PowerPICC Provena S1294108D2Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741154898), received between Jul 23, 2020 and May 13, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (14 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-2664-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Material Deformation

  IT WAS REPORTED MICRO INTRODUCER COLLAPSED UPON ENTRY INTO VEIN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162894 ↗
• MalfunctionApr 23, 2026Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE WHITE AND GRAY PIECE OF THE INTRODUCER WASN'T SMOOTH. UPON INSPECTION, THERE WAS DAMAGE TO GRAY PIECE OF THE INTRODUCER AND PIECE WAS BROKEN OFF. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965845 ↗
• MalfunctionJan 5, 2026Contamination /Decontamination Problem

  IT WAS REPORTED HAIR NOTED ON PICC TRAY WHEN OPENED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959659 ↗
• MalfunctionMay 28, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE WIRE BENDS LIKE IT'S CUT. MADE THREADING THE PICC DIFFICULT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098735 ↗
• MalfunctionJan 6, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE GREEN SAFETY NEEDLE IN THE 4FR DUAL LUMEN PICC KITS ARE NOT LOCKING CORRECTLY. STATES THEY HAVE HAD ABOUT 5 KITS THAT HAD A FAULTY NEEDLE. STATES WHEN THEY SLIDE THE GREEN SAFETY UP, IT DOESN'T LOCK AND SLIDES RIGHT OFF THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES ALL 5 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21086154 ↗
• MalfunctionOct 30, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED BY THE CUSTOMER "COULD NOT GET SHERLOCK TO ADEQUATELY PICK UP AND ECG HAD NO WAVEFORM AT ALL. THE ONLY WAVEFORM CHANGE WAS WHEN I FLUSHED THE PICC, THE WAVEFORM JUMPED ALL THE WAY UP TO THE TOP BUT WHEN I QUIT FLUSHING IT WAS A STRAIGHT LINE AGAIN. I ORDERED A CHEST X-RAY FOR TIP PLACEMENT. PATIENT REQUIRED LONGER PROCEDURE TIME AND UNNECESSARY X-RAY EXPOSURE BUT NO HARM." 10/7/2024 - THE STYLET RETURNED FOR EVALUATION WAS FOUND TO BE KINKED AT THE DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569542 ↗
• MalfunctionApr 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "THE RUBBER PIECE THAT HOLDS THE TECHNOLOGY WIRE, THE HOLE IS TOO BIG. IT SUCKS AIR IN AND FLUID COMES OUT. THIS ACCOUNT HAS SEEN THIS SAME PROBLEM OCCUR ON ALL CONFIGURATIONS OF THEIR PROVENA SOLO PICCS." 03/24/2023 ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE WAS A PICC PLACEMENT. THE PROCEDURE WAS ABLE TO BE COMPLETED. IF YOU PLACE YOUR FINGER OVER THE LARGE HOLE IT STOPS THE AIR FROM SUCKING IN/FLUID FROM COMING OUT. THERE WAS NO PATIENT HARM. THE EVENT DID NOT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT. THERE WERE NO ADDITIONAL, UNPLANNED MEDICAL OR SURGICAL INTERVENTION (E.G., ADDITIONAL/ALTERNATIVE MEDICATIONS, IMAGING, ETC.) REQUIRED TO AVOID PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714979 ↗
• MalfunctionMar 8, 2023Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT "SHE FEELS LIKE WITH DUAL LUMEN 4 FRENCH PICC LINE THE STOPPER HOLE IS TOO LARGE AND COULD BE SUCKING IN AIR DURING TROUBLE SHOOTING WHILE PLACING A PICC. WHEN FLUSHING THEY SEE FLUID LEAK OUT OF THE STOPPER." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506993 ↗
• MalfunctionJan 5, 2023Defective Component; Material Deformation; Defective Component; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "A PIECE OF THE RUBBER PORTION OF THE WIRE COME OFF. IT IS THE STOPPER FOR THE WIRE THAT GUIDES IT IN THE PICC. NO ISSUES RELATED TO THE PICC WIRE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109652 ↗
• MalfunctionNov 8, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED VIA MEDWATCH "DURING PICC INSERTION THERE WAS DIFFICULTY ADVANCING PICC AND IT COILED IN THE VEIN. AFTER PICC INSERTION WAS ABORTED, THE STYLET WAS ASSESSED AND NOTED THAT THERE WAS A SIGNIFICANT KINK/BEND IN THE STYLET." ADDITIONAL INFORMATION RECEIVED 10/25/2022: WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. NO WHAT THEY¿RE BEING TREATED FOR: NECROTIZING SOFT TISSUE INFECTION IN ABDOMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756556 ↗
• MalfunctionOct 27, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE STYLET KINKED DURING INSERTION. CUSTOMER STATED STYLET KINKED DURING INSERTION BUT DID NOT MEET RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686299 ↗
• MalfunctionJul 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "PICC PLACED ON (B)(6) 2021, LEFT ARM 41CM CATHETER LENGTH, PICC FLUSHED AND WORKED FINE. NEXT DAY IT WASN'T WORKING SO A CXR WAS PERFORMED WHICH SHOWED A KINK IN THE LINE NEAT THE 5-6CM MARK. RN RETRACTED THE PICC BUT WHEN THE KINK RELEASED THE TIP WAS IN A SUB OPTIMAL LOCATION SO THEY REPLACED THE LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246226 ↗
• MalfunctionJul 16, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "FRACTURED PICC 3CG WIRE." ADDITIONAL INFORMATION RECEIVED 06/28/2021. WAS THERE ANY PATIENT HARM REPORTED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12183458 ↗
• MalfunctionFeb 4, 2021Break; Physical Resistance/Sticking

