PowerPICC Provena S1173108D5Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741155130), received between Oct 9, 2020 and Sep 2, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50565729 ↗
• MalfunctionJan 19, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THE CLINICIAN INSERTED A PICC ON (B)(6) 2023. HE WAS ABLE TO PUNCTURE THE VEIN, BUT UNABLE TO ADVANCE THE GUIDEWIRE, SO HE PULLED IT BACK TOGETHER W/ THE NEEDLE, BUT MET RESISTANCE AND NOTED A SHEAR AT THE ELASTIC COIL PART OF THE GUIDEWIRE. HE THEN DECIDED TO NICK THE PATIENT'S SKIN AND WAS ABLE TO SUCCESSFULLY REMOVE BOTH THE NEEDLE AND THE GUIDEWIRE. I DROPPED ANOTHER NEEDLE AND HE WAS ABLE TO SUCCESSFULLY INSERT THE PICC LINE. RESPONSE RECEIVED 01/09/2024: AS FAR AS WE KNOW, THERE ARE NO HEALTH CONSEQUENCES RELATED TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545582 ↗
• MalfunctionAug 9, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY CUSTOMER, THAT GUIDEWIRE WOULD NOT ADVANCE. WHEN ATTEMPTING TO PULL OUT IT, GOT STUCK. A TISSUE SUBSTANCE APPEARS TO BE STUCK ON WIRE CLOSE TO TIP. PATIENT NEEDED GUIDEWIRE REMOVED BY TEAM OF PHYSICIANS. PATIENT NOT HARMED. NO OTHER INFORMATION PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17490895 ↗
• MalfunctionAug 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "THE INTRODUCER TOO EASILY BUCKLING AND BECOMING BENT OR THE GREY PEEL-A-WAY END BEGINS TO CURL BACK ON ITSELF PREVENTING THE INTRODUCER FROM ENTERING THE VEIN WALL. WE WERE ABLE TO EASILY INSERT THE INTRODUCER THROUGH THE SKIN OVER THE GUIDE WIRE FOR ABOUT 1 INCH AFTER MAKING A SKIN NICK. HOWEVER, WHEN WE TRIED TO ADVANCE THE INTRODUCER THROUGH THE VEIN, WE MET RESISTANCE. WHEN WE TRIED TO ADVANCE THE INTRODUCER THROUGH THE VEIN, WE MET RESISTANCE. WE MADE A LARGER NICK BUT HAD THE SAME OUTCOME. WHEN WE REMOVED THE INTRODUCER I COULD SEE AND FEEL THE GRAY EDGE HAD ROLLED BACK ON ITSELF. WE HAD TO OPEN AN ADDITIONAL PICC KITS TO RETRIEVE ANOTHER INTRODUCER. WHEN WE RETRIEVED A NEW INTRODUCER, IT ADVANCED EASILY LIKE IT'S SUPPOSED TO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204199 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED AN INTRODUCER BUNCHING UP. WE HAD TO USE THE INTRODUCER FROM THE MICROINTRODUCER KIT TO COMPLETE LINE INSERTION. THIS RESULTED IN BLEEDING AT THE SITE WHERE PRESSURE HAD TO HELD FOR 5-10 MINUTES BEFORE DRESSING COULD BE APPLIED. WE WERE PLACING A SINGLE LUMEN AT THE TIME. ADD INFO RCVD 01/25/2021: UNABLE TO USE PRODUCT AFTER FIRST ATTEMPT, PRODUCT SECURED, INTRODUCER FROM MICROINTRODUCER KIT USED TO PLACE LINE. NO PATIENT HARM WAS NOTED OR REPORTED, PRESSURE HAD TO BE HELD AT SITE FOR GREATER THAN 10 MIN BEFORE DRESSING COULD BE APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960301 ↗
• MalfunctionNov 4, 2020Difficult to Insert; Material Deformation

