PowerPICC Provena S1274108D3Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00801741154942), received between Jul 10, 2020 and Aug 4, 2026 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Defective Component” (19 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Material Frayed

  It was reported that the customer experienced a PICC guidewire embolism today.Pt will be going for foreign body retrieval this afternoon. The wire was successfully retrieved. The patient had no other symptoms. No other intervention needed. The patient was discharged home.

  Patient problems: Foreign Body In Patient

  MAUDE report 50129449 ↗
• MalfunctionJun 24, 2026Fluid/Blood Leak

  IT WAS REPORTED BY MEDWATCH A 4FR POWERPICC "PURPLE" LUMEN CRACKED AND LEAKING AT THE Y-SITE. THIS WAS CAUGHT DURING THE PRIMING OF THE LINE AND PRIOR TO INSERTION INTO THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25608405 ↗
• MalfunctionAug 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, A MALFUNCTIONED PICC WITH PERSISTENT NO BLOOD RETURN ON RED LUMEN DESPITE ALTEPLASE. LINE WAS REMOVED AND FOUND A FRACTURE (SHORT OF AN INCH SLIT) ALONG THE CATHETER. NO APPARENT ADVERSE EVENT OR SERIOUS INJURY TO PATIENT OR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738569 ↗
• MalfunctionJul 17, 2025Activation Problem; Activation Problem

  IT WAS REPORTED, PICC NEEDLE RETRACTOR DID NOT ENGAGE WHEN PULLING THE SAFETY AFTER USE. NO PATIENT HARM/COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538541 ↗
• MalfunctionJul 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED VIA MEDSUN, GREEN NEEDLE USED TO ACCESS VEIN FOR PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] PLACEMENT AS PART OF PICC KIT. NEEDLE SAFETY DEVICE CAME OFF THE END OF NEEDLE. NO HARM OR NEEDLESTICK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473373 ↗
• MalfunctionJun 26, 2025Defective Component; Defective Component

  IT WAS REPORTED LEAKAGE FROM THE T-PORT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22336700 ↗
• MalfunctionJun 26, 2025Defective Component; Defective Component

  IT WAS REPORTED LEAKAGE FROM THE T-PORT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22336684 ↗
• MalfunctionJun 17, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THE SAFETY ON THE SECURELOC NEEDLE DID NOT ENGAGE, THEN CAME APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22240394 ↗
• MalfunctionJun 17, 2025Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER LEAKING AT T CONNECTOR WHEN FLUSHING (WHERE STYLET EXITS). SALINE SPRAY HCP BUT SHE WAS WEARING STERILE GOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22240366 ↗
• MalfunctionMay 14, 2025Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER A PIECE SEPARATED ON THE STYLET EXTENSION HUB. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019306 ↗
• MalfunctionMar 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THE ORDER SMELLS ROTTEN AND LOOKS LIKE IT HAS MILDEW ON IT. THEY DO NOT WANT TO USE THE PRODUCT AS IT MAY BE A SAFETY HAZARD FOR PATIENTS. IT WAS REPORTED THIS OCCURRED WITH FIVE CASES. THIS REPORT ADDRESSES ALL FIVE CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21602065 ↗
• InjuryOct 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT 3CG CONFIRMED PICC PLACEMENT ON (B)(6). ON (B)(6), PATIENT WAS HAVING ARRHYTHMIAS SO CXR WAS ORDERED. ON (B)(6) RADIOLOGIST STATES PICC WAS LONG AND HAD THEM PULL PICC BACK 9CMS. QUESTION IS WHY DID 3CG SHOW IT WAS GOOD PLACEMENT. AT FIRST THIS WAS JUST A SIMPLE EDUCATION QUESTION, NOW THE MANAGEMENT IS QUESTIONING WEATHER 3CG IS ACCURATE AND RELIABLE. ADDITIONAL INFO: PATIENT HAVING ARRHYTHMIA AFTER PICC PLACED WHICH WAS CONFIRMED BY 3CG. CXR COMPLETED AND PICC WAS MALPOSITIONED IN THE R ATRIUM. IT WAS DETERMINED ADDITIONAL 3CG EDUCATION SHOULD BE PROVIDED ALONG WITH LANDMARK MEASURING TECHNIQUES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia

  MAUDE report 20418841 ↗
• MalfunctionApr 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THE INTRODUCER GETS HUNG UP AT THE GRAY TIP. IT BUCKLES ON TOUGH SKIN AND CAUSE THE GRAY TO FOLD BACK AND BEND. WE HAVE TO OPEN AN MST KIT AND GET A NEW INTRODUCER. PEEL APART PIECE TEARS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117466 ↗
• MalfunctionAug 1, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE 4F DL PROVENA PICC KINKED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435120 ↗
• MalfunctionJul 20, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER, 4F DL PICC KINKED IN ARM COUPLE DAYS AFTER BEING INSERTED. ADDITIONAL INFO FROM CUSTOMER: ((B)(6) 2023): IT WAS REPORTED "SOFT TISSUE SACROCOCCYGEAL MASS. THIS WAS AN INPT. LEFT BASILIC VEIN WAS USED. PICC WAS REMOVED BY THE PROVIDER. DELAY IN IV MEDICATIONS. PICC HAD TO BE REPLACED AND THE LEFT ARM USED. DELAY IN CARE. PATIENT HAD TO ENDURE ANOTHER PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358113 ↗
• MalfunctionJul 12, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT "THEY HAVE BEEN HAVING ISSUES WITH LEAKING THROUGH THE STOPPER ON THE T PIECE THAT THE WIRE COMES OUT OF DURING PICC INSERTIONS FOR REHR0322." NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313067 ↗
• MalfunctionJul 12, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THEY HAVE BEEN HAVING MORE ISSUES WITH LEAKING THROUGH THE STOPPER ON THE T PIECE THAT THE WIRE COMES OUT OF DURING PICC INSERTIONS FOR REHQ1797. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023: THE EVENT DID NOT INVOLVE AN URGENT OR LIFE THREATENING MEDICAL SITUATION. THE LEAK WAS DISCOVERED DURING INSERTION PROCEDURE. THERE WAS NOTHING INFUSING AT THE TIME, IT WAS INTERMITTENTLY FLUSHED WITH NORMAL SALINE. THERE WAS NO INTERRUPTION OR DELAY IN THE ADMINISTRATION OF MEDICATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305472 ↗
• MalfunctionJun 7, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER, OCCURRENCES OF A LEAKING T-LOCK IN THE LAST WEEK. ADDITIONAL INFORMATION RECEIVED (B)(6)2023: "LEAKING OF FLUSH THROUGH STOPPER ON T CONNECTOR AT THE WIRE EXIT AREA. LEAKING WHEN FLUSHED, AND PULLING AIR INTO SYRINGE WHEN ASPIRATING TO CHECK BLOOD RETURN. NO PATIENT INJURY OR HARM, HOWEVER SIGNIFICANT RISK TO PATIENT (INFECTION, AIR EMBOLUS) AND INSERTER (BLOOD EXPOSURE). EVENT DID NOT INTERRUPT THE ADMINISTRATION OF ANY MEDICATIONS OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083532 ↗
• MalfunctionJun 7, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER, OCCURRENCES OF A LEAKING T-LOCK IN THE LAST WEEK. ADDITIONAL INFORMATION RECEIVED MAY 31, 2023: "LEAKING OF FLUSH THROUGH STOPPER ON T CONNECTOR AT THE WIRE EXIT AREA. LEAKING WHEN FLUSHED, AND PULLING AIR INTO SYRINGE WHEN ASPIRATING TO CHECK BLOOD RETURN. NO PATIENT INJURY OR HARM, HOWEVER SIGNIFICANT RISK TO PATIENT (INFECTION, AIR EMBOLUS) AND INSERTER (BLOOD EXPOSURE). EVENT DID NOT INTERRUPT THE ADMINISTRATION OF ANY MEDICATIONS OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083531 ↗
• MalfunctionJun 6, 2023Defective Component; Defective Component

