PowerPICC Provena S1274108D5Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00801741155154), received between May 31, 2019 and Mar 14, 2025 — classified as 5 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (29 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Activation Problem; Activation Problem

  IT WAS REPORTED CUSTOMER EXPERIENCED AN ISSUE WITH THE SAFETY DEVICE ON THE INSERTION NEEDLE. ADDITIONAL INFORMATION RECEIVED 2/26/2025: IT WAS REPORTED THE SAFETY DEVICE ON THE INSERTION NEEDLE FELL OFF. COURSE OF TREATMENT WAS NOT ALTERED, NO HARM TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607508 ↗
• MalfunctionJan 4, 2025Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED 5 PICCS KINKED. PICCS WERE READJUSTED, EXCHANGED, REMOVED, AND/OR REPLACED. PICC DWELL TIME RANGED FROM 0 TO 18 DAYS. 3 PICCS REQUIRED THE USE OF TPA. THIS REPORT ADDRESSES ALL FIVE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075661 ↗
• MalfunctionAug 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED INTRODUCER WILL NOT GO INTO THE PATIENT WITHOUT MASSIVE FORCE. ADDITIONAL INFORMATION RECEIVED 03/13/2024: THERE WAS NO ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL. THERE WAS NO DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT. THERE WERE NO CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT. ANOTHER KIT WAS OPENED TO COMPLETE TREATMENT FOR THE PATIENT. 07/17/2024 - THE DEVICE RETURNED FOR EVALUATION EXHIBITED BUCKLING AND REGIONS THAT WERE INDENTED ON THE DISTAL END OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940348 ↗
• MalfunctionJul 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT HAVE PLACED A TOTAL OF 4 MID-THIGH CATHETERS WITH THE FOLLOWING REFERENCE: S1274108D5 AND LOT NUMBERS: REJQ0717. 3 OF THESE LINES WE HAVE DOCUMENTED KINKS THAT HAVE RESULTED IN LINE REMOVAL AND THE LAST LINE I¿VE HAD TO CATHFLO ABOUT 3 TIMES ALREADY SINCE IT WAS PLACED. ALL CATHETERS ARE SIGNIFICANTLY KINKED AT 6/7CM MARK AND 35 CM MARK. NO ISSUES UPON INSERTION. VERIFIED BY X-RAY UPON PLACEMENT. ALL LINES PLACED MID-THIGH AT BEDSIDE. NO SERIOUS INJURY, BUT PATIENTS RECEIVED UNNECESSARY ALTEPLASE ADMINISTRATION, DELAY IN TREATMENT DUE TO LINE NOT WORKING, AND ONE PATIENT REQUIRED THE INSERTION OF A TUNNELED CATHETER. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651337 ↗
• MalfunctionJul 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT HAVE PLACED A TOTAL OF 4 MID-THIGH CATHETERS WITH THE FOLLOWING REFERENCE S1274108D5 AND LOT NUMBERS REJQ0717. 3 OF THESE LINES WE HAVE DOCUMENTED KINKS THAT HAVE RESULTED IN LINE REMOVAL AND THE LAST LINE I¿VE HAD TO CATHFLO ABOUT 3 TIMES ALREADY SINCE IT WAS PLACED. ALL CATHETERS ARE SIGNIFICANTLY KINKED AT 6/7CM MARK AND 35 CM MARK. NO ISSUES UPON INSERTION. VERIFIED BY X-RAY UPON PLACEMENT. ALL LINES PLACED MID-THIGH AT BEDSIDE. NO SERIOUS INJURY, BUT PATIENTS RECEIVED UNNECESSARY ALTEPLASE ADMINISTRATION, DELAY IN TREATMENT DUE TO LINE NOT WORKING, AND ONE PATIENT REQUIRED THE INSERTION OF A TUNNELED CATHETER. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651240 ↗
