PowerPICC SOLO2 Catheter 1194108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 216 adverse event reports that list this exact device (DI 00801741034510), received between Feb 3, 2016 and Sep 2, 2026 — classified as 36 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (57 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 21, 2026Class IIOpen, 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 · Recall details · FDA record ↗

2. 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 216 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Unsealed Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569745 ↗
• InjuryMar 12, 2026Material Frayed

  IT WAS REPORTED VIA MEDWATCH, PICC LINE NURSE WAS PLACING A PICC LINE IN THE PATIENT'S RIGHT UPPER ARM WHEN IT APPEARS IT BECAME "STUCK". AFTER REMOVAL, THE GUIDEWIRE WAS NOTED TO BE FRACTURED, AND PORTION OF THE GUIDEWIRE REMAINED IN THE PATIENT (APPROXIMATELY 3 CM). IMMEDIATE PRESSURE WAS HELD, AND INTERVENTIONAL RADIOLOGY (IR) EVALUATED THE SITUATION BUT DID NOT BELIEVE THEY WERE ABLE TO REMOVE THE RETAINED WIRE. VASCULAR WAS CONSULTED AND DID NOT RECOMMEND REMOVING IT. A NEW PICC LINE WAS PLACED FOR TREATMENT WHILE IN IR.

  Patient problems: Foreign Body In Patient

  MAUDE report 24587404 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  IT WAS REPORTED WE HAD A FRACTURED PICC INCIDENT WITH A PATIENT. A HOLE WAS FOUND NEXT TO THE 0CM MARK. PATIENT'S LINE WAS LEAKING. LINE HAD TO BE REPLACED SO PATIENT HAD TO UNDERGO ANOTHER PICC INSERTION PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498657 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED SOMETIME AFTER THE PICC PLACEMENT, THE PATIENT WAS DIAGNOSED WITH AN UNSPECIFIED INFECTION, SEPSIS AND PULMONARY EMBOLISM. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pulmonary Embolism; Sepsis

  MAUDE report 24405654 ↗
• MalfunctionFeb 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT PICC LINE LEAKING UNDER DRESSING. ASSESSED LINE WITH USG MACHINE, NO CLOTS NOTED, VESSEL APPEARS HEALTHY. PICC LINE PULLED. AFTER REMOVING PICC LINE, ATTACHED FLUSH, AND COULD SEE SMALL SLIT IN PICC LINE WHERE FLUID WAS LEAKING. LENGTH CONFIRMED AND TIP INTACT. PATIENT HAD TO HAVE THEIR PICC REMOVED AND A NEW ONE PLACED. PICC LEAKING WHEN FLUSHED A FEW INCHES DOWN THE LINE FROM THE CLAVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387917 ↗
• InjuryJan 26, 2026Material Frayed; Improper or Incorrect Procedure or Method

