PowerPICC Provena S1274108D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00801741155055), received between Jul 3, 2019 and Feb 27, 2026 — classified as 6 injuries, 81 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT WHILE INSERTING PICC, CLINICIAN FELT RESISTANCE IN THE AREA OF SUBCLAVIAN. SHE PULLED THE PICC OUT TO INSPECT AND TRY TO REINSERT AND NOTICED A KINK VISIBLE NEAR THE END OF THE TRIMMED CATHETER, AND THE CATHETER MATERIAL APPEARED WHITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470131 ↗
• MalfunctionDec 29, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE T PORT EXTENSION ON A 3CG PICC WAS LEAKING. THE PICC WAS HARD TO FLUSH AND ASPIRATE. THEY WERE ABLE TO FLUSH AND ASPIRATE DIRECTLY FROM THE HUB. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919364 ↗
• MalfunctionSep 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, PICC PLACED IN RIGHT UPPER ARM BRACHIAL VEIN, TRIMMED TO 47 CM WITH 2 CM OUT TO USE SECURACATH AS STABILIZATION DEVICE. PLACED AT 1245 PM AND AT 0430 PM THE LINE WAS REPORTED AS HARD TO FLUSH UNLESS RETRACTED FROM INSERTION SITE. 8/27 IT WAS REPORTED THAT THE LINE DID NOT HAVE BLOOD RETURN, LINE WAS REMOVED AND REPLACED. X-RAY OF THE ARM SHOWS MAJOR Z-TRACKING/KINK IN LINE AND AFTER REMOVAL, KINKS SEEN AT 9 CM AND 11 CM. PICC REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065415 ↗
• MalfunctionSep 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT LINE PLACED MID-THIGH, FULL 55 CM PICC UNTRIMMED WITH 2-3 CM OUT OF THE PATIENT (SECURACATH USED AS STABILIZATION). THREE DAYS AFTER PLACEMENT, ONE LUMEN WAS PATENT AND ONE WAS POSITIONAL. CATHFLO WAS ADMINISTERED SEVERAL TIMES. PICC REMOVED DUE TO MULTIPLE ACCESS POINTS AND KINK AT 8-9 CM MARK WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018697 ↗
• MalfunctionSep 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PICC HAD ISSUES WITH THE PEEL AWAY MICRO INTRODUCER "SPLINTERING" WHILE THE NURSE WAS ATTEMPTING TO INSERT. WE OPENED A NEW KIT AND USED THE INTRODUCER FROM THE NEW KIT WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22995132 ↗
• MalfunctionJul 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED PICC WAS PLACED ON (B)(6) 2025 AND REMOVED (B)(6) 2025. SOON AFTER PLACEMENT THEY HAD REPORTED ISSUES ABOUT SLUGGISH BLOOD RETURN AND FLUSHING. THEY ORDERED CATHFLO WHICH WAS UNSUCCESSFUL AND AN XRAY THAT SHOWED THE PICC CURLED UP ON ITSELF. PICC REMOVED AFTER 48 HOURS AND A NEW ONE WAS PLACED IN THE OPPOSITE ARM. KINK AROUND THE 7.5 CM MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22424199 ↗
• MalfunctionJun 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE PICC PLACED JUNE 2 AND REMOVED JUNE 2 DUE TO KINKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323035 ↗
• MalfunctionJun 10, 2025Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED, MICRO INTRODUCER MALFUNCTIONED AND THE ORANGE PIECE BROKE AWAY FROM THE GRAY SHEATH WHILE PLACING A PICC. THE VAT NURSE HAD TO DIG THE PLASTIC PIECE OUT OF THE PATIENT. PATIENT WAS FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181456 ↗
• MalfunctionApr 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN INSERTING A PICC THAT THE INTRODUCER WOULD NOT ADVANCE OVER THE WIRE AND INTO THE VEIN. PULLED IT AND LOOKED AND IT HAS A BIG LIP/ROLLED EDGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859835 ↗
• InjuryMar 28, 2025Material Frayed; Material Frayed

