PowerPICC Provena SOLO S1395108D5Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00801741155222), received between Jan 23, 2019 and Oct 15, 2025 — classified as 4 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (13 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED A WIRE WAS FOUND INSIDE ONE OF THE LUMENS OF THE CATHETER. THE METAL OBJECT WAS NOTED AT THE END OF THE PICC LINE INSERTION AND BEFORE THE INITIAL DRESSING WAS APPLIED. THE STYLE WIRE WAS INTACT WHEN REMOVED. THE CONCERN WAS A METAL OBJECT NOTED INTERNALLY, IN THE WHITE PORT (PIGTAIL)OF THE PICC. THIS WAS NEAR THE AREA WHERE THE WHITE PIGTAIL MEETS THE PURPLE PLATFORM. THE PICC LINE WAS REMOVED, AND THE PATIENT REQUIRED AN ADDITIONAL PICC LINE TO PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288970 ↗
• MalfunctionJul 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT VAT CALLED TO REPLACE PICC LINE THAT PATIENT HAD REMOVED. PICC SUPPLIES WERE GATHERED, CONSENT WAS OBTAINED, AND PICC PROCEDURE WAS PERFORMED. UPON INSERTION OF THE PICC LINE AND FLUSHING IT WITH 10ML SYRINGES, RN NOTICED A PIN HOLE LEAK WHERE THE PURPLE HUB MEETS THE LAVENDER LINE. AFTER CONFIRMING THE LINE WAS DEFECTIVE AN OVER-THE-WIRE EXCHANGE WAS PERFORMED WITH A NEW PICC LINE OBTAINED BY THE SECONDING RN. THE EXCHANGE OCCURRED WITHOUT INCIDENT AND THE OVER-THE-WIRE PICC LINE WAS CONFIRMED TO HAVE NO DEFECTS/ISSUES AND FUNCTIONED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385495 ↗
• MalfunctionApr 4, 2025Activation Problem; Activation Problem

  IT WAS REPORTED CUSTOMER GETTING RID OF ALL THE SHARPS WENT TO SLIDE THE SAFETY ON THE GREEN BD NEEDLE AND THE SAFETY POPPED OFF THE NEEDLE INSTEAD. THE PRODUCT WAS NOT USED ON A PATIENT, AND NO HARM WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21779491 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PICC TEAM WAS ATTEMPTING AN OVER THE WIRE EXCHANGE OF A FIVE FRENCH TRIPLE LUMEN PROVENA POWER PICC. WHILE PREPPING THE NEW DEVICE, THE INSERTER NOTICED A SMALL PINHOLE IN ONE OF THE EXTENSION LEGS OF THE PICC. AS THEY FLUSHED WITH SALINE, THE SALINE BEGAN TO LEAK FROM THE HOLE. AT THIS POINT, THEY OPENED A NEW KIT IN ORDER TO OBTAIN A FUNCTIONING DEVICE. THERE WAS NO HARM TO THE PATIENT AND THE NEW DEVICE WAS PLACED WITHOUT ISSUE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21361052 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC LINE HAD A HOLE IN IT EXTERNAL TO PATIENT AT THE 0CM MARK. NO KNOWN INJURY OR NEGATIVE OUTCOME REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358951 ↗
• MalfunctionNov 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PICC WAS NON-FUNCTIONING AND NEEDED TO REMOVED DUE TO LEAKING FROM CATHETER NEAR THE 2CM MARK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136181 ↗
• MalfunctionJan 20, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED THE WIRE GOT TIED IN A KNOT AND WAS STUCK IN THE PATIENT'S ARM. CUSTOMER OBSERVED THAT THE WIRE IS "MUCH THINNER THAN IT USED TO BE". THE PATIENT REPORTEDLY HAD TORTUOUS VEINS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214613 ↗
• MalfunctionJan 19, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED THE WIRE GOT TIED IN A KNOT AND WAS STUCK IN THE PATIENT'S ARM. CUSTOMER OBSERVED THAT THE WIRE IS "MUCH THINNER THAN IT USED TO BE". THE PATIENT REPORTEDLY HAD TORTUOUS VEINS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16210191 ↗
• MalfunctionMay 12, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "PICC NURSE WENT TO INSERT PICC AND NOTICED A HUMAN HAIR INSIDE THE PACKAGING. SHE TOOK A PICTURE OF THE HAIR AND DISCARDED THE KIT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14382836 ↗
• MalfunctionMar 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THE MICRO EZ INTRODUCER SEEMED WEAKER THAN IN THE PAST. IT WAS STATED THAT IT BOWED UP ON ITSELF WHILE INSERTING INTO PATIENT. CUSTOMER HAD TO OPEN SEPARATE INTRODUCER DURING PICC PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13811052 ↗
• MalfunctionMar 10, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "THERE LOOKS TO BE WHITE PAINT ON THE PICC LINE ITSELF." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726087 ↗
• MalfunctionNov 18, 2021Break; Break

