PowerPICC SOLO2 FT CatheterRecalls & reported problems across all models

We found 5 models of PowerPICC SOLO2 FT Catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 72 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2016 and Apr 1, 2026 — classified as 12 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 reports).

1 FDA recall record name at least one of these models by its device 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. 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 FT 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 · Recall details · FDA record ↗

Most reported PowerPICC SOLO2 FT Catheter problems

PowerPICC SOLO2 FT Catheter models

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

• PowerPICC SOLO2 FT Catheter 1295108FD

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall57 reports
• PowerPICC SOLO2 FT Catheter 3295108FD

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

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  5 reports
• PowerPICC SOLO2 FT Catheter 3295108F

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  3 reports
• PowerPICC SOLO2 FT Catheter 3295335F

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 report

Recent PowerPICC SOLO2 FT Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT PATIENT WAS ENGAGING IN SELF-ACTIVITY WHEN THE PURPLE LUMEN "FELL OFF" THE DUAL LUMEN PICC. THIS CAUSED FOR REMOVAL AND BLOOD LEAKING OUT OF PATIENTS ARM WHERE THE LUMEN HAD "FELL OFF". REMOVED IV ACCESS, PATIENT TRAUMA, HAD TO REPLACE AND GO THROUGH A PICC PROCEDURE AGAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758360 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING PICC LEG. OVERLINE EXCHANGE AFTER AFFECTED LEAKING PICC NOTICED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475683 ↗
• MalfunctionAug 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PICC WAS LEAKING AT THE 0 CM OR 1 CM MARK. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881421 ↗
• MalfunctionJul 28, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT THE PICC IS DISCOLORED IN THE AREA WHERE SECUREMENT DEVICE WOULD BE PLACED. NO PATIENT HARM WAS CAUSED AS A RESULT. ON (B)(6) 2025: THE RETURNED DEVICE EXHIBITED DISCOLORATION A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631623 ↗
• MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC BROKE AND LEAKED AT THE INSERTION SITE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401554 ↗
• InjuryMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETER REMOVED DUE TO FISSURE DURING USE. IT WAS LAID ON (B)(6) 2024, REMOVED ON (B)(6) 2025. IT WAS NOT TUNNELED. IT DID NOT HAVE A SUBCUTANEOUS ANCHORING SET (SECURACATH). IT WAS ATTACHED WITH STATLOCK. THE INSERTION POINT IS AT THE ZERO OF THE CATHETERS (THERE WAS NO CATHETER OUTSIDE). ADDITIONAL INFORMATION: PATIENT HAD EXTRAVASATION OF CYTOTOXIC AGENT, THERE WAS EXTENSIVE CELLULITIS IN THE AFFECTED LIMB.

  Patient problems: Cellulitis; Extravasation

  MAUDE report 22018276 ↗
• MalfunctionDec 12, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER, CATHETER NOT POWER FLUSHING WHEN IT FLIPS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919615 ↗
• MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY CUSTOMER THAT STIFFENING STYLET IS BENDING BACK ON ITSELF DURING INSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192981 ↗
• MalfunctionFeb 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S POWER PICC CAME COMPLETELY OUT OF HER ARM. SHE DOES NOT KNOW HOW HER POWER PICC CAME OUT OF HER ARM BUT STATES THE HOME HEALTH NURSE CHANGED THE DRESSING YESTERDAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767050 ↗
• MalfunctionNov 20, 2023Material Deformation; Material Deformation

  CUSTOMER STATED THAT GUIDEWIRE COILS WHEN BEING INSERTED INTO PATIENT. SHE STATED THIS HAS HAPPENED SEVERAL TIMES, BUT DOES NOT KNOW HOW MANY TIMES OR SPECIFIC DATES. ADDITIONAL INFORMATION PROVIDED 10/30/2023: AFTER GUIDEWIRE COILS, IT MAY OR MAY NOT BE ABLE TO BE USED; MULTIPLE OCCASIONS OF OPENING A SECOND KIT TO REPLACE THE GUIDEWIRE WHICH CAUSES A DELAY OF ACCESS. EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. EXTENDED TIME FOR INSERTION DUE TO DIFFICULTY AND HAVING TO OPEN ANOTHER KIT. MULTIPLE KITS HAD TO BE USED. NO PATIENTS HARMED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175572 ↗
• MalfunctionNov 20, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT GUIDEWIRE COILS WHEN BEING INSERTED INTO PATIENT. ADDITIONAL INFORMATION PROVIDED 10/30/2023: AFTER GUIDEWIRE COILS, IT MAY OR MAY NOT BE ABLE TO BE USED; OPENING A SECOND KIT TO REPLACE THE GUIDEWIRE WHICH CAUSES A DELAY OF ACCESS. THIS DID NOT CAUSE AN URGENT SITUATION, BUT EXTENDED TIME FOR INSERTION DUE TO DIFFICULTY AND HAVING TO OPEN ANOTHER KIT. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173890 ↗
• MalfunctionSep 22, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD AN INSERTION WHERE IT WAS ALLOWING AIR INTO THEIR SYRINGE WHEN THEY ASPIRATED BLOOD DURING INSERTION. THEY TIGHTENED THE CONNECTIONS, AND IT APPEARED TO BE POSSIBLY COMING IN THROUGH THE HUB WHERE THE WIRE IS (THE WIRE THAT WILL BE REMOVED AT THE END OF THE PICC INSERTION). (B)(6) 2023 - AFTER ENGINEER REVIEW CLARIFIED UNDERSTANDING OF THE EVENT, THE EVENT WAS DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798419 ↗
• InjuryApr 18, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED "NOT PICKING UP ECG WAVE FORMS, P WAVE SPECIFICALLY. CANNOT TELL IF IT'S THE SHERLOCK SENSOR OR THE PICC. AN ECHO WAS TAKEN DUE TO PATIENT SYMPTOMS AND SHOWED THE PICC TIP WAS IN THE RIGHT VENTRICLE."

  Patient problems: Unspecified Heart Problem

  MAUDE report 16765636 ↗
• 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 16715849 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER "PATIENT CODED OR HAD SHORTNESS OF BREATHE AFTER PLACING PICC LINE IN IR SUITE". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Dyspnea

  MAUDE report 16715490 ↗

Other Bard Access Systems, Inc. products

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• 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