PowerPICC Provena S1294108D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00801741155109), received between Jun 26, 2020 and Apr 22, 2026 — classified as 6 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Break; Crack

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD AN ISSUE WITH A PICC CATHETER THAT BROKE SOON AFTER PLACEMENT. IT APPEARS THERE MUST HAVE BEEN A SLIGHT FRACTURE IN THE HUB OF ONE OF THE LUMENS THAT CAUSED IT TO BREAK WHEN IT WAS ACCESSED FOLLOWING PLACEMENT. THE PATIENT REQUIRED A SECOND PROCEDURE TO REPLACE THE LINE. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960743 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC OUTSIDE OF THE PATIENT LEAKING FROM THE RED PIG TAIL. DID NOT LEAD TO AN INFILTRATION. EXTERNAL PARTIAL CATHETER BREAKAGE WAS VISUALIZED BY THE STAFF AND LEAKING WAS NOTED. THE EVENT DID NOT CAUSE A DELAY IN TREATMENT AND THERE WERE NO PATIENT SYMPTOMS OR INJURY. CATHETER SUCCESSFULLY REMOVED WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698338 ↗
• MalfunctionSep 16, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  ADDITIONAL INFORMATION: NO HARM OR OTHERWISE NEGATIVE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066774 ↗
• MalfunctionSep 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DOUBLE LUMEN PICC LINES ARE KINKING. THE EXACT NUMBER OF DEVICES INVOLVED WAS NOT PROVIDED BY THE COMPLAINANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22973900 ↗
• MalfunctionSep 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DOUBLE LUMEN PICC LINES ARE KINKING. THE EXACT NUMBER OF DEVICES INVOLVED WAS NOT PROVIDED BY THE COMPLAINANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22973248 ↗
• MalfunctionJul 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THEY HAVE HAD SOME ISSUES WITH INTRODUCERS RECENTLY WITH ROLLING DOWN WHEN TRYING TO INSERT. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676275 ↗
• InjuryJun 30, 2025Break; Break

  IT WAS REPORTED PICC LINE WAS PLACED SUCCESSFULLY. LINE STARTED TO SHOW SIGNS OF COMPLICATION AND DURING A UNRELATED CHEST XRAY THEY REALIZE THE LINE HAD BROKEN AROUND 4 CM FROM THE TIP OF THE CATHETER. LINE WAS REMOVED BY CATH LAB IN TWO SEGMENTS. ADDITIONAL INFORMATION: ON (B)(6) 2025, IT WAS DISCOVERED THAT A PATIENT'S DOUBLE LUMEN PICC HAD BROKEN INSIDE THE PATIENT ABOUT 5 CM ABOVE THE TIP. THE PICC WAS INSERTED ON (B)(6) 2025 BY A PSVMC IV THERAPY RN AT BEDSIDE VIA 3CG IN THE ICU. ON (B)(6) 2025, A ROUTINE CHEST XRAY DISCOVERED THE BROKEN LINE. THE LINE HAD BECOME SYMPTOMATIC AS THE NURSING TEAM WAS HAVING DIFFICULTY GETTING BLOOD RETURN. DR. WITH IR PERFORMED THE PROCEDURE ON (B)(6) 2025. IV RN WAS AT THE BEDSIDE DURING THE PROCEDURE TO REPLACE THE PICC LINE. A NEW PICC LINE WAS SUCCESSFULLY PLACED. NO DETECTABLE HARM TO THE PATIENT, ASIDE FROM THE CATH LAB PROCEDURE REQUIRED TO CORRECT THE ISSUE. FEMORAL ACCESS WAS REQUIRED TO REMOVE THE BROKEN END OF THE LINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22359286 ↗
• MalfunctionJun 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT A KINKED 4FRENCH WAS FOUND AT THE EXTERNAL TO THE PATIENT AT THE 29 CM MARK, A VERY SIGNIFICANT KINK THERE. PICC HAD TO BE REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301628 ↗
• MalfunctionJun 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED 4FR DL PICC CATHETER KINKED IN AXILLARY AREA. UNABLE TO RESOLVE WITH RETRACTION, NEEDED TO BE REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22243412 ↗
• MalfunctionApr 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER, BOTH LUMENS WOULD NOT FLUSH OR DRAW, BOTH LUMENS TREATED WITH ALTEPLASE FOR 4 HOURS FROM 1100 THE MORNING OF THIS ISSUE. THE LINE WOULD WORK IF THE SKIN WAS PULLED TOWARD THE ELBOW AND SLIGHTLY UP TOWARD THE BICEP. DRESSING CHANGE WAS DONE TO TRY AND REPOSITION THE EXTERNAL PORTION OF THE CATHETER, NO CHANGE. THE LINE WAS FLUSHED AS IT WAS PULLED, 1 CM AT A TIME, REQUIRING A NEW EVL OF 8CM TO ALLOW THE LINE TO FUNCTION. CXR WAS DONE AND THE TIP IS NOT AT THE SUBCLAVIAN VEIN/SVC JUNCTION. PROVIDER NOTIFIED AND REPLACEMENT OF THE LINE WAS ORDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753754 ↗
• MalfunctionMar 10, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED BY CUSTOMER THAT LEADS ON 3CG WERE DEFECTIVE. WIRES NOT VISIBLY NOTICED TO BE DAMAGED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21567044 ↗
• MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, PICC WAS SUCCESSFULLY PLACED IN JANUARY, NURSE ASSESSED LINE AND CHECKED FOR PATENCY. WHEN THE LINE WAS FLUSHED, THEY NOTICED THE DRESSING BECAME SATURATED AND FOUND A HOLE BETWEEN THE HUB AND THE LINE. PICC WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528951 ↗
• MalfunctionFeb 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED DEVICES HAS VISIBLE KINKS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363657 ↗
• MalfunctionFeb 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON 1/16 LINE WAS REPORTED TO BE LOOPED IN THE NECK VIA X-RAY. PICC LINE REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362956 ↗
• MalfunctionJan 18, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THE NEEDLE FROM A DOUBLE PICC LINE KIT SAFETY MECHANISM MALFUNCTIONED. THERE WERE NO ADVERSE EVENTS OR INJURIES TO THE PATIENT OR THE HEALTHCARE PROFESSIONAL. NO SAMPLE WAS KEPT AS THEY WERE NEEDLES AND HAD ALREADY BEEN IN CONTACT WITH THE PATIENT. THEY WERE PLACED IN THE SHARPS CONTAINER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186714 ↗
• MalfunctionJan 17, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE FROM A DOUBLE PICC LINE KIT SAFETY MECHANISM MALFUNCTIONED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21184023 ↗
• MalfunctionJan 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER, PICC NURSE NOTICED THE MICRO INTRODUCER LOOKED FRAYED IN PACKAGING, THE WHITE TIP LOOKS TO HAVE A SNAG. NURSE DESCRIBED NO ISSUES WHEN ATTEMPTING TO INSERT BUT DROPPED NEW INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057912 ↗
• InjuryDec 30, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT SAFETY SLID OFF END OF NEEDLE UPON ATTEMPTING TO ENGAGE SAFETY MECHANISM. NO IMPACT TO PATIENT. RN PERFORMING WAS STUCK BY CONTAMINATED NEEDLE DUE TO FAULTY EQUIPMENT. NO FURTHER HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21045115 ↗
• InjuryDec 30, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER WAS UNABLE TO SAFETY NEEDLE AFTER INSERTION RESULTING IN A NEEDLESTICK TO RN. SAFETY MECHANISM DID NOT ENGAGE AND SLID OFF.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21043387 ↗
• MalfunctionDec 30, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER, UNABLE TO SAFETY NEEDLE AFTER INSERTION, SAFETY MECHANISM DID NOT ENGAGE AND SLID OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043375 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER PICC PLACED 4/5 AND ENDED UP WITH A DVT. ADDITIONAL INFORMATION RECEIVED 04/25/2024: IT WAS REPORTED BY THE CUSTOMER THE DVT TO THE AFFECTED EXTREMITY OF THE PATIENT, ANTICOAGULATION AND EXTENDED STAY DUE TO DVT TREATMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19274820 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PICC ENDED UP WITH DVT. THE PLACEMENT DATE WAS (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION 04/25/2024: IT WAS REPORTED DVTS TO THE AFFECTED EXTREMITY OF THE PATIENT. ANTICOAGULATION AND EXTENDED STAY DUE TO DVT TREATMENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19264874 ↗
• MalfunctionAug 16, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THE PICC THEY HAD TO PULL THE WIRE OUT, FLUSH THE LUMEN AND THEN REINSERT THE WIRE. THEY DID THIS BECAUSE ALL OF THE FLUSH WAS COMING OUT THE TOP INSTEAD OF DOWN THE LUMEN TO CLEAR THE LINE. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023 THE LEAKING AROUND THE END HAPPENED BEFORE THE PICC WAS EVER PLACED INTO THE PT. I THINK THE END CAP IS NOT SECURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17556542 ↗
• MalfunctionJul 25, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT PATIENT PULLED OUT PICC. WHEN PATIENT PULLED PICC OUT HE PULLED ONE OF THE EXTENSION LEGS OFF. NO PATIENT HARM. ADDITIONAL INFORMATION FROM THE CUSTOMER ON 7-18-2023: IT WAS REPORTED "WE HAD A PATIENT IN ICU THAT DEVELOPED SOME ICU PSYCHOSIS ON NIGHT SHIFT AND PULLED THE RED LUMEN, COMPLETE SEVERING FROM THE FROM THE WING. THERE WERE NO COMPLICATIONS NOTED. THE PICC WAS REMOVED AND REPLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391732 ↗
• MalfunctionApr 27, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED BY THE CUSTOMER "THE PICC CANNOT BE USED FOR POWER INJECTION. THERE WAS NO HARM BUT THE PATIENT NEEDED TO GET STUCK WITH AN IV. PATIENT HAS CANCER." IT WAS STATED THE PATIENT DOES NOT HAVE AN INFECTIONS DISEASE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824109 ↗