PowerPICC Provena S1294108D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741154799), received between Mar 19, 2020 and Aug 19, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50323163 ↗
• MalfunctionJan 12, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT PICC KINKED UNDER THE SKIN THAT REQUIRED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239552 ↗
• InjuryJan 3, 2022Entrapment of Device; Material Fragmentation

  A POWERPICC PROVENA, POLYURETHANE PICC CATHETER WITH SOLO VALVE TECHNOLOGY WAS INSERTED ON (B)(6) 2021 USING LOT NUMBER REFW0154. THREE (3) LINEAR RADIOPAQUE FOREIGN BODIES ARE SEEN, ONE IN THE SVC/ATRIUM, ONE IN THE POSTERIOR RIGHT LIVER AND ONE IN THE RIGHT LOWER LOBE. THESE APPEAR TO REPRESENT WIRE FRAGMENTS. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13152031 ↗
• MalfunctionMar 19, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "WIRE BROKE AFTER REMOVED FROM PATIENT. WIRE BROKE WHEN PLACER TESTED INTEGRITY UPON REMOVAL OF THE WIRE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11528648 ↗
• MalfunctionJan 27, 2021Material Frayed; Difficult or Delayed Positioning; Material Fragmentation; Material Frayed; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED ¿LEFT BRACHIAL PICC PLACED WITH DIFFICULTY. ACCESSED VESSEL ON 3RD ATTEMPT. ARMS VERY OBESE. GUIDEWIRE PLACED EASILY THROUGH 21GA NEEDLE TO AT LEAST 20CMS WITH NO RESISTANCE. 4.5 MICRO-INTRODUCER/VEIN DILATOR PLACED OVER GUIDEWIRE. GUIDEWIRE REMOVED EASILY AND INTACT. CAPPED INTRODUCER WITH STERILE DEAD END CAP. UPON ADVANCING CATHETER RESISTANCE MET AT 12 CMS. CATHETER PULLED BACK EASILY AND CATHETER FLUSHED WITH SALINE WHILE ADVANCING CATHETER TO OPEN VALVE. AT 20CMS I MET THE SAME RESISTANCE. UPON TRYING TO PULL THE CATHETER BACK IT WAS CAUGHT IN THE VEIN (MOST LIKELY IN ANOTHER VALVE.) I WAITED 20 SECONDS AND WHILE FLUSHING CATHETER WAS ABLE TO PULL IT BACK AT LEAST 5 CMS. HOB REPOSITIONED, LEFT ARM PLACED PERPENDICULAR TO BODY TO OPEN UP AXILLA FOR BETTER CATHETER ADVANCEMENT, WITH ASSISTANCE ANOTHER NURSE PUSHED ON SHOULDER TOWARDS FEET (THIS WAS DONE TO OPEN UP THE PATHWAY FROM THE AXILLA TO THE SUBCLAVIAN VEIN) NO FURTHER RESISTANCE MET AND CATHETER ADVANCED EASILY WHILE FLUSHING WITH NS. PER 3CG TECHNOLOGY SPIKED P WAVES INDICATED TIP AT CAJ. UPON REMOVING INTERNAL STYLET (IT FELT SLUGGISH TO PULL OUT OF THE CATHETER) THERE WAS NO RESISTANCE AT ANY TIME DUR

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11236499 ↗
• MalfunctionOct 14, 2020Material Twisted/Bent

  IT WAS REPORTED THE PICC WAS PLACED ON (B)(6) AND CXR WAS TAKEN FOR OTHER REASONS, PICC HAD BLOOD RETURN AND WAS FLUSHING. RADIOLOGIST NOTICED THE PICC HAD LOOPED BACK ON ITSELF IN THE SVC BY ABOUT 2 CM¿S. NURSE WENT UP TO PULL THE PICC BACK 2 CM¿S TO SEE IF IT WOULD ALLOW FOR THE TIP TO DROP. THERE IS CONCERN ABOUT PICC STILL BEING BENT. AGAIN, PICC STILL WORKING FINE AFTER PULL BACK, HOWEVER THIS DIDN¿T SEEM NORMAL TO THE NURSE. NO PATIENT HARM. THEY ARE STILL WAITING TO SEE IF THEY ARE GOING TO PULL THE PICC OR LEAVE IT IN? WAITING ON DOCS ORDERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10681068 ↗
• MalfunctionMay 7, 2020Material Frayed; Material Frayed

  IT WAS REPORTED "NITINOL WIRE BROKEN. NOTICED WHEN PULLING LINE FROM PATIENT. FAILED PLACEMENT. " 04/20/2020-ADDITIONAL INFORMATION RECEIVED STATED, "PICC ATTEMPT WAS MADE AND IT WOULD NOT THREAD. WHEN PICC WAS PULLED OUT WITH WIRE IN PLACE WIRE NOTICED TO BE BROKEN AT DISTAL TIP."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10032042 ↗
• MalfunctionMar 19, 2020Material Frayed; Material Frayed

  IT WAS REPORTED "NITINOL WIRE BROKEN IN HALF PRIOR TO PULL FROM SLEEVE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9856592 ↗