PowerPICC Provena S1385108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741112720), received between Sep 14, 2016 and Feb 24, 2026 — classified as 4 injuries, 34 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-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Device Markings/Labelling Problem

  IT WAS REPORTED BY CUSTOMER THAT WHEN THE CENTRAL LINE DRESSING NURSE WENT TO CHANGE THE DRESSING AND RETRACT THE CATHETER BACK THE 2 CM, THERE WERE NO MARKS FOUND ON THE CATHETER. THIS PARTICULAR PICC WAS PLACED (B)(6) 2026. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428706 ↗
• MalfunctionJul 17, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE SAFETY ON THE 21G STRAIGHT NEEDLE DID NOT ENGAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538101 ↗
• MalfunctionFeb 6, 2025Activation Problem; Activation Problem

  IT WAS REPORTED VIA MEDWATCH "DURING INSERTION OF TRIPLE LUMEN PICC LINE, GREEN NEEDLE THAT USED TO ACCESS THE VEIN WAS NOT SAFELY ENGAGED ONCE REMOVED. IT FLEW OFF AND NEEDLE WAS NOT SAFELY SECURED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327738 ↗
• MalfunctionJan 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, PICC KINKED. PATIENT REFERRED TO IR. CATHETER INSERTED IN RIGHT BASILIC WITH A 38CM TOTAL CATHETER LENGTH AND 1CM LEFT EXTERNAL. KINK OCCURRED IN IN THE INNOMINATE REGION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075662 ↗
• MalfunctionApr 14, 2023Defective Component; Defective Component

  IT WAS REPORTED, LEAKING AT T PORT CONNECTOR UPON FLUSHING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16747011 ↗
• MalfunctionApr 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER "WE HAVE HAD 2 BARD KITS WITH DEFECTIVE INTRODUCERS. WHEN WE SPLIT THEM TO TEAR AWAY FROM THE CATHETER THEY ARE NOT BREAKING AWAY EVENLY AND A SMALL PIECE OF THE RED PLASTIC IS STAYING AROUND THE CATHETERS. WE ARE NOT ABLE TO PULL THEM OFF EASILY AND HAVE HAD TO CUT THEM AWAY; WE ARE WORRIED ABOUT POSSIBLE CATHETER DAMAGE. LINE WAS SALVAGED AS FAR AS WE KNOW. I HAD TO CUT IT AWAY WITH THE BLADE, NO APPARENT HOLES AT THAT TIME." THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112493 ↗
• MalfunctionApr 14, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER "WE HAVE HAD 2 BARD KITS WITH DEFECTIVE INTRODUCERS. WHEN WE SPLIT THEM TO TEAR AWAY FROM THE CATHETER THEY ARE NOT BREAKING AWAY EVENLY AND A SMALL PIECE OF THE RED PLASTIC IS STAYING AROUND THE CATHETERS. WE ARE NOT ABLE TO PULL THEM OFF EASILY AND HAVE HAD TO CUT THEM AWAY; WE ARE WORRIED ABOUT POSSIBLE CATHETER DAMAGE. LINE WAS SALVAGED AS FAR AS WE KNOW. I HAD TO CUT IT AWAY WITH THE BLADE, NO APPARENT HOLES AT THAT TIME." THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112485 ↗
• MalfunctionMar 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Device Dislodged or Dislocated; Incorrect, Inadequate or Imprecise Result or Readings; Device Dislodged or Dislocated

