PowerPICC Provena SOLO S1395108D3Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741155024), received between May 15, 2019 and Jul 3, 2025 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 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-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT SEALED LOT SAMPLE RETURNED WITH CONFIRMED SPLIT SHEATH TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396235 ↗
• MalfunctionJul 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, FOUR SEALED LOT SAMPLES RETURNED WITH CONFIRMED ABRUPT TRANSITION BETWEEN THE INTRODUCER SHEATH AND THE DILATOR. THIS REPORT ADDRESSES ALL FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387166 ↗
• MalfunctionJun 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AN ADDITIONAL SAMPLE WAS RETURNED WITH HAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205325 ↗
• MalfunctionApr 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT INTRODUCER NEEDLE IN KIT IS PEELING BACK ON ITSELF WHEN INSERTED IN PT THERE IS RESISTANCE WHICH IS NOT NORMAL. WHEN REMOVAL, ITS FOLDING BACK. THE ONLY INJURE THAT HAS HAPPENED WAS SOME INCREASED BLEEDING AT THE INSERTION SITE. PRESSURE WAS HELD AND HEMOSTASIS WAS OBTAINED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773476 ↗
• MalfunctionJan 13, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER OF A MIDLINE KIT WITH A SAFETY NEEDLE ISSUE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21140121 ↗
• MalfunctionOct 10, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT LEAKING AT THE T CONNECTOR ON THE PICC LINES THEY USED YESTERDAY. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION 10/02: LEAKING FROM STOPPER NOTED WHILE THE PICC WAS BEING FLUSHED DURING THE INSERTION PROCESS (B)(6) 2023. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908943 ↗
• MalfunctionOct 10, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT LEAKING AT THE T CONNECTOR ON THE PICC LINES THEY USED YESTERDAY. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION (B)(6): LEAKING FROM STOPPER NOTED WHILE THE PICC WAS BEING FLUSHED DURING THE INSERTION PROCESS (B)(6) 2023. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908940 ↗
• MalfunctionJul 12, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT TRIPLE LUMEN PICC ARE HAVING ISSUES WITH THE LITTLE RUBBER PIECE WHERE GUIDEWIRE IS PULLED THROUGH AFTER WE CUT THE CATHETER, IT IS NOT ALLOWING US TO FLUSH THE LINE (NO PRESSURE SUPPORT) NOR ARE WE ABLE TO GET BLOOD RETURN FROM IT UNTIL WE PLACED A FINGER OVER THAT RUBBER HUB. THERE WAS NO SIGNIFICANT DELAY IN PROCEDURE AND NO URGENT OR LIFE THREATENING EFFECTS TO THE PATIENT. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Insufficient Information

  MAUDE report 17313064 ↗
• MalfunctionFeb 2, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "THE T LOCK CONNECTOR EXTENSION SET FEELS CHEAP AND SEEMS TO LEAK." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284343 ↗
• MalfunctionDec 15, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT A PROVEN A PICC FRACTURED WHEN THEY WERE TURNING A PATIENT. ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED LINE FRACTURED WHILE PATIENT BEING TURNED ON SIDE; LINE ACCIDENTLY TUGGED. CATHETER HAD BEEN SECURED WITH A STATLOCK. PICC WAS REMOVED AND NEW LINE PLACED. CAUSED ADDITIONAL PROCEDURE TIME FOR PATIENT AND CARE TEAM. CUSTOMER REPORTED NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992615 ↗
• MalfunctionNov 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "AFTER REMOVING THE DILATOR AND THREADING OVER WIRE, REPLACED DILATOR INTO INTRODUCER AND THREADING OVER WIRE MET RESISTANCE AT PUNCTURE SITE, AFTER REMOVING INTRODUCER FROM WIRE NOTED THAT INTRODUCER WAS DAMAGED AT TIP." DATE OF OCCURRENCE: ON (B)(6) 2022. PLACEMENT DATE: ON (B)(6) 2022. WAS THE PRODUCT USED ON A PATIENT? YES. WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. NEW INTRODUCER USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708067 ↗
• MalfunctionJan 27, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "COMPLETED DRESSING CHANGE AND WHEN I FLUSHED IT NO BLOOD RETURN AND DIFFICULT TO FLUSH. CATHFLOW NO RESULTS. WHEN FLUSHING FELT LIKE IT WAS MALPOSITIONED. OBTAIN X-RAY. CATHETER APPEARED TO BE KINKED IN THE SUBCLAVIAN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13373636 ↗
• MalfunctionDec 29, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "3CG WIRE/STYLET BROKE OFF DURING INSERTION. WIRE WAS RECOVERED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114375 ↗
• MalfunctionDec 9, 2021Material Frayed; Material Frayed

