. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY (IR) AND THE RETAINED PIECE WAS REMOVED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: Foreign Body In Patient; Swelling/ Edema

  MAUDE report 20905224 ↗
• InjuryNov 7, 2024Break; Break

  IT WAS REPORTED, PATIENT ADMITTED (B)(6) 24 FOR OSTEO OF HER RIGHT TOE. PATIENT WAS PREVIOUS ON 3RD FLOOR IN SEPTEMBER, DC'D WITH PICC LINE FOR HOME HEALTH ANTIBIOTIC TREATMENT. UPON ADMISSION THIS TIME, HER ARM WITH THE PICC LINE WAS SWOLLEN. LAST NIGHT THE MD ORDERED THE PICC TO BE REMOVED AND THE TIP SENT FOR CULTURES. WHEN THE PICC WAS REMOVED, THE PICC TUBING WAS SHORTEN THAN EXPECTED. THE RN NOTIFIED THE MD AND IT WAS VERIFIED VIA X-RAY AND US THAT PART OF THE LINE REMAINED IN THE PATIENT'S ARM. SHE ALSO HAS A DVT. PART OF THE PICC THAT WAS REMOVED WAS SENT TO LAB FOR CULTURE TESTING PER MD ORDERS. THE PATIENT HAS ORDERS TO GO TO IR THIS MORNING TO REMOVE THE RETAINED PORTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 20633985 ↗
• MalfunctionOct 20, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE RADIOLOGIST WAS UNDERGOING A PICC INSTALLATION WITH A DIFFICULT -FRAGILE VEIN PATIENT. AS THE DR WAS ADVANCING THE GUIDE WIRE THROUGH THE SHIELD INTO THE PATIENT , DR. FELT RESISTANCE. WHEN HE PULLED BACK THE EXTREMITY OF THE GUIDE WIRE WAS COILED IT WAS STILL HOLDING ON TO THE MAIN GUIDEWIRE BUT THE DR. WAS SACRED THE END COULD HAVE BROKEN OFF AND MIGRATED TO THE HEART. THE DR. THEN TOOK A NEW VEIN AND A NEW PICC TRAY AND RESTARTED THE PICC INSERTION PROCESS. AGAIN HE COULD NOT REMOVE THE GUIDEWIRE FROM THE SHEALTH. HE HAD TO NOT ONLY PULL STRONGER BUT HE HAD TO REMOVE THE SHEALTH TO RETRIEVE THE GUIDE WIRE. ONCE RETRIEVED THE WIRE WAS AGAIN COILED AT THE EXTREMITY ADDITIONAL INFO FROM CUSTOMER: (13-OCT-2023) THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. THE ISSUE WAS HOW WAS DISCOVERED DURING THE INSERTION OF THE CATHETER. THE WIRE DID NOT BREAK INTO TWO OR MORE PIECES AND NO PIECES WERE RETAINED IN THE PATIENT. THE CATHETER WAS NOT ABLE TO ADVANCE DUE TO THE DEFECT IN THE GUIDE WIRE. NO IMAGING WAS TAKEN AND THERE WAS NO NEGATIVE OUTCOME TO THE PATIENT. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981565 ↗
• MalfunctionOct 17, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE RADIOLOGIST WAS UNDERGOING A PICC INSTALLATION WITH A DIFFICULT -FRAGILE VEIN PATIENT. AS THE DR WAS ADVANCING THE GUIDE WIRE THROUGH THE SHIELD INTO THE PATIENT , DR. FELT RESISTANCE. WHEN HE PULLED BACK THE EXTREMITY OF THE GUIDE WIRE WAS COILED IT WAS STILL HOLDING ON TO THE MAIN GUIDEWIRE BUT THE DR. WAS SACRED THE END COULD HAVE BROKEN OFF AND MIGRATED TO THE HEART. THE DR. THEN TOOK A NEW VEIN AND A NEW PICC TRAY AND RESTARTED THE PICC INSERTION PROCESS. AGAIN HE COULD NOT REMOVE THE GUIDEWIRE FROM THE SHEALTH. HE HAD TO NOT ONLY PULL STRONGER BUT HE HAD TO REMOVE THE SHEALTH TO RETRIEVE THE GUIDE WIRE. ONCE RETRIEVED THE WIRE WAS AGAIN COILED AT THE EXTREMITY ADDITIONAL INFO FROM CUSTOMER: (13-OCT-2023) THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. THE ISSUE WAS HOW WAS DISCOVERED DURING THE INSERTION OF THE CATHETER. THE WIRE DID NOT BREAK INTO TWO OR MORE PIECES AND NO PIECES WERE RETAINED IN THE PATIENT. THE CATHETER WAS NOT ABLE TO ADVANCE DUE TO THE DEFECT IN THE GUIDE WIRE. NO IMAGING WAS TAKEN AND THERE WAS NO NEGATIVE OUTCOME TO THE PATIENT. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949719 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER "PATIENTS CODING OR SHORTNESS OF BREATHE AFTER PLACING PICC LINE IN IR SUITE". NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Cardiac Arrest; Dyspnea

