PowerPICC Provena S1385108D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741155079), received between Apr 5, 2019 and May 12, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 16, 2026.

Recalls naming this device

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Material Deformation

  IT WAS REPORTED VIA MEDWATCH THAT POWERPICC PROVENA MICROEZ MICROINTRODUCER SHEATH 5.0 F (1.8 MM ID X 2.5 MM OD X 7 CM LENGTH) WITH VESSEL DILATOR (0.5 MM ID) WAS UNABLE TO THREAD THROUGH INSERTION SITE; TIP OF OUTER CANNULA OF THE SHEATH BUCKLED AND WAS UNABLE TO MAINTAIN THE SHAPE INTEGRITY DURING INSERTION ATTEMPT, REQUIRING STOPPING INSERTION OF SHEATH TO PREVENT INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153529 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE TRIPLE LUMEN PICC HAD A LEAK AT HUB. NO PATIENT HARM. ACCESS HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294690 ↗
• MalfunctionDec 29, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT E OPENED UP A TRIPLE LUMEN PICC AND WHEN PRIMING ONE OF THE LUMENS, WE WERE UNABLE TO FLUSH IT. IT WAS A HARD STOP WHEN TRYING TO PRIME THE LINE, THE LUMEN WAS NOT CLAMPED. WE, IN TURN, HAD TO OPEN A NEW KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919312 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS A HOLE IN THE EXTENSION LEGS. THERE WAS A HOLE IN THE EXTENSION LEGS OF A NEWLY PLACED PICC. THEY HAVE TO OVER-WIRE THE PICC TO REPLACE IT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206833 ↗
• MalfunctionJun 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE CATHETER WAS COILED AND HAD POOR BLOOD RETURN. XRAY READS: " LEFT-SIDE APPROACH PICC LINE CATHETER WITH DISTAL ENDS SLIGHTLY COILED BACK TO THE LEFT NEAR THE RIGHT HILAR REGION/SVC." THE CATHETER HAD BEEN INSERTED TO THE 0CM DEPTH MARK AND WAS PULLED BACK/REPOSITIONED 2CM ON (B)(6) 2025. AFTER THE PICC WAS PULLED BACK TO 2CM, BRISK BLOOD RETURN AND EASY FLUSH NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194230 ↗
• InjuryMay 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT'S ARM WAS VERY SWOLLEN, LINE LEAKING, DRESSING SATURATED AND PATIENT COMPLAINING OF PAIN. RN CALLED VAT WHO REMOVED THE LINE. LEAK OCCURRED ON (B)(6) 2025. TEAR ALONG LINE IS ABOUT 1CM LONG AT THE 4CM MARK. TPN EXTRAVASATION HAPPENED AS A RESULT, PHARMACY NOTIFIED, HYALURONIDASE SQ ORDERED. THE PATIENT HAS RECOVERED.

  Patient problems: Extravasation; Pain; Swelling/ Edema

  MAUDE report 22028184 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT PRODUCT MALFUNCTIONED WHEN THE HUB OF THE PICC BROKE FREE FROM THE LUMEN. PATIENT REQUIRED ADDITIONAL PROCEDURE TO PLACE NEW LINE AND THEN REQUIRED ADDITIONAL X-RAY IMAGING TO CONFIRM PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329216 ↗
• MalfunctionJan 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC PLACED ON 12/9 BY VASCULAR ACCESS TEAM AND USED ALL WEEK FOR PATIENT INFUSIONS. CT WAS COMPLETED USING MIDDLE LUMEN ON 12/14. ON 12/17, VASCULAR ACCESS WAS CALLED TO ASSESS THE PICC BECAUSE THERE WAS NO/LITTLE BLOOD RETURN. LEAKING WAS DISCOVERED SO THE LINE WAS REMOVED, AND THEN THE HOLE IN THE LINE WAS DISCOVERED AT THE 5 CM MARK. END OF THE LINE WAS CUT DURING REMOVAL BUT PIR IS ABOUT ISSUE AT 5 CM MARK. PICC PLACED MID-THIGH ON HIGH BMI PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162542 ↗
• MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "THERE IS A LEAKING AT 3CM MARK OF CATHETER WHITE LUMEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112769 ↗
• MalfunctionSep 11, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE GREEN SAFETY IS SLIDING OFF OF THE NEEDLE AND EXPOSING THE NEEDLE TIP. NO HARM TO PATIENT OR HCP, NO NEEDLE STICK INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192573 ↗
• MalfunctionMay 22, 2024Activation Problem; Activation Problem