  IT WAS REPORTED THE PICC WAS PLACED USING SHERLOCK 3CG AND WAS DISCOVERED TO BE 6CM OFF IN TIP LOCATION, DESPITE HAVING BEEN CONFIRMED IN THE PROPER PLACE BY THE 3CG TECHNOLOGY. IT WAS STATED THIS WAS DISCOVERED BY AN INCIDENTAL X-RAY THAT THE PATIENT RECEIVED UNRELATED TO THE PICC PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726411 ↗
• MalfunctionMar 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Device Dislodged or Dislocated; Incorrect, Inadequate or Imprecise Result or Readings; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PICC PLACED USING SHERLOCK 3CG WAS DISCOVERED TO BE 6CM OFF IN TIP LOCATION, DESPITE HAVING BEEN CONFIRMED IN THE PROPER PLACE BY 3CG TECHNOLOGY. INCORRECT PLACEMENT DISCOVERED BY INCIDENTAL X-RAY THAT THE PATIENT RECEIVED UNRELATED TO THE PICC PLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726178 ↗
• MalfunctionAug 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "5FR PROVENA TL PICC WAS PLACED FOR ABOUT A WEEK. PATIENT WAS VENTED AND SEDATED. THE PICC WAS SECURED WITH A SECURACATH. PATIENT WENT FOR CT SCAN WHERE A HOLE IN THE PICC CLOSET TO THE PATIENT'S SKIN WAS DISCOVERED AT ABOUT THE 3CM MARK AND THE PICC WAS OUT ABOUT 4CM. THE RED PORT WAS THE LUMEN WITH THE HOLE AND IT WAS DISTAL TO THE SECURACATH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389189 ↗
• MalfunctionMay 7, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THE WHITE LUMEN WOULD NOT DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790886 ↗
• MalfunctionMar 19, 2021Material Frayed; Material Frayed

  IT WAS REPORTED WHILE INSERTING PICC, THERE WAS SOME RESISTANCE. PICC LINE REMOVED AFTER UNABLE TO PASS THROUGH, WAS KINKED SLIGHTLY. RN REMOVED STYLET FROM PICC. AFTER REMOVAL OF STYLET, WIRE BROKE ABOUT 1 INCH AT END. NEW PICC WAS OPENED AND USED FOR REST OF PROCEDURE. ALL OF WIRE ACCOUNTED FOR; NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530932 ↗
• MalfunctionDec 23, 2020Fracture; Material Frayed; Physical Resistance/Sticking; Material Frayed

  IT WAS REPORTED "TWO OF OUR VAST NURSES WERE INSERTING A PICC ON THE PATIENT¿S RIGHT ARM IN THE ICU ON (B)(6) 2020 UTILIZING S1385108D FROM LOT#REER0535. RESISTANCE ENCOUNTERED. DIFFICULTY THREADING CATHETER NOTED FROM PATIENT ANATOMY. FEW AREAS OF CATHETER AND WIRE BENDING WITH DIFFICULTY THREADING. WHEN ABANDONING ATTEMPT FOR INSERTION, SMALL AMOUNT OF WIRE NOTED TO PROXIMAL CATHETER TIP. UPON WITHDRAWING OF WIRE AT THE DISTAL END, WIRE AT THE PROXIMAL END STILL PRESENT. APPROXIMATELY 1-1.5 INCH WIRE FRACTURED FROM MAIN WIRE. COULD HAVE BEEN A SENTINEL EVENT IF THE WIRE WAS UNKNOWINGLY LEFT INSIDE. NO HARM DONE TO PATIENT BUT CERTAINLY A NEAR MISS."

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

  MAUDE report 11065949 ↗
• MalfunctionAug 5, 2020Defective Component; Defective Component

  IT WAS REPORTED ONE OF THE RNS HAD A DEFECTIVE MST WIRE YESTERDAY. ONCE THE WIRE WAS INSERTED THROUGH THE NEEDLE, THERE SEEMED TO BE A "BURR" ON THE WIRE - AS THE RN WAS MOVING THE WIRE INSIDE THE PATIENT'S VEIN TO CONFIRM THE VEIN PATHWAY, IT "DID NOT FEEL RIGHT", THEREFORE SHE ATTEMPTED TO REMOVE THE WIRE BACK THROUGH THE NEEDLE. SHE WAS UNABLE TO REMOVE IT. SHE THEN DECIDED IT WOULD BE BEST TO REMOVE THE NEEDLE AND WIRE TOGETHER INSTEAD OF FORCING THE WIRE THROUGH THE NEEDLE. SHE HAD DIFFICULTY REMOVING THE WIRE THROUGH THE PATIENT'S SKIN, AS IF THE WIRE WAS STUCK. SHE COULD VISUALIZE THE WIRE PULLING ON THE PATIENT'S SKIN. EVENTUALLY SHE WAS ABLE TO REMOVE THE WIRE INTACT. THE WIRE WAS INSPECTED, AND THERE IS DEFINITELY A DEFECT, THAT IS VISIBLE, AND PALPABLE. THERE WAS NO HARM TO THE PATIENT, WITH THE EXCEPTION OF REQUIRING A SECOND STICK. A NEW MST WIRE WAS USED FOR THE SECOND STICK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370866 ↗
• MalfunctionJun 11, 2020Defective Component; Defective Component

