PowerPICC Provena S1274108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 00801741130366), received between Jun 16, 2017 and Apr 2, 2025 — classified as 7 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (19 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 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER GREEN SAFETY NEEDLE ON A 4FR DUAL LUMEN PICC KIT CAME APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21754124 ↗
• MalfunctionFeb 21, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT TWO SAFETY NEEDLES FELL APART WHEN DEPLOYING THE GREEN SAFETY MECHANISM OVER THE WIRE. NO PATIENT HARM OCCURRED. NO FURTHER INFORMATION WAS RECEIVED. THIS REPORT ADDRESSES BOTH NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432947 ↗
• MalfunctionFeb 6, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE SAFETY MECHANISM DOES NOT ACTIVATE AND DETACHES COMPLETELY. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329224 ↗
• MalfunctionJul 15, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER "AFTER A COUPLE OF PASSES WITH THE COPPER TIP OF THE WIRE, IT WAS PULLED OUT OF THE PATIENT AND THE TIP COMPLETELY SHEARED FROM THE REST OF THE WIRE. IT WAS A DIFFICULT PICC TO GET TO DROP IN THE SVC AND HAD TO PASS A COUPLE OF TIMES TO GET IT TO DROP. THERE WAS SOME RESISTANCE PULLING THE WIRE OUT, WHICH IS WHEN IT SHEARED. THE SHEARED WIRE DID NOT GET STUCK IN THE PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744791 ↗
• MalfunctionAug 22, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED 4 DUAL PICC THAT HAD A WIRE CRIMP IN TWO PLACES. IT WAS A HARD PICC TO PLACE AND THEY COMPETED WITH IJ AND PACER WIRES. PLACER HAD A LOT OF TENSION TRYING TO THREAD AND PULL BACK THE WIRE. SHE HAD TO OPEN UP A NEW KIT TO BE SUCCESSFUL DROPPING THE PICC LINE. ADDITIONAL INFORMATION RECEIVED 16 AUGUST 2023: EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596438 ↗
• MalfunctionAug 22, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED 4 DUAL PICC THAT HAD A WIRE CRIMP IN TWO PLACES. IT WAS A HARD PICC TO PLACE AND THEY COMPETED WITH IJ AND PACER WIRES. PLACER HAD A LOT OF TENSION TRYING TO THREAD AND PULL BACK THE WIRE. SHE HAD TO OPEN UP A NEW KIT TO BE SUCCESSFUL DROPPING THE PICC LINE. ADDITIONAL INFORMATION RECEIVED 16 AUGUST 2023: EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596435 ↗
• MalfunctionAug 22, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED 4 DUAL PICC THAT HAD A WIRE CRIMP IN TWO PLACES. IT WAS A HARD PICC TO PLACE AND THEY COMPETED WITH IJ AND PACER WIRES. PLACER HAD A LOT OF TENSION TRYING TO THREAD AND PULL BACK THE WIRE. SHE HAD TO OPEN UP A NEW KIT TO BE SUCCESSFUL DROPPING THE PICC LINE. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023: EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596432 ↗
• MalfunctionAug 22, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED 4 DUAL PICC THAT HAD A WIRE CRIMP IN TWO PLACES. IT WAS A HARD PICC TO PLACE AND THEY COMPETED WITH IJ AND PACER WIRES. PLACER HAD A LOT OF TENSION TRYING TO THREAD AND PULL BACK THE WIRE. SHE HAD TO OPEN UP A NEW KIT TO BE SUCCESSFUL DROPPING THE PICC LINE. ADDITIONAL INFORMATION RECEIVED 16 AUGUST 2023: EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596424 ↗
• MalfunctionJul 12, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT HE CLEARED PLASTIC HUB WHICH THE INSERTION WIRE GOES THROUGH IS BOTH LEAKING AIR AND FLUID. WHEN HE DREW BACK TO CHECK FOR BLOOD FLOW, AIR GETS PULLED INTO SYRINGE. WHEN HE FLUSHED TBE SALINE SQUIRTS OUT AROUND WIRE. IT IS MORE THAN JUST A BUBBLE OR TWO OF AIR. I OBSERVED BETWEEN 2-3 CC OF AIR DRAWN UP INTO FLUSH SYRINGE. IT WAS NOT DUE TO A LOOSE HUB. UNABLE TO QUANTIFY AMOUNT OF SALINE THAT LEAKS OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17312992 ↗
• MalfunctionJun 29, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER, CLINICIAN GOT INTO THE VEIN AND PUT THE INTRODUCER IN BUT COULD NOT THREAD THE PICC. SHE WAS ABLE TO REMOVE THE PICC WITHOUT ANY PROBLEM BUT AFTER REMOVING THE PICC SHE CHECKED THE WIRE AND NOTED IT WAS BENT IT 2 PLACES AND WAS DANGLING FROM THOSE 2 PLACES. PIECES DID NOT BREAK OFF. WE DID NOT USE ANY GREAT FORCE TO PULL OR PUSH IN THE PICC AS WE NEVER FORCEFULLY WITH PICCS OR WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17234785 ↗
• MalfunctionJun 22, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT PICC WOULDN'T COME OUT OF PATIENT DURING PICC PROCEDURE. THE RN TOOK INTRODUCER OUT AND PULLED WHOLE THING AND THE WIRE WAS BROKEN AND OUT OF SKIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187363 ↗
• MalfunctionApr 17, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "LEAKING AT T PORT CONNECTOR UPON FLUSHING." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16753319 ↗
• MalfunctionAug 31, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED " A PATIENT HAD A 4F POWERPICC LINE AND IT BEGAN TO LEAK AND THE NURSE HAD THE PICC REMOVED FROM THE PATIENT. IT APPEARS THAT THE TUBING BELOW THE HUB MAY HAVE BEEN CRACKED WHICH IS WHAT CAUSED THE LEAKING. THEY ARE UNSURE WHAT CAUSED THE CRACK AND IF IT WAS THERE WHEN PLACED OF FORMED WHILE IN USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327644 ↗
• InjuryMay 20, 2022Material Frayed; Material Frayed