  IT WAS REPORTED BY MEDSUN, PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] PLACED AT BEDSIDE IN RIGHT BASILIC VEIN UNDER SEDATION. PROCEDURE PROGRESSED AS NORMALLY DONE USING SHERLOCK 3CG SENSING SYSTEM. FOLLOW UP CHEST X-RAY SHOWED SMALL RADIOGRAPHICALLY PRESENT CURVED SHAPE. CXR COMPLETED, NOTED THE SAME FINDING ON CXR [CHEST XRAY]. CHEST CT SHOWED A CURVILINEAR METALLIC FOREIGN BODY WITHIN A DISTAL SUBSEGMENTAL BRANCH PULMONARY ARTERIAL OF THE RIGHT MIDDLE LOBE. THIS FOREIGN BODY MAY NOT BE ENTIRELY OCCLUSIVE AS VESSEL OPACIFICATION IS SEEN DISTAL TO THE FOREIGN BODY. THE TEAM IS NOW DECIDING WHETHER IT IS MORE OF A RISK TO LEAVE IT IN OR REMOVE IT. ADDITIONAL INFORMATION RECEIVED 03/20/2025: IT WAS REPORTED, THE RISKS OF REMOVING IT OUTWEIGH THE BENEFITS AT THIS POINT IN TIME. THE PIECE IS IN THE PATIENT¿S ARTERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21718709 ↗
• InjuryMar 27, 2025Material Frayed; Material Frayed

  IT WAS REPORTED; PEDIATRIC INTENSIVE CARE NURSE PLACED A POWERPICC WHERE THE TIP DISLODGED IN THE PATIENT'S VASCULAR SYSTEM. NURSE STATES SHE PLACED AT THE BEDSIDE, SHE THINKS 3 - 3.5CM OF THE TIP CAME OFF OF THE DEVICE INTO THE PULMONARY ARTERY AND IS NOW IN THE LUNG. SHE IS UNABLE TO EXPLAIN HOW THE TIP OF THE DEVICE CAME OFF INTO THE PATIENT'S VASCULAR SYSTEM. THE TIP OF THE INTERNAL GUIDEWIRE IS NOW IN A SUBSEGMENTAL BRANCH OF THE PULMONARY ARTERY IN THE RIGHT MIDDLE LOBE. THE PATIENT IS CURRENTLY STABLE. IT APPEARS THERE IS STILL BLOOD FLOW THROUGH THE VESSEL. REMOVING THIS MAY CAUSE MORE HARM THAT IF IT WERE REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21713798 ↗
• MalfunctionMar 26, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THERE WAS CONCERN FOR FRACTURING OF INTERNAL STYLET ON INSERTION. ANOTHER PICC HAD TO BE PLACED. NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699994 ↗
• MalfunctionMar 25, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE INTRODUCER SPLIT INTO THREE PIECES WHEN ATTEMPTING TO BREAK AWAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692629 ↗
• MalfunctionFeb 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, CATHETER HAS VISIBLE KINKS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21359017 ↗
• MalfunctionFeb 6, 2025Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED AT PICC PLACEMENT INTRODUCER BROKE AND UNABLE TO TEAR DURING PICC INSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329219 ↗
• MalfunctionJan 31, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE SECURELOC INTRODUCER NEEDLES HAVE BEEN COMING APART AT THE SAFETY AND AREN¿T SAFETYING THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED. AN EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282682 ↗
• MalfunctionJan 23, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE GREEN SAFETY CAP ON INTRODUCED NEEDLE THE ENTIRE CAP CAME OFF AND BECAME A SAFETY ISSUE. THERE WAS NO INJURY OR COMPLICATIONS FROM THE DEFAULT OF THE SAFETY ON THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219315 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "4FR POWER DOUBLE LUMEN PICC PLACED 2024 BY VASCULAR ACCESS TEAM. WETNESS NOTED UNDER DRESSING BY PATIENT AND PATIENT NOTIFIED BEDSIDE NURSE. VAT CONSULT PLACED AND VAT ASSESSED PICC AS WELL AS CONTACTED PROVIDER TO LOOP THEM INTO BROKEN PICC WITH TPN INFUSING. PICC REMOVED 2024 AT 0131 DUE TO "HOLE IN CATHETER" WITHOUT DIFFICULTY. UNABLE TO REMOVE SECUREACATH AT TIME OF PICC REMOVAL DUE TO PATIENT DISCOMFORT. STERILE DRESSING APPLIED AND TO REATTEMPT IN MORNING. NEW 4FR POWER DOUBLE LUMEN PICC PLACED. NO HARM REPORTED."

