PowerPICC Provena S1274108PDRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00801741134166), received between Jun 15, 2017 and Dec 17, 2025 — classified as 9 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, THE DARK GRAY PIECE BUNCHED UP ON THE INTRODUCER AND WOULD NOT GO INTO THE VEIN. IT WAS A REPLACEMENT KIT. ADDITIONAL INFORMATION: NO ADVERSE EFFECTS ON THE PATIENT OR HEALTH CARE PROVIDERS. I HAD TO DROP A NEW INTRODUCER SET ON THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830947 ↗
• MalfunctionDec 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, THE DARK GRAY PIECE BUNCHED UP ON THE INTRODUCER AND WOULD NOT GO INTO THE VEIN. IT WAS A REPLACEMENT KIT. ADDITIONAL INFORMATION: NO ADVERSE EFFECTS ON THE PATIENT OR HEALTH CARE PROVIDERS. I HAD TO DROP A NEW INTRODUCER SET ON THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830133 ↗
• MalfunctionNov 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE NURSE WAS INSERTING A PICC AND THE INTRODUCER WENT THROUGH THE SKIN ON A PEDIATRIC PATIENT BUT GOT HUNG UP ON THE 1 CM INTO THE TISSUE. THE NURSE HAD TO GET A MICROEZ INSERTION KIT AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596003 ↗
• MalfunctionOct 28, 2025Material Deformation; Material Deformation

  IT WAS REPORTED NURSE WAS INSERTING THE DILATOR INTO THE PEDIATRIC PATIENT FOR PICC PLACEMENT AND COULD NOT GET IT TO GO THROUGH. IT WAS HUNG UP ON THE PATIENT'S SKIN. SHE ENDED UP GETTING A NEW MICRO-INTRODUCER KIT TO HELP HER INSERT. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23409354 ↗
• MalfunctionJul 31, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THE PEEL AWAY INTRODUCER MUSHROOMS OUT, FLARES. NO PATIENT HARM BUT CAUSED A LONGER PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. TWO DEVICES WERE RETURNED FOR INVESTIGATION. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19877486 ↗
• MalfunctionJul 31, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT PEEL AWAY INTRODUCER MUSHROOMS (FLARES) OUT CAUSING A LONGER TRAUMATIZING PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. TWO DEVICES WERE RETURNED FOR INVESTIGATION. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19873782 ↗
• MalfunctionFeb 17, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER, 'WIRE IN THE KIT IS NOT SMOOTH ON INSERTION'. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16396496 ↗
• MalfunctionFeb 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER, 'PEEL AWAY ROUTINELY BUCKLES'. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16375782 ↗
• MalfunctionOct 7, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "3FR. PICC THAT HAD A BROKEN WIRE OVER THE WEEKEND." ADDITIONAL INFO. RECEIVED (B)(6) 2021 "DIFFICULTY ADVANCING PICC, NOTED TO HAVE BROKEN WIRE AFTER MULTIPLE ATTEMPTS TO PASS THROUGH INTRODUCER. WHEN PULLED OUT, WIRE NOTED TO BE BROKEN, OTHER PIECE OF WIRE RETRIEVED FROM PICC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591016 ↗
• MalfunctionFeb 19, 2021Material Deformation; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE DEVICE RETURNED FOR EVALUATION WAS FOUND KINKED.

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

  MAUDE report 11349160 ↗
• InjuryNov 18, 2020Break

  IT WAS REPORTED THE WIRE BROKE INSIDE THE PATIENT. THE RN STATED, "I BELIEVE IT WAS THE STYLET, BUT NOT SURE YET. IT IS FROM A PICC PLACED A MONTH AGO, AND THE PIECE IS NOW LODGED IN THE PULMONARY ARTERY." ADD INFO RCVD 10/27/2020: DIFFICULTY ADVANCING PICC PAST SHOULDER WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: STATLOCK WAS THERE PATIENT HARM REPORTED?: SO FAR PT IS ASYMPTOMATIC. WAITING TO SEE IF WIRE CAN BE REMOVED IN IR.