  IT WAS REPORTED BY BD REP "THE INSERTION WAS ULTIMATELY SUCCESSFUL, SO THE NURSE REQUESTED AN X-RAY TO CONFIRM TIP LOCATION. THE NURSE ALSO NOTED THAT THE GUIDEWIRE WAS BENT NEAR THE TIP AFTER THE INSERTION. THE X-RAY REVEALED A ~ 1.9-2CM PIECE OF THE GUIDEWIRE THAT HAD FRACTURED OFF AND WAS FOUND IN THE AXILLA REGION." ADD INFO RECEIVED: DID THE PATIENT REQUIRE SURGERY TO REMOVE THE BROKEN PIECE? ENDOVASCULAR RETRIEVAL WAS ATTEMPTED BUT UNSUCCESSFUL. PROVIDERS OPTED TO NOT PURSUE SURGICAL REMOVAL DUE TO RISK OF SURGERY COMPARED TO LOWER RISK OF JUST LEAVING RETAINED PIECE BEHIND WERE ALL THE MISSING/BROKEN PIECES RETRIEVED AND ACCOUNTED FOR? NO, UNABLE TO RETRIEVE BROKEN PIECE WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. BROKEN PIECE HAD ALREADY MIGRATED TO LEFT VENTRICLE. LAST IMAGING STUDIES SHOW BROKEN WIRE FRAGMENT (APPROX. 1.9 CM) LODGED IN THE TRICUSPID CORDAE. PATIENT DOES NOT APPEAR TO BE SYMPTOMATIC AS A RESULT OF THE BROKEN WIRE FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14462425 ↗
• MalfunctionMar 19, 2022Material Frayed; Material Frayed