  IT WAS REPORTED "THE WIRE BROKE OFF FROM ONE OF OUR PICC TRAYS AND THE HOSPITAL WAS CURIOUS TO KNOW IF THIS WAS A TECHNIQUE ISSUE WITH A NEW NURSE OR A MANUFACTURER ISSUE." ADD INFO RCVD 01/13/2020: THE PICC NURSE WAS ATTEMPTING TO GUIDE THE CATHETER DOWN THE INTRODUCER AND KEPT GETTING RESISTANCE. THE PICC NURSE MADE SEVERAL ATTEMPTS TO GET THE PICC LINE DOWN AND KEPT GETTING GREAT RESISTANCE. THE PICC NURSE PULLED THE PICC CATHETER OUT AND TRIED TO PULL THE ECG TRACING WIRE BACK AND THAT¿S WHEN THEY REALIZED THE TIP OF THE WIRE HAD BROKEN AND WAS STILL WITHIN THE PICC CATHETER. THE PICC NURSE PULLED THE BROKE PIECE OUT OF THE CATHETER AND THE REST OF THE ECG TRACING WIRE WAS SECURELY IN THE PICC CATHETER. THIS CATHETER WAS DISCARDED. PLACEMENT INFO: RIGHT BRACHIAL. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: THIS CATHETER WAS REMOVED IMMEDIATELY AND WAS NEVER SECURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11282532 ↗
• MalfunctionOct 2, 2020Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH "PICC INSERTED ON (B)(6) 2020 BECAME COMPLETELY OCCLUDED. AM CHEST X-RAY SHOWED PICC TO BE IN CORRECT POSITION IN SVC. OBTAINED AN X-RAY OF THE UPPER ARM AND A LOOP COULD BE SENT IN THE ARM ABOUT 10CM FROM THE ". ADD INFO RCVD: 09/10/2020: "DL PICC INSERTED (B)(6) 2020, REF# (B)(4), LOT#REDX1880, AND BECAME COMPLETED OCCLUDED TODAY. AM CHEST X-RAY SHOWED PICC TO BE IN CORRECT POSITION IN THE SVC. OBTAINED AN X-RAY OF THE UPPER ARM AND A LOOP COULD BE SEEN IN THE ARM ABOUT 10CM FROM THE HUB OF THE PICC CATHETER. THIS IS THE SECOND PICC CATHETER FOR THIS PATIENT. THE CATHETER WAS EXCHANGED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10621630 ↗
• MalfunctionOct 2, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THE PICC OCCLUDED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2020: REPLACED TL WITH DL AFTER CHEST X-RAY REVEALED PICC TIP IN RT BRACHIAL CEPHALIC VEIN. CHEST X-RAY OBTAINED BECAUSE ALL THREE PORTS WERE REPORTED TO BE OCCLUDED AFTER RECENTLY BEING TREATED WITH ACTIVASE. THE EXTERNAL LENGTH APPEARED TO BE AT THE SAME EXTERNAL LENGTH AS THE ORIGINAL PLACEMENT, AT 0

