PowerPICC Provena SOLO S1395108D2Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741154911), received between Nov 25, 2019 and Apr 21, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (17 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. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 29, 2025Activation Problem; Activation Problem

  IT WAS REPORTED " THE NEEDLE DID NOT SAFETY. GREEN TOP CAME COMPLETELY OFF WHEN I ATTEMPTED TO SAFETY THE NEEDLE LEAVING THE SHARP EXPOSED". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111046 ↗
• MalfunctionMar 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN FLUSHED TRIPLE LUMEN PICC LEAKING AT INSERTION SITE. SUBCUTANEOUSLY RUPTURED IN ONE OF THE LUMENS AT THE 3CM MARK. CATHETER REMOVED, AND PATIENT WAS DISCHARGED HOME THE NEXT DAY. A PIV WAS PLACED PRIOR TO DISCHARGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590629 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED PICC RN NOTIFIED THAT THE SOLO VALUE ON THE MIDDLE LUMEN TUBING CAME APART. THE LINE WAS PLACED 3 DAYS PRIOR WITH NO ISSUES. UNKNOWN WHAT HAPPENED. NO FURTHER INFORMATION PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363942 ↗
• MalfunctionFeb 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THE CUSTOMER REACHED OUT THAT THEY FOUND SOMETHING IN THE PICC KIT PRIOR TO INSERTION THEY THOUGHT IT MIGHT BE MOLD OR SOMETHING. THIS WAS NOT USED ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329220 ↗
• MalfunctionMay 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER RN STATED THAT SHE HAS NOTICED THAT THE PICC WIRES HAD A BEND TO THEM (RIGHT IN THE MIDDLE). SHE HAS NOT SAVED THE LOT NUMBERS FOR THOSE LINES BUT DID SAVE A RECENT ONE FOR ME. NO OTHER INFO AT THIS TIME. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. 04/29/2024: INSPECTION OF THE STYLET REVEALED A KINK IN THE POLYIMIDE COATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382569 ↗
• MalfunctionJun 16, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "LEAKING FROM AROUND WIRE AND RUBBER PORT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17146452 ↗
• MalfunctionOct 4, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE RN "AN INTRODUCER WOULD NOT GO INTO THE VEIN. YOU CAN SEE ON THE END OF THE DARK GREY IT BUCKLED". NO FURTHER INFORMATION ON AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540881 ↗
• MalfunctionSep 8, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED BY TM "NURSE REPORTED THE FOLLOWING "SILVER OF RED MATERIAL ON DILATOR DID NOT BREAK ALL THE WAY, CAUSING PLASTIC PIECE TO BE WRAPPED ALL THE WAY AROUND THE PICC LINE. HAD TO PRESS DILATOR AGAINST THE HUB TO FINALLY BREAK APART THE DILATOR RED PIECE." NURSE REPORTS BEING ABLE TO REMOVE THE MATERIAL OFF THE PICC WITHOUT DAMAGING THE PICC LINE. NO HARM TO PATIENT WAS REPORTED BY THE RN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15384968 ↗
• MalfunctionAug 31, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED "WHEN ON THE STEP OF BREAKING THE BREAKAWAY SHEATH, THE RED HARD PLASTIC PIECE BROKE AWAY FROM THE GREY RUBBER PIECE. THE WHOLE SHEATH WAS ABLE TO BE REMOVED FROM PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327703 ↗