  IT WAS REPORTED A PIECE OF THE STYLET WIRE BROKE OFF COMPLETELY AFTER BENDING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968329 ↗
• InjuryDec 1, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "THE STYLET WIRE BROKE DURING INSERTION OF THE PICC AND A PIECE OF THE WIRE HAS REMAINED IN THE PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12911209 ↗
• MalfunctionAug 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "LINE WAS PLACED AND THEN THE NURSE REPORTED THAT THERE WAS CONTINUAL LEAKING, THERE WAS A PINHOLE FRACTURE IN THE CATHETER WALL AT THE HUB CATHETER CONNECTION." ADDITIONAL INFORMATION RECEIVED VIA SALESFORCE "5FR TL PICC INSERTED (B)(6) 2021 10:28. VAT NOTIFIED (B)(6) 2021 17:35 OF PICC LEAKING FROM INSERTION SITE. VAT TEAM NOTIFIED OF CONTINUED LEAKAGE (B)(6) 2021 19:49 AND AGAIN AT 0400, DIFFICULTY FULLY ASSESSING DUE TO PATIENT BEING IN PRONE POSITION. VAT ARRIVED AT BEDSIDE FOR FURTHER EVALUATION OF LINE AFTER PATIENT WAS SUPINE. LEAKAGE NOTED FROM SMALL PINHOLE RUPTURE IN CATHETER WALL AT HUB-CATHETER CONNECTION. SMALL, SHARP PIECE OF MATERIAL FROM CATHETER HUB SEAM MATCHES UP WITH HOLE AND EROSION MARKS IN SIDEWALL OF CATHETER. PICC REPLACEMENT REQUIRED. OVERWIRE EXCHANGE PROCEDURE COMPLETED W/O INCIDENT. PATIENT HAS PNEUMONIA DUE TO COVID-19 VIRUS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377347 ↗
• InjuryJul 22, 2021Material Frayed; Material Frayed

  IT WAS REPORTED VIA MS&S "HE STATES PLACED 5F TL POWER PICC ON (B)(6) 2021. SHE REPORTS THAT THE GUIDEWIRE WITH THE 3CG MAGNET BROKE OFF INTO THE PATIENT DURING THE INSERTION OF THE PICC. A CARDIAC CATH WAS PERFORMED TO ATTEMPT TO RETRIEVE THE BROKEN OFF PIECE FROM THE PATIENT BUT WAS UNSUCCESSFUL. THEY ARE TRANSFERRING THE PATIENT TO ANOTHER FACILITY. NO ADVERSE EFFECTS NOTED TO PATIENT AS OF TODAY." MS&S RESPONSE "DISCUSSED POSSIBLE CAUSES SUCH AS ACCIDENTLY NICKING THE STIFFENING STYLET WHEN CUTTING THE PICC, PULLING THE GUIDEWIRE BACK WHILE THE NEEDLE IS HELD IN PLACE OR GUIDEWIRE GETTING HUNG UP ON A VALVE. ADVISED THE CUSTOMER TO HOLD ON THE TO GUIDEWIRE AND ANY OTHER PARTS OF THE KIT HE STILL HAS IN ORDER TO RETURN THEM TO COMPLAINTS IF REQUIRED. CASE FORWARDED TO PRODUCT COMPLAINTS VIA EMAIL."

  Patient problems: Foreign Body In Patient

  MAUDE report 12214433 ↗
• MalfunctionJun 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "BENT WIRE. SUCCESSFUL INSERTION BUT WIRE BENT UPON REMOVAL." ON (B)(6) 2021: THE RETURNED DEVICE WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008882 ↗
• MalfunctionJun 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED KINKING IN PICC LINE. PICC WAS PLACED IN THE LEFT ARM. NO ADDITIONAL INFORMATION PROVIDED. ADD INFO RCVD 05/24/2021: DATE OF OCCURRENCE: (B)(6) 2021. WAS THERE PATIENT HARM REPORTED?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971295 ↗
• MalfunctionNov 12, 2020Detachment of Device or Device Component

  IT WAS REPORTED THAT ON THE MORNING OF (B)(6) 2020 WHEN USING A POWERPICC PROVENA ON A PATIENT, ONE OF THE VALVES DETACHED FROM THE PICC. THERE WAS NO PATIENT HARM AND THE DEVICE WAS NOT CONNECTED TO ANY FLUIDS. ADDITIONAL INFORMATION RECEIVED 11/4/2020: DEVICE WAS PLACED (B)(6) 2020 AND REMOVED (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10831716 ↗
• MalfunctionNov 12, 2020Material Twisted/Bent; No Flow

  IT WAS REPORTED "PICC LINE KINKED WITHIN THE PATIENTS ARM AND PREVENTED CATHETER FLOW." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10828838 ↗
• MalfunctionOct 14, 2020Material Twisted/Bent

  IT WAS REPORTED THE PICC WAS INSERTED (B)(6) 2020. IT WAS RETRACTED ON (B)(6) 2020. WHEN IT KINKED, PICC WAS REMOVED ON (B)(6) 2020 WHEN IT KINKED AGAIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10677300 ↗
• MalfunctionOct 14, 2020Malposition of Device

  IT WAS REPORTED INSERTED THE PICC WAS INSERTED 9/8 AND ON 9/11 IT WAS REMOVED DUE TO CATHETER MALPOSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10677214 ↗
• MalfunctionOct 14, 2020Material Deformation; Malposition of Device; Material Deformation

  IT WAS REPORTED THE PICC WAS INSERTED 7/4, 7/6 PULLED BACK 1-2CM, THEN REPLACED 7/7 FOR IJ MALPOSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10677129 ↗
• MalfunctionOct 14, 2020Malposition of Device

  IT WAS REPORTED THE PICC WAS INSERTED 7/3, 7/9 PULLED BACK 1-2CM, THEN REPLACED 7/12 FOR IJ MALPOSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10677128 ↗