  IT WAS REPORTED, PICC LINE PLACEMENT BY OUR PICC LINE NURSE. PLACED WITHOUT DIFFICULTY. WHEN SHE ATTEMPTED TO WITHDRAW THE GUIDEWIRE WITH GENTLE PULLING, IT WAS NOTED TO BE ¿STUCK¿. CATHETER WITHDRAWN WHILE SIMULTANEOUSLY ATTEMPTING TO GENTLY WITHDRAW GUIDEWIRE. ONCE PICC LINE OUT, GUIDEWIRE WAS NOTED TO HAVE FRAYING AT THE TIP. TOURNIQUET WAS TIGHTENED AND PRESSURE HELD AT INSERTION SITE WHILE NOTIFYING IR TEAM. FLUOROSCOPY EVALUATION DEMONSTRATED APPROXIMATELY 3 CM LONG GUIDEWIRE 0.018 SIZE IN MID ARM. BASED ON RADIOGRAPHIC ASSESSMENT, THE FRACTURED WIRE APPEARED TO BE DEEPER THAN SUBCUTANEOUS TISSUES AND MAY HAVE RETRACTED FROM THE INSERTION SITE NEAR THE BRACHIAL OR BASILIC VEIN. THERE IS VERY LOW LIKELIHOOD THIS SMALL, RETAINED WIRE FRAGMENT, WILL BE ASSOCIATED WITH SYMPTOMS OR SIGNIFICANT FUTURE COMPLICATIONS. CHEST XRAY WAS COMPLETED TO ASSESS FOR WIRE FRAGMENTS AND POSSIBLE EMBOLIZATION IN THE CHEST. X-RAY NEGATIVE. VASCULAR SURGERY CONSULTED. THEY HAVE NOT SEEN THE PATIENT YET. ADDITIONAL INFORMATION PROVIDED JANUARY 21: AFTER THE CONSULT, IT WAS DECIDED TO LEAVE IT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24176906 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THEY PULLED THE PICC LINE, THEY DISCOVERED A HOLE IN THE LINE AROUND THE 5 OR 6CM MARK. THE CATHETER WAS SECURE WITH THE STATLOCK. THE LEAK WAS INTERNAL 5-6 CM INSIDE. NO ADDITIONAL INTERVENTION NEEDED TO REMOVE PICC, A VASCULAR STUDY WAS DONE TO ENSURE NO CLOT FORMATION. A NEW PICC WAS INSERTED ON THE FOLLOWING MONDAY. NO DELAY IN TREATMENT, THAT WAS THE NEXT CHEMO DOSE DAY.

  Patient problems: Pain

  MAUDE report 23586684 ↗
• MalfunctionNov 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT LEAKING AT THE JUNCTION OF THE CATHETER AND THE CATHETER HUB (WINGED AREA FOR STATLOCK) AT THE TOP OF THE REVERSE TAPER. (B)(6) 2025 - PICC INSERTION PER VASCULAR ACCESS TEAM- STANDARD PROCEDURE REPORTED. (B)(6) 2025- VASCULAR ACCESS TEAM NOTED LEAKING AT THE JUNCTION OF THE CATHETER AND THE CATHETER HUB (WINGED AREA FOR STATLOCK) AT THE TOP OF THE REVERSE TAPER. CATHETER REMOVED AND REPLACED WITH NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486942 ↗