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10621625 ↗
• MalfunctionOct 2, 2020Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH "PICC WAS POSITIONAL. IT WOULD ONLY FLUSH AND DRAW BACK BLOOD IF ARM WAS RAISED ABOVE HEAD. UPON ASSESSMENT, WHEN ARM WAS RAISED AND RETRACTED PICC 2CM, IT HAD A GOOD BLOOD RETURN AND FLUSH. PICC WAS UNABLE TO FLUSH OR DRAW BLOOD WHEN ARM WAS RETURNED DOWN TO SIDE. CHEST X-RAY SHOWED NO KINK IN CATHETER. SUSPECTED KINK IN CATHETER IN ARM, DOUBLE LUMEN, WAS SAME LOT NUMBER AS PREVIOUS PICCS THAT WE SUSPECTED KINKED IN THE OTHER PT ARM".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10620557 ↗
• MalfunctionSep 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THE DOUBLE LUMEN PICC KINKED. IT WAS REMOVED AND REPLACED. "VEIN: BAS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10583936 ↗
• MalfunctionSep 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED BEDSIDE NURSE REPORTS THAT ON DAY ONE PUMP CONTINUED TO ALARM WHEN PATIENT WAS RECEIVING CHEMO AND IT WAS DIFFICULT TO OBTAIN BLOOD SAMPLE. THIS WAS REPORTED TO THE VAT THE DAY AFTER INSERTION. CHEST X-RAY AND X-RAY OF THE ARM WERE OBTAINED AND A KINK IN THE ARM WAS DETECTED. DL PICC WAS REPLACED WITH A TL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10490949 ↗
• MalfunctionSep 3, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THE PICC WAS "PLACED 7/3 AT 16:10, DID NOT USE IT. AT 18:30, RN COMPLAINED UNABLE TO FLUSH. UPON ASSESSMENT, IT WOULD NOT FLUSH. AFTER APPLYING MANUAL PRESSURE TO SITE, IT FLUSHED WELL. PICC RETRACTED 2 CM AND FLUSHED WELL. LATER, NIGHT RN HAD DIFFICULTY AND APPLIED COBAN AROUND SITE AND CATHETER IS REPORTEDLY WORKING GOOD NOW."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488801 ↗
• MalfunctionAug 27, 2020Material Deformation; Material Deformation

  IT WAS REPORTED "THIS PICC WAS PLACED ON 06/30, ON 07/30 THE RN WAS UNABLE TO FLUSH BOTH PORTS. RN TRIED CATHFLO LAST NIGHT WITHOUT SUCCESS. WHEN MANUAL PRESSURE APPLIED ABOVE SITE, CATHETER FLUSHED WELL AND HAD GOOD BLOOD RETURN. WHEN PRESSURE RELEASED, IT WOULD NOT FLUSH OR DRAW BACK BLOOD. RETRACTED 2 CM AND HAS GOOD BLOOD RETURN AND FLUSH." (B)(6) 20 CATHETER CONTINUED TO BE SLUGGISH, ALMOST TO THE POINT YOU COULD NOT FLUSH AT ALL. CHEST X-RAY OBTAINED THAT INCLUDED THE ARM, THAT REVEALED A KINK. PATIENT NEEDS THE LINE FOR LONG TERM ANTIBIOTICS SO THE LINE WAS REPLACED." ADDITIONAL INFO. RECEIVED 08/05/2020, "WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STATLOCK THAT WAS SUPPLIED WITH THE PICC KIT." "WAS THERE PATIENT HARM REPORTED? NO."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10460875 ↗
• MalfunctionAug 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THE PICC LINE WAS PLACED ON 07/04 BUT KINKED IN THE PATIENT'S ARM, PREVENTING THE NURSE FROM BEING ABLE TO FLUSH OR DRAW ON 07/15. THE NURSE PULLED THE PICC AND EXCHANGE IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370940 ↗
• MalfunctionAug 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THE PICC LINE WAS PLACED ON 07/04 BUT KINKED IN THE PATIENT'S ARM, PREVENTING THE NURSE FROM BEING ABLE TO FLUSH OR DRAW ON 07/15. THE NURSE PULLED THE PICC AND EXCHANGE IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370932 ↗
• MalfunctionJul 23, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON 6/30, NURSE REPORTED PICC TO BE POSITIONAL, BUT CATHETER DOES NOT HAVE A BLOOD RETURN. ON 7/1, PICC COMPETED OCCLUDED IN BOTH LUMENS. CHEST X-RAY SHOWED PICC TIP IN SVC AND ARM X-RAY SHOWED LOOP IN THE ARM, 10 CM ABOVE THE INSERTION SITE. PICC WAS REMOVED AND PIV INSERTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314643 ↗
• MalfunctionJul 23, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT 8 HOURS AFTER PICC WAS PLACED, THERE WAS NO BLOOD RETURN AND IT WAS EXTREMELY DIFFICULT TO FLUSH. WHEN NURSE PUSHED DOWN ON CATHETER AT THE SITE, IT WORKED FINE. THE PICC WAS THEN RETRACTED 1 CM AND IT WORKED GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314531 ↗