PowerPICC SOLO2 CatheterRecalls & reported problems across all models

We found 20 models of PowerPICC SOLO2 Catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 517 adverse event reports in the FDA's MAUDE database, received between Dec 4, 2015 and Sep 2, 2026 — classified as 2 deaths, 84 injuries, 431 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (95 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PowerPICC SOLO2 Catheter recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 21, 2026Open, 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 · names 4 of these models · Recall details · FDA record ↗

2. 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 · names 8 of these models · Recall details · FDA record ↗

Most reported PowerPICC SOLO2 Catheter problems

PowerPICC SOLO2 Catheter models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PowerPICC SOLO2 Catheter 1194108D

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  2 recalls216 reports
• PowerPICC SOLO2 Catheter 1295108D

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall125 reports
• PowerPICC SOLO2 Catheter 3194108D

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  2 recalls10 reports
• PowerPICC SOLO2 Catheter 3194355

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall25 reports
• PowerPICC SOLO2 Catheter 3194335

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall18 reports
• PowerPICC SOLO2 Catheter 3194118

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall10 reports
• PowerPICC SOLO2 Catheter 3194155

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall10 reports
• PowerPICC SOLO2 Catheter 3194135

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall3 reports
• PowerPICC SOLO2 Catheter 3194108

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall2 reports
• PowerPICC SOLO2 Catheter 3295108D

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall2 reports
• PowerPICC SOLO2 Catheter 3295335

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  25 reports
• PowerPICC SOLO2 Catheter 3295355

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  19 reports
• PowerPICC SOLO2 Catheter 1396108D

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  10 reports
• PowerPICC SOLO2 Catheter 3295135

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  9 reports
• PowerPICC SOLO2 Catheter 3396108

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  9 reports
• PowerPICC SOLO2 Catheter 3295118

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  7 reports
• PowerPICC SOLO2 Catheter 3295155

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  2 deaths7 reports
• PowerPICC SOLO2 Catheter 3396355

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  6 reports
• PowerPICC SOLO2 Catheter 3396135

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  2 reports
• PowerPICC SOLO2 Catheter 3396335

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  2 reports

Recent PowerPICC SOLO2 Catheter adverse event reports

The 15 most recent reports across all models, 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 2, 2026Unsealed Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569745 ↗
• MalfunctionSep 2, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569743 ↗
• MalfunctionSep 2, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569341 ↗
• MalfunctionSep 2, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569339 ↗
• MalfunctionSep 1, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543393 ↗
• MalfunctionMay 27, 2026Unsealed Device Packaging

  IT WAS REPORTED PICC NURSE NOTICED THAT THE PICC KIT WAS RECEIVED WITH A DEFECTIVE SEAL. THE KIT WAS UNUSABLE AND HAD TO BE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303186 ↗
• MalfunctionMay 19, 2026Product Quality Problem

  IT WAS REPORTED PLACED A DOUBLE LUMEN PICC ON A PATIENT FOR DISCHARGE. WHEN I WENT TO FLUSH THE RED LUMEN DURING INSERTION, THE STOPPER HOLDING THE WIRE POPPED OFF. THIS CAUSED A FAULTY READING ON THE ECG SINCE I COULDN'T PUT THE STOPPED BACK IN AND I HAD TO GET A CHEST XRAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218583 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 3, 2026Product Quality Problem

  IT WAS REPORTED BY THE CUSTOMER THAT DURING PICC LINE INSERTION, THE PULL TAB USED TO CONNECT THE 3CG SYSTEM TO THE SHERLOCK¿ CHEST PLATE WAS STRIPPED OF ITS PLASTIC PROTECTIVE COATING, RESULTING IN EXPOSED WIRE. THE FAULTY WIRE WAS NOT CONNECTED TO THE SHERLOCK CHEST PLATE. THE DEVICE ISSUE RESULTED IN A DELAY OF TREATMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251494 ↗

Other Bard Access Systems, Inc. products

• Port Access Needle122 models · 3,744 reports · 3 recalls
• Groshong NXT ClearVue Catheter8 models · 3,266 reports
• PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
• Site~Rite 8 Ultrasound System11 models · 1,965 reports
• PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
• PowerPICC Provena116 models · 1,337 reports · 2 recalls
• PowerPort M.R.I., Groshong10 models · 1,285 reports
• Navarre15 models · 1,228 reports