PowerPICC Provena SOLO S1395108D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741155123), received between Apr 17, 2019 and Mar 25, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (12 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 27 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionMar 11, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE INTRODUCER COVER HANDLE CAME DETACHED FROM PEEL AWAY COVER. NO HARM WAS DONE TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574470 ↗
• MalfunctionMar 5, 2025Activation Problem; Activation Problem

  IT WAS REPORTED; THE SAFETY FELL OFF THE SECURELOC INTRODUCER NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528276 ↗
• MalfunctionAug 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A BUG IN 3 KITS. ADDITIONAL INFORMATION RECEIVED 09 AUGUST 2023: DID NOT USE ON THE PATIENT. LOOKS LIKE IT IS WITH THE STERILE SALINE FLUSHES. NO DIRECT PATIENT USE, NO LIFE THREATENING SITUATION, NO PATIENT HARM OR INTERRUPTION OF MEDS. THIS REPORT ADDRESSES THE THIRD KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557980 ↗
• MalfunctionAug 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A BUG IN 3 KITS. ADDITIONAL INFORMATION RECEIVED 09 AUGUST 2023: DID NOT USE ON THE PATIENT. LOOKS LIKE IT IS WITH THE STERILE SALINE FLUSHES. NO DIRECT PATIENT USE, NO LIFE THREATENING SITUATION, NO PATIENT HARM OR INTERRUPTION OF MEDS. THIS REPORT ADDRESSES THE SECOND KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557979 ↗
• MalfunctionAug 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS BUG INSIDE THE PACKAGING. NO INJURIES OR ADVERSE EVENT. ADDITIONAL INFORMATION RECEIVED 07 AUGUST 2023: THIS ITEM WAS FOUND AND NOT USED ON ANY PATIENT. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557978 ↗
• MalfunctionAug 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS BUG INSIDE THE PACKAGING. NO INJURIES OR ADVERSE EVENT. ADDITIONAL INFORMATION RECEIVED 07 AUGUST 2023: THIS ITEM WAS FOUND AND NOT USED ON ANY PATIENT. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557977 ↗
• MalfunctionAug 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS BUG INSIDE THE PACKAGING. NO INJURIES OR ADVERSE EVENT. ADDITIONAL INFORMATION RECEIVED 07 AUGUST 2023: THIS ITEM WAS FOUND AND NOT USED ON ANY PATIENT. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557976 ↗
• MalfunctionAug 15, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A BUG IN 3 KITS. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023: DID NOT USE ON THE PATIENT. LOOKS LIKE IT IS WITH THE STERILE SALINE FLUSHES. NO DIRECT PATIENT USE, NO LIFE THREATENING SITUATION, NO PATIENT HARM OR INTERRUPTION OF MEDS. THIS REPORT ADDRESSES THE FIRST KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550488 ↗
• MalfunctionMar 24, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT "PLACER NOTED LEAKING OF FLUID AND BLOOD FROM THE YELLOW STOPPER END WHERE THE STYLET PASSES THROUGH TO THE PICC. PLACER ALSO NOTED AIR ENTERING LINE THROUGH THE SAME AREA WHEN DRAWING THROUGH. THIS ISSUE WAS NOTICED DURING INSERTION OF OUR TL SOLO PICC. THERE WAS NO PATIENT IMPACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616265 ↗
• MalfunctionAug 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY TM ¿CUSTOMER REPORTS HOLE IN PICC JUST AFTER 6CM MARK. RN THAT ADDRESSED THE PROBLEM STATED ¿THE FOLLOWING DAY BEFORE I WAS ASKED TO GET LABS FROM THE PICC, WHITE AND GREW LUMENS WERE INFUSING, THE RED LUMEN WAS FREE, HARD TO FLUSH AND NO BLOOD RETURNS. THE NURSE SAID SHE WAS GOING TO CALL THE DOCTOR AND WOULD ALTEPLASE IT. SHE SAID IT CLOTTED BY THEN SO WAS VERY HARD TO GET THE ALTEPLASE IN. THE NURSE GOT A HOLD OF CLINICIAN, AND I WENT AND FLUSHED THE WHITE AND GREY LUMENS AND HAD GOOD BLOOD RETURNS, THEN FLUSHED THE RED LUMEN AND PATIENT COMPLAINED OF BURNING WITH THE FLUSH. I HAD ALSO COMPLETED A DRESSING CHANGE PRIOR TO FLUSHING BECAUSE PATENT WAS BLEEDING AFTER THE RETRACTION. AFTER FLUSHING, DRESSING WAS FULL OF FLUID SO DOCTOR WAS CONTACTED AND THEY INSTRUCTED TO PULL PICC AND PLACE A PIV."