  MAUDE report 16714490 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER "PATIENTS CODING OR SHORTNESS OF BREATHE AFTER PLACING PICC LINE IN IR SUITE". NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Cardiac Arrest; Dyspnea

  MAUDE report 16714369 ↗
• MalfunctionMar 14, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT "WE HAD AN ISSUE LAST NIGHT WITH A PICC LINE. THE DOCTOR WAS ATTEMPTING TO REMOVE THE WIRE AFTER THE PICC CATHETER WAS INSERTED AND THE WIRE BECAME STUCK. ONCE HE WAS FINALLY ABLE TO REMOVE IT THE WIRE CAME OUT FRAYED. THERE WAS NO PATIENT HARM. THE WIRE DID NOT BREAK. THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING SITUATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16540268 ↗
• MalfunctionSep 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PICC LINE IS COMING OUT 5CM. NURSE STATED CAN'T FLUSH OR ADMINISTER MEDICATION. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418019 ↗
• MalfunctionApr 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED VIA MS&S "PATIENT STATES HE HAD A POWERPICC SOLO PLACED (B)(6) 2022. PATIENT STATES THE CATHETER IS KINKING WHERE THE VALVE MEETS THE LUMEN LEG, PATIENT STATES IT STILL FLUSHES HOWEVER WHILE INFUSING HIS MEDICATION, IT IS NOW TAKING LONGER DUE TO THE KINK. PATIENT STATES HE CANNOT HAVE ANOTHER POWERPICC PLACED." MS&S RESPONSE "VERIFIED WITH PATIENT HIS POWERPICC FLUSHES, PATIENT CONFIRMED HE HAS DRESSING ON THE POWERPICC TO STABILIZE THE DEVICE. INFORMED PATIENT HIS INFORMATION WOULD BE SENT TO COMPLAINTS DEPARTMENT FOR INVESTIGATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135873 ↗
• MalfunctionApr 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED VIA PHONE CALL, "PATIENT HAVE A POWERPICC CATHETER IN HIS ARM TO DELIVER ANTIBIOTIC IN HIS SYSTEM BUT THE TUBING IS COLLAPSING." CUSTOMER RESPONDED VIA PHONE CALL (B)(6) 2022 "THERE IS MATERIAL FATIGUE AT THE CONNECTION BECAUSE OF STRESS. THERE IS NO MATERIAL SUPPORT AT THE END OF THE TUBE AND THE CONNECTOR, THE CUSTOMER HAS NO FURTHER INFORMATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14114119 ↗
• MalfunctionDec 15, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL, "WE HAVE AN ISSUE WITH THE CATHETER 4FRENCH GUIDEWIRE. THERE ARE SUPPOSED TO BE LITTLE BLACK LINES THAT ¿MEASURE¿ THE LENGTH OF THE WIRE. THEY ARE MISSING¿THUS, WE CANNOT USE THESE AT ALL." ADDITIONAL INFO. RECEIVED 12/06/2021 "THE MEASUREMENT MARKINGS ARE ABSENT ON A SECTION OF THE PICC CATHETER. THERE ARE NO ISSUES WITH THE GUIDE WIRE. WE REQUIRE THE MEASUREMENT MARKINGS A VITAL COMPONENT OF THE PICC LINE." IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012327 ↗
• MalfunctionDec 15, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL, "WE HAVE AN ISSUE WITH THE CATHETER 4FRENCH GUIDEWIRE. THERE ARE SUPPOSED TO BE LITTLE BLACK LINES THAT ¿MEASURE¿ THE LENGTH OF THE WIRE. THEY ARE MISSING¿THUS, WE CANNOT USE THESE AT ALL." ADDITIONAL INFO. RECEIVED 12/06/2021 "THE MEASUREMENT MARKINGS ARE ABSENT ON A SECTION OF THE PICC CATHETER. THERE ARE NO ISSUES WITH THE GUIDE WIRE. WE REQUIRE THE MEASUREMENT MARKINGS A VITAL COMPONENT OF THE PICC LINE. " IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012304 ↗
• MalfunctionDec 15, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL, "WE HAVE AN ISSUE WITH THE CATHETER 4FRENCH GUIDEWIRE. THERE ARE SUPPOSED TO BE LITTLE BLACK LINES THAT ¿MEASURE¿ THE LENGTH OF THE WIRE. THEY ARE MISSING¿THUS, WE CANNOT USE THESE AT ALL." ADDITIONAL INFO. RECEIVED 12/06/2021 "THE MEASUREMENT MARKINGS ARE ABSENT ON A SECTION OF THE PICC CATHETER. THERE ARE NO ISSUES WITH THE GUIDE WIRE. WE REQUIRE THE MEASUREMENT MARKINGS A VITAL COMPONENT OF THE PICC LINE." IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012299 ↗
• MalfunctionDec 15, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL, "WE HAVE AN ISSUE WITH THE CATHETER 4FRENCH GUIDEWIRE. THERE ARE SUPPOSED TO BE LITTLE BLACK LINES THAT ¿MEASURE¿ THE LENGTH OF THE WIRE. THEY ARE MISSING THUS, WE CANNOT USE THESE AT ALL." ADDITIONAL INFO. RECEIVED 12/06/2021 "THE MEASUREMENT MARKINGS ARE ABSENT ON A SECTION OF THE PICC CATHETER. THERE ARE NO ISSUES WITH THE GUIDE WIRE. WE REQUIRE THE MEASUREMENT MARKINGS A VITAL COMPONENT OF THE PICC LINE." IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012296 ↗
• InjuryOct 13, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED "UPON INJECTING SALINE INTO THE POWERPICC SOLO # 3194355 THE PATIENT HAD A SEVERE ALLERGIC REACTION UPON INJECTION OF SALINE INTO THE CATHETER, REQUIRING MEDICAL INTERVENTION. WE TREATED THE ALLERGIC REACTION WITH MEDICATION." IT WAS ALSO REPORTED VIA MS&S "I HAVE A DOCTOR WHO JUST CALLED WITH A PATIENT HAVING A SEVERE REACTION AFTER FLUSHING POWERPICC HE JUST PLACED. HE PREPPED THE PATIENT WITH CHLORHEXIDINE, ALLOWED IT TO DRY WHILE SETTING UP HIS STERILE TRAY. AFTER PLACING THE PICC HE USED A SYRINGE TO PULL BACK TO CONFIRM PLACEMENT WITH BLOOD RETURN. HE THEN PROCEEDED TO INJECT SALINE TO FLUSH THE LINE AND THE PATIENT STARTED HAVING THE REACTION WITH SEVERE SHORTNESS OF BREATH. COULD HE HAVE INJECTED CHLORHEXIDINE FROM THE SKIN PREP?" MS&S: RESPONSE EXPLAINED TO THE CALLER THAT I HAVE SEEN THE INCORRECT MEDICINE GET INJECTED INTO THE LINE AND CAUSE REACTIONS. THE REACTION OCCURRED AFTER THE INJECTION OF THE SUSPECTED "SALINE". PROVIDED THE CALLER WITH MATERIAL OF CONSTRUCTION FOR THE POWERPICC. POWERPICC SOLO IS MADE OF POLYURETHANE CATHETER, SILICONE VALVE IN HUBS AND DOES NOT CONTAIN ANY NATURAL RUBBER LATEX. INFORMED THE REP THAT THE INCIDENT NEEDED TO BE REP