  Patient problems: Foreign Body In Patient

  MAUDE report 10864654 ↗
• MalfunctionOct 29, 2020Fluid/Blood Leak; Material Puncture/Hole; Communication or Transmission Problem

  IT WAS REPORTED "THE CATHETER HAD A HOLE IN THE LINE THAT CAUSED ALL THE SALINE TO LEAK OUT AND NOT ALLOW THE SHERLOCK TO PICK UP THE SIGNAL FROM THE CATHETER."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10759225 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PICC WAS PLACED ON (B)(6) 2020 AND PATIENT DEVELOPED A DVT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombus

  MAUDE report 9985436 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PICC WAS PLACED ON (B)(6) 2020 AND PATIENT DEVELOPED A DVT.

  Patient problems: Thrombus

  MAUDE report 9983613 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PICC WAS PLACED ON (B)(6) 2020 AND PATIENT DEVELOPED A DVT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombus

  MAUDE report 9983440 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PICC WAS PLACED ON (B)(6) 2020 AND PATIENT DEVELOPED A DVT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombus

  MAUDE report 9983369 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PICC WAS PLACED ON (B)(6) 2020 AND PATIENT DEVELOPED A DVT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombus

  MAUDE report 9983140 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PICC WAS PLACED ON (B)(6) 2020 AND PATIENT DEVELOPED A DVT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombus

  MAUDE report 9983139 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PICC WAS PLACED ON (B)(6) 2020 AND PATIENT DEVELOPED A DVT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombus

  MAUDE report 9983137 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PICC WAS PLACED ON (B)(6) 2020 AND PATIENT DEVELOPED A DVT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombus

  MAUDE report 9983133 ↗
• MalfunctionDec 6, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE GALT MICROINTRODUCERS IN THE PROVENA KITS ARE PEELING UP, CREATING A LIP WHEN INSERTING. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9428470 ↗
• MalfunctionNov 6, 2019Material Deformation; Material Deformation

  FACILITY REPORTED, "WE TRIED THE WAY WE HAVE BEEN PRACTICING FOR A WHILE NOW WHICH I BELIEVE IS BEST PRACTICE BUT TAKING THE INSIDE OF THE INTRODUCER AND SLIDING IT OVER THE WIRE TO STRETCH IT OUT ENOUGH TO HOPEFULLY NOT HAVE TO MAKE A NICK BUT THE INTRODUCER BUNCHES UP AND STARTS TO SHRED WITH MINIMAL PRESSURE APPLIED. EVEN WITH NICKS WE HAVE BEEN MOST OF THE TIME UNABLE TO EVEN GET THIS INTRODUCER IN AND HAVING TO DROP A BETTER INTRODUCER LIKE THE GALT." IT WAS REPORTED THAT TWO INTRODUCERS HAVE BUNCHED UP AND SHREDDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9288053 ↗
• MalfunctionNov 6, 2019Material Deformation; Material Deformation

  FACILITY REPORTED, "WE TRIED THE WAY WE HAVE BEEN PRACTICING FOR A WHILE NOW WHICH I BELIEVE IS BEST PRACTICE BUT TAKING THE INSIDE OF THE INTRODUCER AND SLIDING IT OVER THE WIRE TO STRETCH IT OUT ENOUGH TO HOPEFULLY NOT HAVE TO MAKE A NICK BUT THE INTRODUCER BUNCHES UP AND STARTS TO SHRED WITH MINIMAL PRESSURE APPLIED. EVEN WITH NICKS WE HAVE BEEN MOST OF THE TIME UNABLE TO EVEN GET THIS INTRODUCER IN AND HAVING TO DROP A BETTER INTRODUCER LIKE THE GALT." IT WAS REPORTED THAT TWO INTRODUCERS HAVE BUNCHED UP AND SHREDDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9288047 ↗
• MalfunctionJun 8, 2018Hole In Material; Nonstandard Device

  PER MEDWATCH: "FOUND OUT ABOUT THIS ON (B)(6) 2018 FROM THE PICC TEAM. DEFECT OR FAILURE CREATED AN UNSAFE CONDITION." PATIENT WAS BROUGHT BACK TO FACILITY BY PARENTS ON (B)(6) 2017 WITH A HOLE IN THE PICC LINE IN THE LEG EXTENSION ABOVE THE HUB FOR THE NEEDLELESS CONNECTOR. PATIENT HAD TO GO TO SURGERY TO HAVE A BROVIAC PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7585011 ↗
• MalfunctionApr 26, 2018Leak/Splash; Nonstandard Device

  IT WAS REPORTED BY THE FACILITY THAT THERE WAS A LEAK AT THE HUB NEAR THE INJECTION CAP OF THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7466148 ↗