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "MEASURED THE PICC LENGTH BEFORE PLACING. MEASURED AT 55CM- SO NO CUTTING NECESSARY. TRIED TO THREAD THE CATHETER-MET RESISTANCE AT 10 CM OUT AND COULD NOT FLUSH AT THAT POINT. PULLED CATHETER OUT, AT THE SHEATH CATHETER TWISTED SOME. TRIED TO PLACE AGAIN-SAME THING THE CATHETER MET RESISTANCE AT 10 CM OUT AND COULD NOT FLUSH. CATHETER REMOVED TO CUT TO MID LINE LENGTH TO HOLD ACCESS. I PULLED THE WIRE BACK TO TRIM CATHETER. THEN NOTICED WIRE TIP STILL IN CATHETER. PULLED SHORT PIECE OF WIRE OUT OF CATHETER. WE HAD X-RAY OF ARM/CHEST DONE-NO FRAGMENTS OF WIRE SEEN." ADDITIONAL INFORMATION RECEIVED 02/24/2022: HOW WAS THE BREAK AND/OR RETAINED SEGMENT DISCOVERED? PIECE OF WIRE STILL IN PICC AFTER REMOVAL. X-RAY DONE TO CHECK FOR RETAINED PARTS. DID THE PATIENT REQUIRE SURGERY TO REMOVE THE BROKEN PIECE? NO. WERE ALL THE MISSING/BROKEN PIECES RETRIEVED AND ACCOUNTED FOR? YES. WHAT TYPE OF IMAGING WAS USED TO VERIFY BROKEN PIECE IN PATIENT? X-RAY DONE- NO PIECE OF WIRE SEEN. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? NO. AT WHAT POINT DURING DEVICE USE (I.E. INSERTION, INFUSION, REMOVAL) DID THE BREAK OCCUR? INSERTION. ANY LONG-TERM PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825350 ↗
• MalfunctionAug 27, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "PICC LINE WAS ATTEMPTED FOR INSERTION INTO RIGHT ARM. UPON ADVANCING PICC CATHETER INTO VESSEL ON THE FIRST ATTEMPT, DIFFICULTY NOTED PASSING OVER SHOULDER. PICC LINE REMOVED AND INTERNAL WIRE NOTED TO BE CURVED APPROXIMATELY 3 INCHES BEFORE THE TIP. INTERNAL WIRE INSERTED BACK INTO PICC LINE AND SECOND INSERTION ATTEMPTED. AGAIN RESISTANCE NOTED WHILE TRYING TO PASS THE SHOULDER. UPON ATTEMPTING TO REMOVE CATHETER SOME RESISTANCE NOTED, PROBABLE VESSEL SPASM. PICC WAS ABLE TO BE SLOWLY REMOVED INTACT. UPON INSPECTING INTERNAL WIRE, IT WAS NOTED TO BE BENT IN TWO PLACES. PICC LINE ATTEMPT ABORTED ON THIS ARM. UPON PLACING FAULTY WIRE IN BAG, PART OF WIRE ACTUALLY BROKE OFF. NO INJURY WHATSOEVER TO PATIENT." THIS REPORT ADDRESSES THE FIRST ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380201 ↗
• MalfunctionAug 27, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "PICC LINE WAS ATTEMPTED FOR INSERTION INTO RIGHT ARM. UPON ADVANCING PICC CATHETER INTO VESSEL ON THE FIRST ATTEMPT, DIFFICULTY NOTED PASSING OVER SHOULDER. PICC LINE REMOVED AND INTERNAL WIRE NOTED TO BE CURVED APPROXIMATELY 3 INCHES BEFORE THE TIP. INTERNAL WIRE INSERTED BACK INTO PICC LINE AND SECOND INSERTION ATTEMPTED. AGAIN RESISTANCE NOTED WHILE TRYING TO PASS THE SHOULDER. UPON ATTEMPTING TO REMOVE CATHETER SOME RESISTANCE NOTED, PROBABLE VESSEL SPASM. PICC WAS ABLE TO BE SLOWLY REMOVED INTACT. UPON INSPECTING INTERNAL WIRE, IT WAS NOTED TO BE BENT IN TWO PLACES. PICC LINE ATTEMPT ABORTED ON THIS ARM. UPON PLACING FAULTY WIRE IN BAG, PART OF WIRE ACTUALLY BROKE OFF. NO INJURY WHATSOEVER TO PATIENT. " THIS REPORT ADDRESSES THE SECOND ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380199 ↗
• MalfunctionAug 20, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "STYLET WIRE BROKE OFF DURING PICC INSERTION." ADDITIONAL INFORMATION RECEIVED 08/03/2021: LEFT INSERTION WHICH MET SLIGHT RESISTANCE (REPOSITIONED PATIENT) EASY INSERT TO DISTAL SVC. PICC MEASUREMENT OFF, PICC PULLED TO RETRIM, NOTICED COPPER TIP PROTRUDING FROM END OF PICC AT WHICH TIME NOTICED THAT TIP WAS BROKEN OFF. WIRE WAS NOT TAPED TO HOLD POSITION AND WAS NOTED TO HAVE MOVED FROM ORIGINAL POSITION. DID THE WIRE GET STUCK IN THE PATIENT: NO. PLACEMENT INFO: LEFT BASILIC 4 FR. 2 LUMEN. WAS THERE PATIENT HARM REPORTED?: NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351067 ↗
• InjuryJul 16, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "PICC ECG WIRE TIP BROKE OFF DURING INSERTION AND IS INSIDE PATIENT." ADDITIONAL INFORMATION RCVD 06/28/2021 "NO IT HAS NOT BEEN REMOVED, AND HAVE NOT BEEN NOTIFIED OF ANY PENDING PROCEDURES."

  Patient problems: Foreign Body In Patient

  MAUDE report 12182116 ↗
• MalfunctionJun 3, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED A WIRE BENT. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11934341 ↗
• MalfunctionApr 23, 2021Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE INTRODUCER SHEARED WHEN ATTEMPTING TO ACCESS THE SKIN. A NEW INTRODUCER WAS USED WITH NO ISSUES. ADDITIONAL INFO: WAS THERE ANY PATIENT HARM REPORTED? YES MAY HAVE LED TO INCREASE BLEEDING AT THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720412 ↗
• MalfunctionApr 23, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED WE'VE HAD TWO INSTANCES WHERE THE INTRODUCERS WERE SHEARING WHEN ATTEMPTING TO ACCESS THE SKIN. A NEW INTRODUCER WAS USED AND WORKED FINE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713597 ↗
• MalfunctionApr 23, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED WE'VE HAD TWO INSTANCES WHERE THE INTRODUCERS WERE SHEARING WHEN ATTEMPTING TO ACCESS THE SKIN. A NEW INTRODUCER WAS USED AND WORKED FINE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713590 ↗
• MalfunctionApr 16, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THE PICC WIRE WAS COMPLETELY BROKEN OFF. THE LINE WAS REMOVED TO ATTEMPT PLACEMENT ON THE OPPOSITE SIDE. IT WAS A DIFFICULT THREAD BUT LINE WAS NOT FORCED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682734 ↗
• MalfunctionMar 26, 2021Material Frayed; Material Frayed

  IT WAS REPORTED PICC WIRE FELL APART. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11578185 ↗