• MalfunctionJul 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT HAVE PLACED A TOTAL OF 4 MID-THIGH CATHETERS WITH THE FOLLOWING REFERENCE S1274108D5 AND LOT NUMBERS REJQ0717. 3 OF THESE LINES WE HAVE DOCUMENTED KINKS THAT HAVE RESULTED IN LINE REMOVAL AND THE LAST LINE I¿VE HAD TO CATHFLO ABOUT 3 TIMES ALREADY SINCE IT WAS PLACED. ALL CATHETERS ARE SIGNIFICANTLY KINKED AT 6/7CM MARK AND 35 CM MARK. NO ISSUES UPON INSERTION. VERIFIED BY X-RAY UPON PLACEMENT. ALL LINES PLACED MID-THIGH AT BEDSIDE. NO SERIOUS INJURY, BUT PATIENTS RECEIVED UNNECESSARY ALTEPLASE ADMINISTRATION, DELAY IN TREATMENT DUE TO LINE NOT WORKING, AND ONE PATIENT REQUIRED THE INSERTION OF A TUNNELED CATHETER. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651084 ↗
• MalfunctionJul 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT HAVE PLACED A TOTAL OF 4 MID-THIGH CATHETERS WITH THE FOLLOWING REFERENCE S1274108D5 AND LOT NUMBERS REJQ0717. 3 OF THESE LINES WE HAVE DOCUMENTED KINKS THAT HAVE RESULTED IN LINE REMOVAL AND THE LAST LINE I¿VE HAD TO CATHFLO ABOUT 3 TIMES ALREADY SINCE IT WAS PLACED. ALL CATHETERS ARE SIGNIFICANTLY KINKED AT 6/7CM MARK AND 35 CM MARK. NO ISSUES UPON INSERTION. VERIFIED BY X-RAY UPON PLACEMENT. ALL LINES PLACED MID-THIGH AT BEDSIDE. NO SERIOUS INJURY, BUT PATIENTS RECEIVED UNNECESSARY ALTEPLASE ADMINISTRATION, DELAY IN TREATMENT DUE TO LINE NOT WORKING, AND ONE PATIENT REQUIRED THE INSERTION OF A TUNNELED CATHETER. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651076 ↗
• MalfunctionJun 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC HAS SMALL HOLE IN IT. ADDITIONAL INFORMATION RECEIVED 06/11/2024: IT WAS REPORTED THAT ON (B)(6) 2024 VASCULAR ACCESS NURSE CALLED TO BEDSIDE DUE TO ASSESS "LEAKING" AND POSITIONAL PICC LINE (INSERTED ON (B)(6) 2024). DRESSING CHANGED WITH NO NOTED KINK EXTERNAL. CXR AND HUMEROUS XRAY ORDERED WITH KINKING NOTED IN ARM. PICC WITHDRAWN 4CM AND FLUSHED. PICC NOTED TO BE LEAKING AROUND 5CM. UPON ASSESSMENT, CATHETER FRACTURE NOTED AND PICC DISCONTINUED WITHOUT ISSUES PER ORDER. NO NOTED INFILTRATION TO SURROUNDING TISSUE AND PATIENT DENIED PAIN OR DISCOMFORT AT SITE OR IN R UPPER ARM PROXIMAL TO INSERTION SITE. A NEW PICC WAS ATTEMPTED SO THAT PATIENT COULD CONTINUE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19641083 ↗
• MalfunctionFeb 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT INTRODUCER NOT SLIDING INTO PATIENT AS EXPECTED, DIFFICULTY WITH INTRODUCER. ADDITIONAL INFORMATION RECEIVED 1/30/2024: IT WAS REPORTED BY THE CUSTOMER THE SHEATH ON THE INTRODUCER IS CATCHING ON THE SKIN UPON INSERTION AND PEELING BACK. USER HAD TO OPEN ANOTHER KIT TO ACCESS PATIENT. NO ADVERSE EVENT OR HARM REPORTED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712780 ↗
• MalfunctionFeb 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT INTRODUCER NOT SLIDING INTO PATIENT AS EXPECTED, DIFFICULTY WITH INTRODUCER. ADDITIONAL INFORMATION RECEIVED 1/30/2024: IT WAS REPORTED BY THE CUSTOMER THE SHEATH ON THE INTRODUCER IS CATCHING ON THE SKIN UPON INSERTION AND PEELING BACK. USER HAD TO OPEN ANOTHER KIT TO ACCESS PATIENT. NO ADVERSE EVENT OR HARM REPORTED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712779 ↗
• MalfunctionSep 12, 2023