  CUSTOMER REPORTED 2 OCCURRENCES OF A LEAKING T-LOCK IN THE LAST WEEK. NO OTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION ON 30 MAY 2023 LEAKING OF FLUSH THROUGH STOPPER ON T CONNECTOR AT THE WIRE EXIT AREA. LEAKING WHEN FLUSHED, AND PULLING AIR INTO SYRINGE WHEN ASPIRATING TO CHECK BLOOD RETURN. NO PATIENT INJURY OR HARM, HOWEVER SIGNIFICANT RISK TO PATIENT (INFECTION, AIR EMBOLUS) AND INSERTER (BLOOD EXPOSURE). THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071700 ↗
• MalfunctionJun 6, 2023Defective Component; Defective Component

  CUSTOMER REPORTED 2 OCCURRENCES OF A LEAKING T-LOCK IN THE LAST WEEK. NO OTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION ON 30 MAY 2023. LEAKING OF FLUSH THROUGH STOPPER ON T CONNECTOR AT THE WIRE EXIT AREA. LEAKING WHEN FLUSHED, AND PULLING AIR INTO SYRINGE WHEN ASPIRATING TO CHECK BLOOD RETURN. NO PATIENT INJURY OR HARM, HOWEVER SIGNIFICANT RISK TO PATIENT (INFECTION, AIR EMBOLUS) AND INSERTER (BLOOD EXPOSURE). THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071676 ↗
• MalfunctionJun 5, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER, "DURING PLACEMENT OF A PICC I NOTICED THAT WHEN I ASPIRATED TO CHECK FOR BLOOD RETURN THAT AIR WAS COMING INTO MY SYRINGE. I REMOVED THE SYRINGE FROM THE INJECTION PORT AND EXPELLED THE AIR THEN REATTACHED AND FLUSHED THE LINE. I NOTICED THAT THE SALINE WAS LEAKING OUT FROM AROUND THE WIRE COMING OUT OF THE RUBBER (UNSURE OF MATERIAL HERE) STOPPER. AFTER ENSURING THAT ALL MY CONNECTIONS WERE TIGHTLY SECURED, I ATTEMPTED TO ASPIRATE AGAIN AND PULLED AIR INTO MY SYRINGE. I REMOVED THE SYRINGE, EXPELLED THE AIR, REATTACHED AND ATTEMPTED TO FLUSH A SECOND TIME NOTING FLUID AGAIN LEAKING FROM THE SAME AREA WHEN FLUSHING. SYRINGE REMOVED AND PLACED ON THE OTHER LUMEN (PURPLE) AND WAS ABLE TO ASPIRATE BLOOD AND FLUSH WITHOUT ISSUE. I WAS ABLE TO LOOK CLOSER AND NOTICED THE LEAKING. PATIENT WAS SENT HOME WITH THE PICC THE NEXT DAY FOR 8 WEEKS OF IV ANTIBIOTICS. THE EVENT WAS NOT URGENT OR LIFE THREATENING. THERE WAS NO HARM TO THE PATIENT. PATIENT HAS NO RECORDED INFECTIOUS DISEASES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060941 ↗
• MalfunctionMay 31, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD A KINKED 4F DL PICC. CATHETER WAS KINKED BY THE CLAVICLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035386 ↗
• MalfunctionMay 25, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "DL PICC KINKING IN PATIENT". ADDITIONAL INFORMATION RECEIVED 05/08/2023: CUSTOMER REPORTED THIS WAS THE FIRST OF TWO KINKED CATHETERS WITH THE SAME LOT NUMBER. THIS PARTICULAR PATIENT WAS AN INPATIENT. VAS WAS CONSULTED X 2 TO ASSESS CATHETER BECAUSE RN WAS HAVING DIFFICULTY INFUSING. CHEST X-RAY RECOMMENDED. KINK NOTED IN ARM. PICC PULLED BACK AND WORKING. PT MEDS OFF SCHEDULE. REQUIRED MULTIPLE ASSESSMENTS, MANIPULATION AND TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004123 ↗
• MalfunctionMar 30, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT "THEY PLACED 7 PICCS YESTERDAY AND ALL OF THE DLS HAD SMALL TO SCANT AMOUNTS OF LEAKING THROUGH THE STOPPER AROUND THE WIRE WHEN FLUSHED." THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653062 ↗