  IT WAS REPORTED THE MICROINTRODUCER WAS NOT SMOOTH AND HAD BULGED EDGES WHICH CAUSED THE PATIENT PAIN UPON INSERTION. ADDITIONAL INFORMATION RECEIVED 10-06-2020: "DIAGNOSIS: BRAIN ABSCESS, NO INFECTIOUS DISEASE, 'WHEN PLACING PICC HAD TROUBLE WITH MICROINTRODUCER; WHEN INSPECTING INTRODUCER NOTICED BULGED EDGES. DUE TO THE BULGED EDGE UNABLE TO GET INTRODUCER THROUGH THE SKIN OF PATIENT. WE HAD TO DROP A MICROEZ MICROINTRODUCER KIT TO FINISH THE PICC LINE PLACEMENT. THIS HAS HAPPENED ON SEVERAL OCCASIONS."

  Patient problems: Pain

  MAUDE report 10787836 ↗
• MalfunctionOct 29, 2020Structural Problem

  IT WAS REPORTED THE MICROINTRODUCER IS NOT SMOOTH AND HAS BULGED EDGES. IT WAS STATED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: Pain

  MAUDE report 10758422 ↗
• MalfunctionOct 29, 2020Material Too Rigid or Stiff

  IT WAS REPORTED THE MICRO INTRODUCER IS NOT SMOOTH AND HAS BULGED EDGES. IT WAS STATED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: Pain

  MAUDE report 10758415 ↗
• MalfunctionOct 29, 2020Material Deformation

  IT WAS REPORTED THE MICROINTRODUCER IS NOT SMOOTH AND HAS BULGED EDGES. IT WAS STATED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: Pain

  MAUDE report 10758307 ↗
• MalfunctionOct 23, 2020Difficult to Insert; Material Deformation

  IT WAS REPORTED "INTRODUCER WILL NOT ENTER THE SKIN UPON INSPECTION THERE IS A PROBLEM WITH THIS IT HAS A BEVELED EDGE INSTEAD OF A FLAT EDGE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731392 ↗
• MalfunctionOct 9, 2020Fracture

  IT WAS REPORTED "POSSIBLE MICRO FRACTURE INTERNAL LENGTH 1-3 CM PROXIMAL TO INSERTION SITE WITH 3FR SL POWERPICC". ADDITIONAL INFO. RECEIVED 09/18/2020: "9/16-RIGHT BASILIC 3FR SL PICC PLACED @ BEDSIDE WITHOUT DIFFICULTY, NO ADVERSE EVENTS DURING PROCEDURE, NO COMPLAINTS OF DISCOMFORT FROM PATIENT DURING LINE PLACEMENT. ONE HOUR POST LINE PLACEMENT, IV ANTIBIOTIC INFUSION WAS STARTED USING INFUSION PUMP. PATIENTS RIGHT ARM 6-8 CM DISTAL TO INSERTION SITE BEGAN TO SWELL WHICH CREATED SOME PATIENT DISCOMFORT. NURSE WAS NOTIFIED BY PATIENT, AS PUMP DID NOT ALARM. NURSE NOTED THE SWELLING AND STOPPED INFUSION. INFUSION WAS RESTARTED AT A SLOWER RATE. SWELLING APPEARED EVEN WHEN INFUSION WAS DECREASED. 9/17-VAT NOTIFIED AND ASKED TO ASSESS SITE. US DOPPLER ORDERED TO R/O THROMBUS WHICH WAS NEGATIVE, PRIOR TO CONTACTING VAT.THERE WAS NOTED SWELLING COMPARED TO LEFT ARM EVEN AFTER INFUSION HAD BEEN ON HOLD FOR 4+ HOURS. VAT COLLABORATED WITH PROVIDER, BEDSIDE NURSE, AND PATIENT. LINE REMOVED AND SAVED FOR EVALUATION. " "WAS THERE PATIENT HARM REPORTED?: NO HARM BUT DELAY IN DISCHARGE."

  Patient problems: Swelling

  MAUDE report 10659357 ↗