  Patient problems: Pain

  MAUDE report 15165441 ↗
• MalfunctionAug 4, 2022Failure to Infuse; Device Dislodged or Dislocated; Failure to Infuse; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE NIGHT NURSE HAD A CXR DONE AND IT WAS DEEP RADIOLOGY SO SAID TO RETRACT 5CM, SHE RETRACTED 4CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165378 ↗
• MalfunctionJun 30, 2022Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH "WHILE ATTEMPTING TO INSERT THE INTRODUCER/DILATOR, I MET AN UNUSUAL AMOUNT OF RESISTANCE. I RETRACTED THE INTRODUCER/DILATOR AND NOTED A DEFECT IN THE GRAY PORTION OF THE DEVICE - WHERE IT MEETS THE WHITE TIP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876111 ↗
• MalfunctionMay 21, 2022Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH, "THEY HAVE BEEN CHECKING STYLETS OVER WHEN REMOVING THE PICCS. NOTICED A BEND IN WIRE BUT NO DIFFICULTIES WITH INSERTION." ADDITIONAL INFO. RECEIVED 12/15/2021: WHAT TYPE OF CATHETER SECUREMENT WAS USED? STATLOCK. ON 04/27/2022 - THE RETURNED SAMPLE EXHIBITED MULTIPLE BENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465316 ↗
• MalfunctionApr 15, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "STYLET ISSUE. IT WAS SEVERELY KINKED AFTER PICC WAS INSERTED. THIS PARTICULAR PATIENT WAS A FAILED CATHETER ATTEMPT, IT WOULD NOT ADVANCE. PT WAS A 65 YO MALE WITH A RIGHT HUMERUS FRACTURE. ATTEMPT WAS MADE TO LEFT ARM, BRACHIAL VEIN, VEIN WAS A 0.5CM DIAMETER AT INSERTION SITE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117553 ↗
• MalfunctionApr 8, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "STYLET WIRE WAS BENT/KINKED COMING OUT OF THE PACKAGE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053576 ↗
• MalfunctionApr 8, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "STYLET CHECKED PRIOR TO INSERTION. PICC INSERTED IN PT.'S LEFT ARM, SOME MINOR INSERTION DIFFICULTY NOTED ADVANCING PAST SUBCLAVIAN AREA, RESOLVED EASILY WITH REPOSITIONING PT.'S LEFT ARM. STYLET CHECKED UPON REMOVAL FROM PICC AFTER PICC SUCCESSFULLY INSERTED AND KINK NOTED WITHIN LAST 2CM OF STYLET (RECOGNIZED VISUALLY AND TACTILELY)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053573 ↗
• MalfunctionApr 8, 2022Material Deformation; Material Deformation

  IT WAS REPORTED VIA INVESTIGATION "STYLET WIRE WAS BENT/KINKED COMING OUT OF THE PACKAGE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053571 ↗
• MalfunctionApr 8, 2022Material Deformation; Material Deformation

  IT WAS REPORTED VIA INVESTIGATION "STYLET WIRE WAS BENT/KINKED COMING OUT OF THE PACKAGE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052620 ↗
• MalfunctionApr 6, 2022Defective Component; Defective Component

  IT WAS REPORTED "WHEN PICC WAS BEING REMOVED FROM PATIENT, RN NOTICED A BUMP IN THE PICC TOWARDS THE END OF THE PICC." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14030502 ↗
• MalfunctionMar 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "STYLET HAD VISIBLE BEND/KINK NEAR THE END POST INSERTION. THIS WAS NOT PRESENT PRIOR TO INSERTION. THERE WERE NO ISSUES ADVANCING PICC DURING THE INSERTION PROCESS. NO HARM BUT REPORTED FOR POTENTIAL HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13724743 ↗
• MalfunctionFeb 28, 2022Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED THAT USER COULD NOT GET THE INTERNAL ECG TO WORK AT ALL DESPITE PROBLEM SOLVING. THERE WERE NO INSERTION COMPLICATIONS BUT THERE IS A SLIGHT KINK/BEND IN THE STYLET ALSO. NO PATIENT HARM BUT REPORTED PATIENT IS COVID POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625564 ↗
• MalfunctionFeb 24, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "STYLET WIRE WAS BENT/KINKED COMING OUT OF THE PACKAGE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596104 ↗