  Patient problems: Discomfort

  MAUDE report 21035446 ↗
• MalfunctionOct 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT DOUBLE LUMEN PLACE IN RIGHT ARM OF PATIENT. PATIENT WAS FEELING PAIN AFTER PLACEMENT SO PICC WAS REMOVED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: Pain

  MAUDE report 20584708 ↗
• MalfunctionSep 18, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT DIRTY NEEDLE TIP EXPOSED. NO HARM TO PATIENT OR HCP, NO NEEDLE STICK INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20253003 ↗
• MalfunctionSep 10, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT INTRODUCER WILL NOT GO INTO PATIENT WITHOUT MASSIVE FORCE, HAD TO DROP ANOTHER KIT TO COMPLETE PROCEDURE. THERE WERE NO DELAYS, NEGATIVE CONSEQUENCES, OR IMPACT TO THE PATIENT. 8/12/2024 - TWO DEVICES WERE RETURNED FOR EVALUATION; DURING EVALUATION ONE OF THEM EXHIBITED AN UNEVEN DISTAL TIP EDGE. THIS FILE ADDRESSES THAT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182504 ↗
• InjurySep 6, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE SAFETY ON THE NEEDLE DID NOT STAY LOCKED ONCE ENGAGED WHICH EXPOSED THE NEEDLE AND CAUSED A NEEDLE STICK. HCP WAS STUCK WITH NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20157101 ↗
• MalfunctionAug 15, 2024Misconnection; Misconnection

  IT WAS REPORTED BY CUSTOMER THAT THE STATLOCK - LEFT WING BROKEN, OUTSIDE EDGE OF LEFT WING VERY SHARP. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991573 ↗
• MalfunctionJul 22, 2024

  MISSING GUIDE WIRE IN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) KIT. WHEN THE REGISTERED NURSE (RN) WENT TO PREPARE THE GUIDE WIRE, IT WAS DISCOVERED THE HOLDING TUBE WAS EMPTY WITH NO WIRE IN IT. INVOLVED KIT/CONSUMABLES WERE NOT SAVED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792570 ↗
• MalfunctionJun 25, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THEY HAVE HAD THREE NEEDLE SAFETIES (GREEN BARRELS) SLIDE OFF AND EXPOSE THE NEEDLE ENTIRELY WHILE ATTEMPTING TO SAFETY. ADDITIONAL INFORMATION RECEIVED 6/11/2024: IT WAS REPORTED THE GREEN SAFETY BARREL THAT SLIDES FORWARD ON THE SECURELOC NEEDLE SLID OFF OF THE NEEDLE. IT IS SUPPOSED TO STOP AND LOCK INTO PLACE TO SHROUD THE EXPOSED NEEDLE POST-INSERTION BUT THIS DID NOT HAPPEN AND IT CONTINUED SLIDING FORWARD AND COMPLETELY OFF OF THE NEEDLE. THERE WAS NO HARM OR ADVERSE EVENT TO THE PATIENT OR THE HEALTHCARE PROVIDER. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611117 ↗