PowerPICC Provena SOLORecalls & reported problems across all models

We found 19 models of PowerPICC Provena SOLO by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 201 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2018 and May 27, 2026 — classified as 18 injuries, 183 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (69 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 Provena SOLO 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 8 of these models · Recall details · FDA record ↗

2. 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-2664-2026 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗

Most reported PowerPICC Provena SOLO problems

PowerPICC Provena SOLO models

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

• PowerPICC Provena SOLO S1395108D5

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall39 reports
• PowerPICC Provena SOLO S1395108D2

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall32 reports
• PowerPICC Provena SOLO S1395108D3

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall28 reports
• PowerPICC Provena SOLO S1395108D4

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall27 reports
• PowerPICC Provena SOLO S1295108FD3

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall12 reports
• PowerPICC Provena SOLO S1295108FD5

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall11 reports
• PowerPICC Provena SOLO S1295108FD1

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall4 reports
• PowerPICC Provena SOLO S1395108D1

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall4 reports
• PowerPICC Provena SOLO CK000884A

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall0 reports
• PowerPICC Provena SOLO CK001000

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall0 reports
• PowerPICC Provena SOLO CK000525B

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 recall0 reports
• PowerPICC Provena SOLO S1295108FD2

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  17 reports
• PowerPICC Provena SOLO S1295108FD4

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  10 reports
• PowerPICC Provena SOLO CK000409A

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  7 reports
• PowerPICC Provena SOLO CK000931A

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  6 reports
• PowerPICC Provena SOLO CK000610A

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 report
• PowerPICC Provena SOLO CK001031

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 report
• PowerPICC Provena SOLO S1294108D7

  Catheter, intravascular, therapeutic, long-term greater than 30 days
  1 report
• PowerPICC Provena SOLO S1395108D7

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

Recent PowerPICC Provena SOLO adverse event reports

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

• MalfunctionMay 27, 2026Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT RESISTANCE MET WHILE RETRACTING GUIDEWIRE. WHEN REMOVED, THE WIRE WAS UNCOILED.

  Patient problems: Insufficient Information

  MAUDE report 25300788 ↗
• MalfunctionApr 21, 2026Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED BY THE CUSTOMER THAT TIP OF THE SHEATH PEELED WHEN TRYING TO INSERT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947627 ↗
• MalfunctionApr 6, 2026Crack

  IT WAS REPORTED, PLACED A PICC SUCCESSFULLY THEN THEY HAD NO BLOOD RETURN AND NOTICED AIR IN SYRINGE. THEY REALIZED THERE WAS A CRACK IN THE RED HUB. IT WAS LEAKING SALINE WHEN FLUSHED. PLACED A NEW PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791911 ↗
• MalfunctionMar 25, 2026Material Deformation

  IT WAS REPORTED QUIT A FEW INTRODUCER/DILATOR MALFUNCTIONS LATELY WHERE THE GRAY PORTION OF THE INTRODUCER BUNCHING UP WHEN TRYING TO INSERT IT INTO THE ARM. NO FURTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686466 ↗
• MalfunctionMar 25, 2026Material Deformation

  IT WAS REPORTED THE GRAY PORTION OF THE INTRODUCER BUNCHING UP WHEN TRYING TO INSERT IT INTO THE ARM. PATIENT EXPERIENCED PAIN THAT REQUIRED ADDITIONAL LIDOCAINE BEFORE PROCEEDING WITH A NEW INTRODUCER/DILATOR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 24686433 ↗
• MalfunctionMar 24, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED ACCORDING TO BEDSIDE RN, HUB JUST POPPED OFF. PICC DISCONTINUED. UNABLE TO PLACE NEW PICC IN OPPOSITE ARM, MULTIPLE PERIPHERALS PLACED. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675831 ↗
• MalfunctionJan 5, 2026Activation Problem

  IT WAS REPORTED THAT SAFETY LOCK MECHANISM SLIDES OFF THE NEEDLE AND BECOMES A NEEDLE STICK HAZARD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958411 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED RUPTURE AT THE END OF THE CATHETER THAT CAUSED THE INFILTRATION. PATIENT EXPERIENCED OOZING, PAINFUL AND TENDERNESS, AND INFILTRATION AT THE CATHETER SITE. CATHETER WAS REMOVED SUCCESSFULLY WITHOUT ADDITIONAL INTERVENTION. LEAK WAS SUBCUTANEOUS. NO PIECE WAS LEFT IN THE PATIENT. A PERIPHERAL CATHETER WAS PLACED. EVENT INTERRUPTED IV ANTIBIOTICS. PATIENT RECEIVED CEFTRIAXONE, HYDROCORTISONE, METRONIDAZOLE, POTASSIUM CHLORIDE, AND VANCOMYCIN. THERE WAS NO SERIOUS PATIENT HARM.

  Patient problems: Extravasation; Fluid Discharge; Pain

  MAUDE report 23698340 ↗
• MalfunctionOct 21, 2025Product Quality Problem; Defective Component; Product Quality Problem; Defective Component

  IT WAS REPORTED THE STYLET WAS WITHIN THE PICC CATHETER UPON OPENING BUT THE RUBBER STOPPER T CONNECTER WAS NOT. THE KIT WAS UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352130 ↗
• MalfunctionOct 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED A WIRE WAS FOUND INSIDE ONE OF THE LUMENS OF THE CATHETER. THE METAL OBJECT WAS NOTED AT THE END OF THE PICC LINE INSERTION AND BEFORE THE INITIAL DRESSING WAS APPLIED. THE STYLE WIRE WAS INTACT WHEN REMOVED. THE CONCERN WAS A METAL OBJECT NOTED INTERNALLY, IN THE WHITE PORT (PIGTAIL)OF THE PICC. THIS WAS NEAR THE AREA WHERE THE WHITE PIGTAIL MEETS THE PURPLE PLATFORM. THE PICC LINE WAS REMOVED, AND THE PATIENT REQUIRED AN ADDITIONAL PICC LINE TO PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288970 ↗
• MalfunctionJul 31, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN OPENING KIT TO PLACE PICC, THERE WAS A HAIR FOUND ON TOP OF THE ENCLOSED STERILE GOWN. UPON FURTHER INSPECTION, THERE WERE NO OTHER HAIRS FOUND ANYWHERE WITHIN THE KIT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22682553 ↗
• MalfunctionJul 29, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT SAFETY MECHANISM FAILED TO REMAIN ON NEEDLE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22654261 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD A LEAKING PICC. IT WAS LEAKING DOWN FROM THE HUB WHEN THEY FLUSHED IT WITH SALINE. PICC REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22444416 ↗
• MalfunctionJul 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT SEALED LOT SAMPLE RETURNED WITH CONFIRMED SPLIT SHEATH TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396235 ↗
• MalfunctionJul 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, FOUR SEALED LOT SAMPLES RETURNED WITH CONFIRMED ABRUPT TRANSITION BETWEEN THE INTRODUCER SHEATH AND THE DILATOR. THIS REPORT ADDRESSES ALL FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387166 ↗

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