• MalfunctionDec 1, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER "WHEN INSERTING THE DILATOR THE INNER PORTION OF THE DILATOR (IN BETWEEN THE WHITE AND GRAY) WAS STIFF AND RIGID, CAUSING IT TO CATCH ON THE SKIN THAT THEN CAUSED BENDING OF THE DILATOR. THIS RESULTED IN HER HAVING TO DROP AN ADDITIONAL DILATOR ONTO THE STERILE FILED. NO HARM WAS MADE TO THE PATIENT." IT WAS REPORTED "THIS CAUSES HER TO HAVE TO NICK THE SKIN TO ALLOW THE DILATOR TO GO IN, AND MANY TIMES THIS CAUSES SEVERE BLEEDING AROUND INSERTION SITE. WHEN SEVERE BLEEDING OCCURS THE CUSTOMER REPORTS MAJOR CONCERNS FOR INFECTION DUE TO THEM HAVING TO REDRESS THE SITE 24 HOURS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913206 ↗
• MalfunctionSep 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PICC TEAM AT THE HOSPITAL HAS EXPERIENCED ISSUES WITH THE MICROINTRODUCERS BEING RIGID, CATCHING ONTO THE SKIN, AND THE TIP OF THE INTRODUCER BENDING FOR THE PAST 1.5 WEEKS (ESTIMATED TIME FRAME OF AUGUST 11TH-22ND). THEY ESTIMATED THAT THIS HAS HAPPENED AROUND 7 TIMES DURING THAT WEEK IN A HALF TIME. NO INTRODUCERS WERE SAVED AND ONLY ONE LOT NUMBER WAS PROVIDED FROM THIS TEAM. NO IMPACT TO PATIENT. THIS REPORT ADDRESSES THE SIXTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490626 ↗
• MalfunctionSep 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PICC TEAM AT THE HOSPITAL HAS EXPERIENCED ISSUES WITH THE MICROINTRODUCERS BEING RIGID, CATCHING ONTO THE SKIN, AND THE TIP OF THE INTRODUCER BENDING FOR THE PAST 1.5 WEEKS (ESTIMATED TIME FRAME OF AUGUST 11TH-22ND). THEY ESTIMATED THAT THIS HAS HAPPENED AROUND 7 TIMES DURING THAT WEEK IN A HALF TIME. NO INTRODUCERS WERE SAVED AND ONLY ONE LOT NUMBER WAS PROVIDED FROM THIS TEAM. NO IMPACT TO PATIENT. THIS REPORT ADDRESSES THE FIFTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490625 ↗
• MalfunctionSep 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PICC TEAM AT THE HOSPITAL HAS EXPERIENCED ISSUES WITH THE MICROINTRODUCE'S BEING RIGID, CATCHING ONTO THE SKIN, AND THE TIP OF THE INTRODUCER BENDING FOR THE PAST 1.5 WEEKS (ESTIMATED TIME FRAME OF AUGUST 11TH-22ND). THEY ESTIMATED THAT THIS HAS HAPPENED AROUND 7 TIMES DURING THAT WEEK IN A HALF TIME. NO INTRODUCERS WERE SAVED AND ONLY ONE LOT NUMBER WAS PROVIDED FROM THIS TEAM. NO IMPACT TO PATIENT. THIS REPORT ADDRESSES THE SEVENTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490589 ↗
• MalfunctionSep 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PICC TEAM AT THE HOSPITAL HAS EXPERIENCED ISSUES WITH THE MICROINTRODUCERS BEING RIGID, CATCHING ONTO THE SKIN, AND THE TIP OF THE INTRODUCER BENDING FOR THE PAST 1.5 WEEKS (ESTIMATED TIME FRAME OF AUGUST 11TH-22ND). THEY ESTIMATED THAT THIS HAS HAPPENED AROUND 7 TIMES DURING THAT WEEK IN A HALF TIME. NO INTRODUCERS WERE SAVED AND ONLY ONE LOT NUMBER WAS PROVIDED FROM THIS TEAM. NO IMPACT TO PATIENT. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490334 ↗
• MalfunctionSep 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PICC TEAM AT THE HOSPITAL HAS EXPERIENCED ISSUES WITH THE MICROINTRODUCER'S BEING RIGID, CATCHING ONTO THE SKIN, AND THE TIP OF THE INTRODUCER BENDING FOR THE PAST 1.5 WEEKS (ESTIMATED TIME FRAME OF AUGUST 11TH-22ND). THEY ESTIMATED THAT THIS HAS HAPPENED AROUND 7 TIMES DURING THAT WEEK IN A HALF TIME. NO INTRODUCERS WERE SAVED AND ONLY ONE LOT NUMBER WAS PROVIDED FROM THIS TEAM. NO IMPACT TO PATIENT. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490326 ↗