  Patient problems: Dyspnea

  MAUDE report 12627142 ↗
• MalfunctionFeb 8, 2018Leak/Splash; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON 5 CM BELOW THE WING OF THE PICC THERE WAS A LEAK. THE HEALTH CARE PROFESSIONAL THOUGHT IT WAS INSERTION ERROR AS THE PICC WAS BRAND NEW AND ONCE IT MIGRATED OUT A FEW CMS, IT BEGAN TO LEAK. THE PICC WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7251070 ↗
• MalfunctionDec 22, 2017Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED ON 11/28/2017, THAT THE CATHETER WAS CUT AT 44CM WITH DISTANCE FROM SKIN AND TWO ATTEMPTS WERE MADE FOR ACCESS. IT WAS STATED THE HEALTHCARE PROFESSIONAL ACCESSED THE PICC DURING THE ROUTINE DRESSING PROCEDURE AND A HOLE WAS NOTED AS FLUID LEAKED FROM THE PICC. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7142555 ↗
• InjuryJun 23, 2017Fracture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2017 THE TIP OF A GUIDEWIRE FRACTURED WITH APPROXIMATELY 2 CM LEFT INSITU (IN THE PATIENT). IT WAS CONFIRMED BY THE HEALTHCARE PROFESSIONAL (HCP) THAT THIS BELONGED TO THE BARD KIT. THE HCP NOTED USER ERROR MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 6663677 ↗
• MalfunctionJul 1, 2016Burst Container or Vessel

  IT WAS REPORTED BY SALES REP, PATIENT HAD CATHETER PLACED. ONCE THE CATHETER WAS PLACED THE PATIENT FELT A POP. CATHETER WAS REMOVED, A NEW DEVICE WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5765064 ↗
• MalfunctionJul 1, 2016Device Operates Differently Than Expected

  IT WAS REPORTED BY SALES REP, PATIENT HAD CATHETER PLACED. ONCE THE CATHETER WAS PLACED THE PATIENT FELT A POP. CATHETER WAS REMOVED, A NEW DEVICE WAS PLACED.

  Patient problems: No Code Available

  MAUDE report 5765052 ↗
• MalfunctionJun 14, 2016Peeled/Delaminated

  IT WAS REPORTED THAT WHILE PEELING AWAY THE SHEATH, THE SHEATH FAILED TO BREAK AWAY COMPLETELY, LEAVING A PLASTIC RING SURROUNDING THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5723529 ↗