  HUB ON SENSOR ATTACHMENT WOULD NOT FLUSH. PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) FLUSHED PERFECTLY, NO DAMAGE TO PICC OR SENSOR, THIS WAS CHECKED PRIOR TO ACCESSING VESSEL. DOUBLE LUMEN PICC, SO INSERTER CHECKED BLOOD RETURN USING SECOND LUMEN AFTER PICC PLACED, BLOOD RETURN ASSESSED ONCE SENSOR REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729215 ↗
• MalfunctionAug 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "NURSE WAS PLACING A PICC YESTERDAY AND THEN WHEN SHE WAS FLUSHING THE PORTS AND GOT TO THE PURPLE ONE, FOUND IT WAS LEAKING AT THE HUB. SHE DID AN OVER THE WIRE EXCHANGE." RESPONSE RECEIVED ON 11-AUG-2023. "EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION OR CAUSE CLINICALLY SIGNIFICANT DELAY. SINCE MY NURSE WAS ABLE TO DO AN OVER-THE-WIRE EXCHANGE, THERE WERE NO COMPLICATIONS TO THE PATIENT OR SIGNIFICANT DELAY OF CARE. THE CATHETER HAD NOT YET BEEN SECURED AT THE TIME THE DEFECT WAS NOTICED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612329 ↗
• MalfunctionAug 23, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE INTRODUCER WOULD NOT ADVANCE. WHEN IT WAS REMOVED AND INSPECTED, A NOTCH WAS NOTED WHERE THE INNER AND OUTER INTRODUCER SEGMENTS JOIN. ADDITIONAL INFO FROM CUSTOMER: ((B)(6) 2023) ITEM WAS NOT SAVED. DIRECTLY AFFECTED PATIENT - HAD TO FIND ALTERNATE INTRODUCER. ROUTINE INSERTION. ADDITIONAL INFO FROM CUSTOMER: ((B)(6) 2023) THE PATIENT WAS IN INTENSIVE CARE INTUBATED, SEDATED, INFUSING VASOPRESSORS AND IN NEED OF CENTRAL LINE ACCESS. THE DEFECT WAS DISCOVERED UPON TRYING TO INSERT INTRODUCER AND MEETING SIGNIFICANT RESISTANCE, ALMOST RECOILING. INTRODUCER ADVANCED THROUGH SKIN, BUT UNABLE TO ACCESS VEIN. NO HARM CAME TO PATIENT, THIS DID NOT DELAY CARE, NO NEGATIVE IMPACT NOTED. A NEW INTRODUCER KIT WAS UTILIZED AND FURTHER PICC PLACEMENT WAS SUCCESSFUL. IT DID NOT INVOLVE LIFE THREATENING MEDICAL SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603355 ↗
• MalfunctionAug 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE INTRODUCER WOULD NOT ADVANCE. WHEN IT WAS REMOVED AND INSPECTED, A NOTCH WAS NOTED WHERE THE INNER AND OUTER INTRODUCER SEGMENTS JOIN. THE CUSTOMER STATES THIS IS THE SECOND TIME THIS HAS HAPPENED. ADDITIONAL INFORMATION RECEIVED: IT WAS STATED THE EVENTS DIRECTLY AFFECTED PATIENTS, HAD TO FIND ALTERNATE INTRODUCER. THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION, ROUTINE INSERTION. THIS REPORT ADDRESSES THE SECOND EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491700 ↗
• MalfunctionAug 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE INTRODUCER WOULD NOT ADVANCE. WHEN IT WAS REMOVED AND INSPECTED, A NOTCH WAS NOTED WHERE THE INNER AND OUTER INTRODUCER SEGMENTS JOIN. ADDITIONAL INFORMATION RECEIVED: IT WAS STATED THE EVENT DIRECTLY AFFECTED PATIENT, HAD TO FIND ALTERNATE INTRODUCER. THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION, ROUTINE INSERTION. ADDITIONAL INFORMATION RECEIVED 17 AUGUST 2023: THE PATIENT WAS IN INTENSIVE CARE INTUBATED, SEDATED, INFUSING VASOPRESSORS AND IN NEED OF CENTRAL LINE ACCESS. THE DEFECT WAS DISCOVERED UPON TRYING TO INSERT INTRODUCER AND MEETING SIGNIFICANT RESISTANCE, ALMOST RECOILING. INTRODUCER ADVANCED THROUGH SKIN, BUT UNABLE TO ACCESS VEIN. NO HARM CAME TO PATIENT, THIS DID NOT DELAY CARE, NO NEGATIVE IMPACT NOTED. A NEW INTRODUCER KIT WAS UTILIZED AND FURTHER PICC PLACEMENT WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491540 ↗
• MalfunctionAug 2, 2023