  IT WAS REPORTED NEW NEEDLE IN PICC KIT ENTIRELY FELL APART DURING USAGE WHILE CLINICIAN TRIED TO SAFETY THE NEEDLE. NEEDLE FELL TO PIECES IN USE. HCP WAS ABLE TO GRAB IT BEFORE LOSING THE NEEDLE IN THE PATIENT BUT CAUSED HCO TO RE-STICK AND LOSE ACCESS. THIS DID NOT CAUSE ANY LIFE THREATENING SITUATIONS OR INTERRUPT MEDICATIONS. NO ADVERSE EFFECTS REPORTED. HCP WAS ABLE TO PLACE PICC WITHOUT UNTOWARD EFFECT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376738 ↗
• MalfunctionJun 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "CUSTOMER SHARED THAT THEY IDENTIFIED A HOLE IN THE PICC LINE A DAY AFTER PLACING THE LINE. MENTIONED THAT THE LINE DID NOT HAVE A HOLE AFTER PLACING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569159 ↗
• MalfunctionFeb 16, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED "WE HAD A PATIENT WITH A TRIPLE LUMEN PICC AND AFTER A COUPLE DAYS, THE WHITE END OF THE ONE LUMEN CAME OFF." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546150 ↗
• MalfunctionNov 10, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED "NURSE FEELS AS THOUGH THERE IS A SHORT IN THE 3CG WIRE. WHILE INSERTING THE WIRE WOULD INTERMITTENTLY PICK UP AND SHE REALIZED THAT IF SHE HELD THE 3CG WIRE A CERTAIN WAY AND KEPT IT OFF FROM RESTING ON THE BED THEN IT WOULD WORK." (B)(6) 2021: THE RETURNED SAMPLE EXHIBITED A KINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786884 ↗
• MalfunctionSep 17, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "WIRE BROKE. CLINICIAN NEVER MET ANY RESISTANCE. COVID PATIENT. DID NOT SAVE WIRE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490244 ↗
• MalfunctionAug 5, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "THE WIRE FROM A PROVENA PICC FRAYED." ADDITIONAL INFO. RECEIVED 07/15/2021 "INITIAL WIRE WENT IN WITHOUT DIFFICULTY. PEEL AWAY SHEATH INSERTED AND PICC MEASURED AND CUT TO FIT. SHERLOCK WIRE INSIDE PICC AND ATTEMPTED TO ADVANCE PICC. DIFFICULTY CROSSING SHOULDER. PATIENT REPORTED FEELING LINE IN ARMPIT. PULLED BACK AND REATTEMPTED. STILL UNSUCCESSFUL. WITH THIRD REPOSITIONING, ABLE TO ADVANCE BOTH PICC PASSED SHOULDER AND IT SHOWED UP ON SHERLOCK WITH 3CG. ATTEMPTED TO REMOVE SHERLOCK WITH AND IT WAS WITH DIFFICULTY. RESISTANCE MET. ENTIRE PICC AND WIRE REMOVED TOGETHER. UPON INSPECTION OF PICC AFTER REMOVING FROM BODY CATHETER WAS BENT AND DEFORMED. THIS TIME WAS ABLE TO REMOVE SHERLOCK WIRE FROM CATHETER BUT TIP MISSING. FLUSHED CATHETER AND TIP PUSHED OUT OF CATHETER ONTO STERILE FIELD. NO HARM TO PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280552 ↗
• MalfunctionJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE EXTENSION LEG HUB BECAME DETACHED FROM PICC, PICC HAD TO BE REPLACED BECAUSE THE LUMEN COULD NOT BE CLOSED. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938144 ↗
• MalfunctionMay 7, 2021Material Frayed; Material Frayed

  IT WAS REPORTED 5FR TL SYTLET WAS FRACTURED 3CM PROXIMAL TO THE MAGNETS. THE NURSE NOTICE THE STYLET WAS FRACTURED AFTER PLACEMENT WHEN SHE RETRACTED THE STYLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791103 ↗
• MalfunctionFeb 19, 2021Break

  IT WAS REPORTED WHILE PLACING A PICC WITH A CUSTOM KIT THE CUSTOMER TRIED TO BEND THE WIRE AND THE WIRE SNAPPED. CLINICAL SPECIALIST PRESENT DURING EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11349372 ↗
• MalfunctionNov 20, 2020Break; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED AFTER PLACING PICC AND REMOVING THE 3CG STYLET WIRE, CLINICIAN SAW THE WIRE WAS KINKED NEAR THE DISTAL END. CLINICIAN CLAIMED THERE WAS RESISTANCE THREADING THE PICC AND HAD TO MOVE THE PICC BACK AND FORTH TO EVENTUALLY GET THE CATHETER IN THE OPTIMAL PLACE. ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THE GUIDEWIRE BROKE IN TWO WHILE TRYING TO INSERT INTO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10876411 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED CUSTOMER ASKING ABOUT A PRODUCT LOT # THAT THEY THINK THEY HAD A CLABSI WITH IN (B)(6). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10175602 ↗
• MalfunctionApr 5, 2019Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THE PICC HAD A HOLE AT THE 1 CM MARK. THE PICC WAS REMOVED. ADDITIONAL INFORMATION RECEIVED FROM TM STATED, "NURSE FLUSHED THE LINE AND SAW THE LEAK." A NEW PICC WAS PLACED AFTER THE REMOVAL OF THE LEAKING PICC LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8488161 ↗