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "A TRIPLE LUMEN PICC WAS ATTEMPTED ON A PATIENT IN CRITICAL CARE. VEIN WAS ACCESSED WITH NO PROBLEM, PICC WAS INTRODUCED AND THREADED INTO THE VEIN SMOOTHLY, WITH NO RESISTANCE MET UNTIL MID-CLAVICULAR. PATIENT WAS REPOSITIONED PICC WITHDRAWN SLIGHTLY AND ATTEMPTED TO FLUSH THE PICC WHILE ADVANCING. AGAIN RESISTANCE WAS MET MID-CLAVICULAR, AT THIS TIME PICC WAS NOT ABLE TO BE FLUSHED OR ASPIRATED FOR BLOOD RETURN. DUE TO PATIENTS CRITICAL STATIS THE PICC PROCEDURE WAS TO BE TERMINATED DUE TO NOT BEING ABLE TO THREAD PICC TO DESIRED LOCATION. AS PICC WAS BEING REMOVED AT THE 45CM EXTERNAL MARK RESISTANCE WAS MET AND THE PICC WAS NO LONGER ABLE TO BE PULLED OUT OF PATIENT (8CM REMAINED INTERNAL). 3CG WIRE WAS REMOVED FROM CATHETER AT THIS TIME WITH NO RESISTANCE, WIRE INITIALLY SEEMED TO BE INTACT WHEN ASSESSED. ICU RESIDENT BROUGHT INTO ROOM TO ASSIST PICC TEAM WITH REMOVAL, ALSO WAS MET WITH RESISTANCE AND UNABLE TO REMOVE. VAT RECOMMENDED VASCULAR SURGERY AND IR BE CONSULTED. DRESSING APPLIED OVER PICC AND SITE TILL VASCULAR SURGERY ARRIVED. PICC TEAM SPOKE WITH ICU RESIDENT FOR AN ARM, AND CHEST XRAY. CXR DONE FIRST INITIALLY AND NOT WIR

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12839089 ↗
• MalfunctionNov 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "TRIPLE LUMEN PICC INSERTED ON CRITICAL CARE PATIENT (COVID) ON (B)(6) 2021 WITH NO ISSUES. PICC CONFIRMED WITH 3CG TECHNOLOGY, AND CXR DONE CONSECUTIVELY AFTER INSERTION DUE TO CRITICAL CARE STATUS. PICC NOTE TO BE FINE ON CXR UNTIL (B)(6) 2021 WHERE THE PICC WAS LOOPED MID-CLAVICULAR 1ST INTERCOSTAL SPACE AND TIP STILL IN SVC. I MET WITH ONE OF THE RADIOLOGISTS TO LOOK AT ALL THE CXR¿S AND CT SCAN TO SEE WHEN PICC LOOPED ON ITSELF ((B)(6) 2021) ALSO DISCUSSED WITH RADIOLOGIST POSSIBILITIES ON HOW THIS COULD HAVE HAPPENED. PICC HAD TO BE REPLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12839082 ↗
• InjurySep 23, 2021Defective Component; Defective Component