  IT WAS REPORTED "THE RUBBER STOPPER CAME COMPLETELY DETACHED FROM THE EXTENSION." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142716 ↗
• MalfunctionFeb 26, 2020Fluid/Blood Leak; Material Split, Cut or Torn

  THE PICC LINE WAS LEAKING AND ONCE REMOVED A SMALL NICK WAS VISIBLE ON THE LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9753312 ↗
• MalfunctionSep 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PROVENA WAS PLACED TPN INDICATION, STERILE PLACEMENT (B)(6)2019, US USED, LENGTH 45 CM, 1 INSERTION ATTEMPT. VAT ASSESSED AND IDENTIFIED LEAK IN LINE. THE LINE WAS REMOVED AND REPLACED. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9099198 ↗
• MalfunctionJul 17, 2019Flushing Problem

  IT WAS REPORTED THAT THE CATHETER WAS NOT FLUSHING, THE LINE WAS PULLED AND A CRIMP/KINK WAS NOTED IN THE CATHETER ROUGHLY 3-4CM FROM TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8800376 ↗
• MalfunctionFeb 27, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CAP BROKE OFF FROM PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8375449 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem

  THE FACILITY REPORTED A DVT TREND WITH PROVENA PICC LINES, PRODUCT CODE S1385108D. IT WAS STATED THE DVT REQUIRES CHANGE IN COURSE OF TREATMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE THIRD OF THREE DEVICES.

  Patient problems: Thrombosis

  MAUDE report 8318966 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem

  THE FACILITY REPORTED A DVT TREND WITH PROVENA PICC LINES, PRODUCT CODE S1385108D. IT WAS STATED THE DVT REQUIRES CHANGE IN COURSE OF TREATMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND OF THREE DEVICES.

  Patient problems: Thrombosis

  MAUDE report 8318959 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem

  THE FACILITY REPORTED A DVT TREND WITH PROVENA PICC LINES, PRODUCT CODE S1385108D. IT WAS STATED THE DVT REQUIRES CHANGE IN COURSE OF TREATMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST OF THREE DEVICES.

  Patient problems: Thrombosis

  MAUDE report 8318941 ↗
• MalfunctionJan 17, 2019Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A DRESSING CHANGE, THE NURSE NOTICED LEAKING. THE LINE WAS FLUSHED AND A HOLE IN THE PICC WAS OBSERVED. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8259349 ↗
• MalfunctionNov 1, 2018Material Twisted/Bent

  IT WAS REPORTED THAT AFTER SUCCESSFUL PLACEMENT OF A PROVENA CATHETER, THE TPS WIRE SHOWED AN UNUSUAL BEND IN THE DISTAL PORTION AFTER REMOVAL. 10/09/2018 - RETURNED WIRE IS KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8028681 ↗
• MalfunctionOct 10, 2018Retraction Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER UNSUCCESSFUL ATTEMPTS TO POSITION CATHETER IN THE SVC, THE CATHETER WAS RETRACTED AND BECAME RESISTANT. REPOSITIONING OF PATIENT ARM ALLOWED REMOVAL OF THE CATHETER IN ITS ENTIRETY, HOWEVER, DURING REMOVAL OF THE WIRE, NOTICED THE DISTAL PORTION WAS ALMOST SEVERED/SHEARED OFF. MD WAS NOTIFIED AND XRAYS PERFORMED. THERE WAS NO EVIDENCE OF RETAINED FOREIGN BODIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7954435 ↗