• MalfunctionOct 30, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT WHEN PLACING THE PICC THE WIRE WENT IN SMOOTHLY, INTRODUCER PLACED W/O INCIDENT. WHEN RETRACTING THE WIRE FROM THE INTRODUCER IT MADE IT MOST OF THE WAY OUT BUT WAS NOT ABLE TO BE REMOVED FULLY. I INSTRUCTED HER TO REMOVE BOTH WIRE AND INTRODUCER AT THE SAME TIME AS WE WOULD IF IT WERE THE NEEDLE INSTEAD OF THE INTRODUCER. THE INTRODUCER WAS REMOVED FULLY BUT THE WIRE AT JUST THE MOST DISTAL TIP WAS UNDER THE SKIN AND WOULD NOT BUDGE. I WAS GOWNED UP AT THIS POINT AND COULD SEE THE WIRE IN HIS TISSUE. WHEN I REMOVED THE PROBE FROM HIS ARM IT MUST HAVE MANIPULATED THE WIRE JUST ENOUGH THAT IT CAME OUT ON ITS OWN. NEITHER ONE OF US PULLED OR TUGGED TRYING TO EXTRACT IT. WHEN I EXAMINED IT THE VERY END OF THE ORIGINAL WIRE WHERE THE FLOPPY CASING IS THAT CASING WAS PULLED BACK FROM THE INNER WIRE. IT WILL RE-SHEATH ITSELF, BUT IT DEFINITELY PULLS BACK AND EXPOSES A ROUGHER EDGE. IT'S LIKE, A MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424494 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT PICC LEAKING AT INSERTION SITE, UPON REMOVAL PICC FELL APART. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359762 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC FRACTURE OBSERVED SEVERAL CM'S FROM HUB. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353823 ↗
• MalfunctionOct 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION: ASSOCIATED PATIENT(S) HAD XRAYS DONE THE NEXT MORNING IN THE ICU. THERE HAVE BEEN NO KNOWN INJURIES. ONE PICC WAS REPOSITIONED LAST YEAR DUE TO THE PICC TIP ENDING IN THE PROXIMAL SVC. PATIENT WAS TO RECEIVE A VESICANT WITH OSMOLARITY GREATER THAN 900.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23267422 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025: 1222 #CATHETER SIZE 4 FR SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER INSERTED TO THE RIGHT BASILIC VEIN PER HOSPITAL PROTOCOL. PATIENT DISCHARGED HOME WITH PICC LINE. AT 1600 PT RETURNED TO HOSPITAL WITH COMPLAINTS OF THROBBING PAIN AND NUMBNESS IN FINGERS IN RIGHT ARM, WHERE PICC LINE WAS PREVIOUSLY PLACED EARLIER TODAY, RADIAL PULSE STRONG, FINGERTIPS SLIGHTLY COOL TO TOUCH, CAPILLARY REFILL BRISK, PICC LINE REMOVED TIP INTACT 39 CM. PT ALSO C/O SHORTNESS OF BREATH AND CHEST PAIN AND DIZZINESS PRIOR TO REMOVAL OF PICC LINE. PT WAS TAKEN TO ED FOR FURTHER EVALUATION. WHEN SEEN AT THE ER SYMPTOMS WERE RESOLVED. ADDITIONAL INFORMATION RECEIVED: MD INITIAL ASSESSMENT STATED PATIENT STATED HAD CHEST PAIN EARLIER IN THE DAY BUT NONE ARE PRESENT NOW, AND STATED SHORTNESS OF BREATH IS NOT PRESENT AT THIS TIME. SYMPTOMS DID NOT RESOLVE WITH PICC REMOVAL SO PATIENT PROCEEDED TO THE ER. WHEN SEEN AT THE ER, THE SYMPTOMS HAD RESOLVED. NO ADDITIONAL INTERVENTION WAS PROVIDED SINCE THE SYMPTOMS RESOLVED.

  Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Numbness

  MAUDE report 23066135 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PAIN FROM ELBOW TO THE SHOULDER AND CHEST PAIN. DELAY IN THERAPY. DISCOMFORT FOR THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 22956095 ↗
• MalfunctionAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDWATCH SINGLE LUMEN BARD POWERPICC SOLO 4 FRENCH RUPTURED WHILE CT CONTRAST GOING THROUGH IT. ADDITIONAL INFORMATION: THE LEAK IS INTERNAL TO THE PATIENT. THERE WAS NO RESISTANCE TO FLUSHING PRIOR TO THE CT. INJECTION RATE WAS 325 AT MAX PEAK, AT 4ML/SEC. THE EVENT DID NOT CAUSE A SUBOPTIMAL CT IMAGE. PICC LINE WAS SECURED WITH STATLOCK AND TAGADERM. PATIENT DID NOT SHOW ANY SYMPTOMS RELATED TO THE LEAK, BUT TREATMENT WAS DELAYED AND THE PATIENT WAS TREATED WITH A WARM COMPRESS. CATHETER WAS REMOVED, A NEW ONE WAS NOT PLACED. THERE WAS EXTRAVASATION OF CONTRAST IN LEFT UPPER ARM BUT PATIENT HAS RECOVERED.

  Patient problems: Extravasation

  MAUDE report 22906638 ↗
• InjuryJul 10, 2025Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT THE DURING THIS PROCEDURE, THE NURSE MET RESISTANCE WITH ADVANCING THE GUIDEWIRE THROUGH THE NEEDLE. SO, SHE HAD TO SLOWLY ¿INCH BY INCH¿ REMOVE BOTH NEEDLE AND WIRE TOGETHER. ONCE COMPLETELY OUT THE WIRE WAS NOT BENT BUT IT WAS SHEARED. THE NURSE USED A DIFFERENT GUIDEWIRE AND WAS ABLE TO PLACE PICC. HUMERUS XRAY WAS COMPLETED ON LEFT UPPER EXTREMITY WHICH REVEALED APPROXIMATELY 2.2 CM THIN CURVILINEAR METALLIC DENSITY WITHIN THE SOFT TISSUES ADJACENT TO THE PROXIMAL ASPECT OF THE PICC. PATIENT WAS TRANSPORTED TO HOSPITAL FOR EVALUATION AND TREATMENT UNDER VASCULAR SURGEON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22473375 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER PICC RUPTURED DURING CT. ADDITIONAL INFORMATION RECEIVED: PICC WAS INSERTED ON (B)(6). ON (B)(6), PATIENT WENT TO CT FOR A SCAN AND THE PICC WAS WRAPPED IN COBAN. THE CT SCAN WAS SUCCESSFUL, BUT AFTERWARD THE CT TECH AND PATIENT NOTICED IT WAS LEAKING. THE PICC APPEARED TO HAVE A RUPTURE WITH SALINE LEAKING UNDER THE DRESSING, AND THE PATIENT REPORTED TO THE CT TECH THAT THE PICC ¿EXPLODED¿. NO INJURY WAS REPORTED, AND THE PICC WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018278 ↗
• MalfunctionApr 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED PICC TIPS BENDING UNUSUALLY ON INSERTION, HAS HAPPENED TO MORE THAN ONE PICC. NO OTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF DEVICES INVOLVED WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903355 ↗
• MalfunctionApr 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE IV THERAPY PLACED AN RL OF A PICC LINE THAT WAS REMOVED THAT HAD A HOLE PERFORATED IN THE SIDE. PATIENT HAD CRAMPING/PAIN AT THE SITE AFTER INFUSION, NO OTHER COMPLICATIONS OTHER THAN HAVING TO REMOVE THE LINE.

  Patient problems: Pain

  MAUDE report 21752641 ↗
• MalfunctionMar 5, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED BY CUSTOMER THAT "DURING A PICC PLACEMENT TODAY, I HAD AN INTRODUCER NOT TEAR APPROPRIATELY. PART OF THE ORANGE HANDLE DID NOT SEPARATE, WHICH I THINK CAUSED THE GREY PART TO NOT TEAR AS WELL. I KNOW WE HAD THIS HAPPEN ONE OTHER TIME WITHIN THE LAST FEW MONTHS. NO PATIENT HARM/INJURY OCCURRED." THIS REPORT ADDRESSES THE EVENT ON JANUARY 16, 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525801 ↗
• MalfunctionFeb 25, 2025Activation Problem; Activation Problem

  IT WAS REPORTED OPENED A PICC KIT TO SEE HOW THE SAFETY OF SECURLOC NEEDLE WORKED. THIS WAS NOT USED ON A PATIENT. HE SAID THE GREEN SAFETY SLID OFF. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21465638 ↗
• MalfunctionFeb 19, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE GREEN SECUR LOC SAFETY FELL OFF AFTER PLACEMENT. NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411149 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A PATIENT WITH A PICC THAT FRACTURED AT THE 4CM MARK. WE PLACED THE PICC (B)(6) 2024 AND THE PATIENT WAS DISCHARGED ON HOME IVAB TX. HE RETURNED TO THE ED (B)(6) 2025 WITH COMPLAINT OF DIFFICULTY INFUSING AND PAIN AT SITE. WE REMOVED THE PICC AND FOUND A HOLE AT THE 4CM MARK. NEW LINE PLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 21381750 ↗
• MalfunctionFeb 13, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THE CUSTOMER WAS INSERTING A PICC LINE AND THE GREEN SAFETY HAS FALLEN OFF OF THE SECURE-LOC NEEDLE IN THE PICC KIT. NO PATIENT OR CLINICIAN HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381578 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A PICC FOUND TO BE FRACTURED AT THE 5CM MARK AFTER IT WAS IN THE PATIENT FOR 3 WEEKS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381572 ↗