  IT WAS REPORTED "FRACTURED STYLET FROM PICC LEFT FOREIGN BODY IN PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12519469 ↗
• InjurySep 22, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "AFTER PICC PLACED, VISUALLY INSPECTED STYLET AND NOTED TIP WAS MISSING, FRACTURED STYLET POST PICC PLACEMENT, HAD TO REMOVE FOREIGN BODY FROM PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12517161 ↗
• InjurySep 2, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT WHEN REVIEWING CXR NEEDED FOR PLACEMENT CONFIRMATION IT WAS NOTED THAT TWO METALLIC FRAGMENTS WERE NOTED. PATIENT CAME BACK INTO ED ON (B)(6) 2021 WITH COMPLAINTS OF SHORTNESS OF BREATH. PATIENT HAD TO BE TAKEN TO INTERVENTIONAL RADIOLOGY FOR REMOVAL OF THE METALLIC FRAGMENTS. THE LARGER SEGMENT WAS REMOVED BUT THE SMALLER FRAGMENT WAS UNABLE TO BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12418439 ↗
• MalfunctionAug 12, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "WE HAD AN ISSUE WITH A PICC TODAY WHERE ONE OF MY COWORKERS WAS SETTING UP TO PLACE A TRIPLE LUMEN PICC AND WHEN SHE WAS PRIMING HER LINE SHE NOTICED THAT SHE COULD NOT FLUSH THE WHITE LUMEN. SHE DISCONNECTED AND RECONNECTED ALL POSSIBLE CONNECTIONS AND STILL COULD NOT FLUSH THE WHITE LUMEN. WE JUST STARTED OVER WITH A NEW PICC KIT. WE LOOKED MORE CLOSELY AND NOTICED THERE IS A 3.5 CM WIRE LOOKING OBJECT STUCK IN THE LUMEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315732 ↗
• InjuryJul 30, 2021Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED "WE HAD A FRACTURED SHERLOCK WIRE YESTERDAY. RETAINED FOREIGN BODY IN PATIENT. WIRE NOT SAVED FOR EVALUATION. DURING PICC PLACEMENT, HAD DIFFICULT PASSING GUIDEWIRE INITIALLY. GUIDEWIRE STOPPED WITH 16 CM REMAINING. PLACED INTRODUCER AND PICC. PICC WITH 20 CM OUT. REPOSITIONING PT WAS ABLE TO GET GUIDWIRE TO ADVANCE AND PICC TO ADVANCE COMPLETELY. HOWEVER, DID NOT SHOW THAT THE PICC DROPPED. WHEN I ATTEMPTED TO RESET BY PULLING OUT THE MAGNET WIRE, IT WAS DIFFICULT / IMPOSSIBLE TO PULL BACK. PULLED OUT PICC SLOWLY WHILE SIMULTANEOUSLY PULLING BACK ON MAGNET WIRE, AND WAS EVENTUALLY ABLE TO REMOVE THE WIRE ENOUGH TO RESET THE SHERLOCK. ADVANCED LINE WITH MAGNET WIRE WITH PICC COMPLETELY IN AND RECEIVED PWAVE. WHEN I REMOVED THE MAGNET WIRE I NOTICED CURLING, LIKELY FROM THE FRICTION OF PULLING AND CANNOT CONFIRM IF MAGNET IS FULLY INTACT." ADDITIONAL INFORMATION RECEIVED: "IMAGING WAS PERFORMED TO INCLUDE CXR WITH ARM INCLUSION AND CT. FOUND IN BICEP AREA NEAR THE INSERTION SITE. VASCULAR SURGERY OPTED NOT TO PERFORM SURGICAL RETRIEVAL."