• MalfunctionSep 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PICC TEAM AT THE HOSPITAL HAS EXPERIENCED ISSUES WITH THE MICROINTRODUCERS BEING RIGID, CATCHING ONTO THE SKIN, AND THE TIP OF THE INTRODUCER BENDING FOR THE PAST 1.5 WEEKS (ESTIMATED TIME FRAME OF AUGUST 11TH-22ND). THEY ESTIMATED THAT THIS HAS HAPPENED AROUND 7 TIMES DURING THAT WEEK IN A HALF TIME. NO INTRODUCERS WERE SAVED AND ONLY ONE LOT NUMBER WAS PROVIDED FROM THIS TEAM. NO IMPACT TO PATIENT. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490305 ↗
• MalfunctionSep 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PICC TEAM AT THE HOSPITAL HAS EXPERIENCED ISSUES WITH THE MICROINTRODUCERS BEING RIGID, CATCHING ONTO THE SKIN, AND THE TIP OF THE INTRODUCER BENDING FOR THE PAST 1.5 WEEKS (ESTIMATED TIME FRAME OF AUGUST 11TH-22ND). THEY ESTIMATED THAT THIS HAS HAPPENED AROUND 7 TIMES DURING THAT WEEK IN A HALF TIME. NO INTRODUCERS WERE SAVED AND ONLY ONE LOT NUMBER WAS PROVIDED FROM THIS TEAM. NO IMPACT TO PATIENT. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490289 ↗
• MalfunctionSep 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "CLINICIAN OBSERVED THAT WHEN INSERTING THE DILATOR, THE INNER PORTION OF THE DILATOR (WHITE PORTION) WAS ALMOST RIGID AND BECAUSE OF THAT IT WAS CATCHING ONTO THE SKIN AND THE TIP OF THE INTRODUCER WAS BENDING. HE REPORTED THAT THIS NEVER CAUSED PAIN OR INJURY TO THE PATIENTS SKIN. IN RESULT, THIS REQUIRED THE CLINICIAN TO HAVE TO OPEN A NEW DILATOR KIT AND DROP IT ON HIS STERILE FIELD. THE CLINICIANS REPORTED THAT THE TIP OF THE INTRODUCER FELT DULL AND NOT WHAT THE NORMAL DILATOR FEELS LIKE. NO IMPACT TO PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488906 ↗
• MalfunctionJul 16, 2021Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "THIS IS THE 3RD WIRE FRACTURE WE'VE HAD IN 2 MONTHS - ALSO THE ONLY 3 I HAVE EVEN HEARD OF IN MY 10 YEARS AS A PICC NURSE. PICC LINE NURSE NOTIFIED REPRESENTATIVE." THE OTHER TWO WIRES WERE ADDRESSED IN FDA REPORT NUMBERS 3006260740-2021-02272 AND 3006260740-2021-02273.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12182112 ↗
• MalfunctionJul 1, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "WHILE INSERTING THE PICC LINE THE NURSE MET SLIGHT RESISTANCE AND PULLED BACK THE WIRE AND RE-INSERTED AND MET SLIGHT RESISTANCE AND DECIDED TO PULL OUT. AFTER PULLING OUT THE SECOND TIME THE NURSE RECOGNIZED THAT PART OF THE WIRE HAD BROKEN OFF." ADDITIONAL INFORMATION RECEIVED 06/17/2021: NO PART OF THE WIRE WAS RETAINED IN THE PT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103679 ↗
• MalfunctionMay 21, 2021Material Frayed; Material Frayed

  IT WAS REPORTED UNEVENTFUL PICC PLACEMENT. UPON REMOVAL OF STYLET WIRE, IT WAS NOTED THAT IT WAS FRACTURED APPROX. 4CM FROM TIP. AFTER STERILE DRESSING WAS APPLIED AND PROCEDURE COMPLETED, WE ATTEMPTED TO FURTHER ASSES TIP WHEN IT COMPLETELY BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862869 ↗
• MalfunctionApr 23, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "WHILE PLACING A TRIPLE LUMEN PICC ON (B)(6) 2021 I NOTICED THE LINE WAS COILING AT ROUGHLY 35CM. AFTER INSPECTION OF THE LINE AND WIRE I NOTICED THE TIP OF THE WIRE WAS BENT, WHEN TOUCHED IT BROKE OFF ONTO THE STERILE DRAPE. NO VISIBLE SIGNS OF FRACTURE WERE SEEN PRIOR TO ATTEMPTED PLACEMENT. I SECOND KIT WAS OPENED FOR PLACEMENT WITH NO SIGNS OF FRACTURE IN THE WIRE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720381 ↗