  SENSOR BENT AND BROKE.

  Patient problems: Insufficient Information

  MAUDE report 17441702 ↗
• MalfunctionJul 31, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT 4FR PROVENA PICC CLAMP ON PURPLE LUMEN CRACKED CAUSING CLAMP NOT TO FASTEN. ADD INFO RECEIVED (B)(6) 2023. EVENT DID NOT INVOLVE URGENT/LIFE THREATENING EVENT THE CRACK WAS DISCOVERED WHEN THE NURSE TRIED TO CLAMP THE CLAMP MULTIPLE TIMES AND IT KEPT COMING OPEN. WHEN SHE LOOKED AT IT, SHE NOTICED THE CRACK. THE EVENT CAUSED THE PATIENT TO HAVE AN OVER THE WIRE EXCHANGE OF THE PICC. NO DELAY IN CARE. NO SIGNS, SYMPTOMS OR COMPLICATIONS TO PATIENT. STAT LOCK SECUREMENT WAS USED. NO LEAKAGE OF MEDICATION/FLUID BECAUSE THE CRACK IN THE CLAMP WAS NOTICED IMMEDIATELY AFTER LINE WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424860 ↗
• MalfunctionJun 6, 2023Defective Component; Defective Component

  IT WAS REPORTED, 3 OF CLINICIAN'S PICCS TODAY HAVE HAD THE SAME ISSUE. AGAIN ITS LEAKING AROUND THE WIRE THAT COMES OUT OF THE STOPPER. I ALSO HAD THIS HAPPEN WHEN I WAS WITH CLINICIAN THE OTHER DAY. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17071401 ↗
• MalfunctionJun 6, 2023Defective Component; Defective Component

  IT WAS REPORTED, 3 OF CLINICIAN'S PICCS TODAY HAVE HAD THE SAME ISSUE. AGAIN ITS LEAKING AROUND THE WIRE THAT COMES OUT OF THE STOPPER. I ALSO HAD THIS HAPPEN WHEN I WAS WITH CLINICIAN THE OTHER DAY. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17071391 ↗
• MalfunctionJun 6, 2023Defective Component; Defective Component

  IT WAS REPORTED, 3 OF CLINICIAN'S PICCS TODAY HAVE HAD THE SAME ISSUE. AGAIN ITS LEAKING AROUND THE WIRE THAT COMES OUT OF THE STOPPER. I ALSO HAD THIS HAPPEN WHEN I WAS WITH CLINICIAN THE OTHER DAY. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17071390 ↗
• MalfunctionJun 6, 2023Defective Component; Defective Component

  IT WAS REPORTED, 3 OF CLINICIAN'S PICCS TODAY HAVE HAD THE SAME ISSUE. AGAIN ITS LEAKING AROUND THE WIRE THAT COMES OUT OF THE STOPPER. I ALSO HAD THIS HAPPEN WHEN I WAS WITH CLINICIAN THE OTHER DAY. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17071389 ↗
• MalfunctionMay 16, 2023Material Frayed; Material Frayed

  IT WAS REPORTED "THE CLINICIAN WAS FEEDING INTRODUCER OVER GUIDEWIRE. SHE FELT RESISTANCE SO SHE WITHDREW GUIDEWIRE AND INTRODUCER AT THE SAME TIME. SHE NOTICED FRAYED WIRE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942351 ↗
• MalfunctionMay 12, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED A 4FR DL POWERPICC PROVENA INSERTED IN THE RIGHT UPPER ARM BRACHIAL VEIN ON (B)(6) 2023. ON (B)(6) THE CATHETER WAS TPA'D IN BOTH LUMENS. A CHEST X-RAY WAS REQUESTED AND SHOWED A KINK IN THE UPPER 1/3 OF THE UPPER ARM ON (B)(6) 2023. PICC DWELL TIME WAS 41 DAYS. PICC WAS PULLED BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924409 ↗
• MalfunctionMay 12, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED A 4FR DL POWERPICC PROVENA INSERTED IN THE LEFT UPPER ARM BASILIC VEIN ON (B)(6)2022 WAS FOUND TO BE KINKED ON 12/17/2022 IN THE SUBCLAVIAN REGION AT THE STERNOCLAVICULAR JUNCTION. PICC DWELL TIME WAS 18 DAYS. PICC REMAINED IN PLACE FOR ANOTHER WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924407 ↗
• MalfunctionMay 12, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED A 4FR DL POWERPICC PROVENA INSERTED IN THE LEFT UPPER ARM BRACHIAL VEIN ON (B)(6) 2023 WAS FOUND TO BE KINKED ON (B)(6) 2023 IN THE UPPER 1/3 OF THE UPPER EXTREMITY PER X-RAY. BOTH LUMENS WERE SLUGGISH TO FLUSH AND TPA WAS INSTILLED TWICE. PICC DWELL TIME WAS 2 DAYS. A NEW PICC WAS PLACED IN THE RIGHT UPPER EXTREMITY BY IR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924405 ↗