  Patient problems: Foreign Body In Patient

  MAUDE report 12255614 ↗
• MalfunctionJul 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC WAS NON-FUNCTIONING AND NEEDED TO REMOVED DUE TO LEAKING FROM CATHETER NEAR THE 2CM MARK." NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12138676 ↗
• MalfunctionJun 10, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "PICC TEAM WAS HAVING TROUBLE ADVANCING THE 5F TRIPLE LUMEN PICC MUCH BEYOND THE SHOULDER. WHEN THE NURSE PULLED THE PICC LINE OUT AFTER TRYING SEVERAL TIMES TO ADVANCE IT, SHE NOTICED THAT THE WIRE WAS STICKING OUT OF THE END OF THE PICC. SHE WAS CERTAIN THAT SHE HAD PULLED THE WIRE BACK BEFORE INSERTING THE PICC SO SHE PULLED IT BACK AGAIN AND NOTICED THAT THE WIRE WAS STILL STICKING OUT THE END OF THE PICC. I ADVANCED THE WIRE FORWARD AND IT CAME OUT IN TWO PIECES. THE TEAM TOOK THE PATIENT DOWN TO IR TO CONFIRM THAT THERE WAS NO WIRE IN THE PATIENT AND TO TRY TO PLACE THE PICC UNDER FLUOROSCOPY. THE PATIENT'S VEIN MADE A COMPLETE LOOP, WHICH IS WHY THEY WERE UNABLE TO ADVANCE THE PICC. THE WIRE BROKE INSIDE THE PICC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977722 ↗
• MalfunctionJun 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "MY TEAM IS REPORTING ISSUES WITH OUR 5 FR TRIPLE LUMEN PICC LINES, LOT REEZ3810. THEY ARE KINKING IN THE ARM AND WE'VE HAD TO REPLACE 3 IN THE LAST WEEK." THIS REPORT ADDRESSES THE SECOND PATIENT. PICC PLACED (B)(6) 2021 WITHOUT COMPLICATION. (B)(6) 2021 ALTEPLACE GIVEN FOR OCCLUSION (B)(6) 2021 0951- 2 LUMENS NOT FLUSHING. DRESSING CHANGED, XRAY ORDERED FOR VERIFICATION OF PLACEMENT (B)(6) 2021 1005- XRAY NOTED KINKING OF PICC LINE AT INSERTION SITE FOR LENGTH OF OVER 2CM PER RADIOLOGIST. (B)(6) 2021 OTW EXCHANGE DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939500 ↗
• MalfunctionJun 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "MY TEAM IS REPORTING ISSUES WITH OUR 5 FR TRIPLE LUMEN PICC LINES, LOT REEZ3810. THEY ARE KINKING IN THE ARM AND WE'VE HAD TO REPLACE 3 IN THE LAST WEEK." THIS REPORT ADDRESSES THE THIRD PATIENT. PICC PLACED (B)(6) 2021 AT 1242 WITHOUT COMPLICATION 1335 PICC LINE WILL NOT FLUSH OR DRAW BLOOD 1414 IVT RN AT BEDSIDE TO ASSESS. LINE RE-ADJUSTED, WITHDRAWN UNTIL ABLE TO OBTAIN BLOOD RETURN BUT THEN UNABLE TO FLUSH, KINKING NOTED AT 9CM MARK ON LINE WHEN PULLED BACK. LINE REMOVED AND PICC LINE STARTED ON ALTERNATE ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939497 ↗
• MalfunctionJun 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "MY TEAM IS REPORTING ISSUES WITH OUR 5 FR TRIPLE LUMEN PICC LINES, LOT REEZ3810. THEY ARE KINKING IN THE ARM AND WE'VE HAD TO REPLACE 3 IN THE LAST WEEK. MY TEAM SEEMS TO THINK IT IS A CATHETER RELATED ISSUE." THIS REPORT ADDRESSES THE FIRST PATIENT. PICC PLACED (B)(6) 2021 @ 1100 WITHOUT COMPLICATION. (B)(6) 2021 AT 1300 IVT PAGED FOR DRAINAGE FOR SITE. RN NOTED KINK IN CATHETER AT INSERTION SITE, DRESSING CHANGED. (B)(6) 2021 1730 IVT PAGED FOR SLUGGISH BLOOD DRAWS/DIFFICULTY WITH FLUSHING. AGAIN NOTED KINK AT INSERTION SITE, DRESSING CHANGED. CHEST XRAY TO VERIFY PLACEMENT (KINKED PICC LINE VISIBLE ON CHEST XRAY JUST PROXIMAL TO INSERTION SITE ALTHOUGH THIS WAS NOT INDICATED IN INITIAL RADIOLOGY REPORT IT WAS FOUND AFTER THE FACT BY IVT RN.) (B)(6) 2021 PICC LINE WILL NOT DRAW/FLUSH, RETRACTED UNTIL ABLE TO OBTAIN BLOOD RETURN. (B)(6) 2021 PICC LINE CONTINUES TO DRAIN FROM INSERTION SITE, CONTINUED ISSUE WITH FLUSHING. PICC DC'D AND REPLACED ON ALTERNATE ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939493 ↗
• MalfunctionJun 3, 2021Material Frayed; Material Frayed

  IT WAS REPORTED A WIRE HAS A DEFECT. IT BROKE WHEN TRYING TO ADVANCE. WIRE APPEARED TO BE FRAYED. ADD INFO RCVD 5/13/2021: IT WAS REPORTED THAT THE NURSE HAD TROUBLE THREADING PICC THROUGH SHOULDER AREA. WHEN HE PULLED THE PICC OUT OF THE PATIENT FOR INVESTIGATION THE WIRE WAS HANGING OUT OF THE TIP OF THE PICC AND WHEN PULLED ON, A PIECE CAME OUT THAT HAD BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11932330 ↗
• MalfunctionMar 20, 2021Material Frayed; Material Frayed

  IT WAS REPORTED WIRE TIP BROKE OFF AND WAS UNABLE TO BE LOCATED. PICC WAS DISSECTED AND NURSE BELIEVES IT GOT STUCK IN THE VALVE. TOOK X-RAYS TO SEE IF IT WAS IN PATIENT BUT IT WAS NOT FOUND. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536704 ↗