PowerPICC Provena S1173108PDRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741134104), received between Jan 24, 2018 and May 18, 2026 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT SHERLOCK GAVE A GREEN BOX INDICATOR DEMONSTRATING THE PICC WAS IN THE CORRECT POSITION BUT CXR SHOWING IT WAS MALPOSITIONED. OUR POLICY IN PEDIATRICS IS WE ALWAYS CONFIRM WITH A CXR, EVEN WITH SHERLOCK CONFIRMATION PRIOR TO USE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211199 ↗
• MalfunctionAug 24, 2025Material Deformation; Material Deformation

  A DEVICE WAS RETURNED FOR EVALUATION WITH CUSTOMER STATING THE MICROINTRODUCER SHEATH/DILATOR ASSEMBLY IS CURVED/BENT. ADDITIONAL INFORMATION: THE DEVICE WAS BENT WHILE ATTEMPTING TO DILATE THE INSERTION SITE ON A PATIENT. THEY LIKELY FELT ADDED PRESSURE. A NEW KIT WAS OPENED FOR A NEW INTRODUCER. (B)(6) 2025: IT WAS FOUND DURING AN INVESTIGATION THE DILATOR SHAFT WAS OBSERVED TO BE CURVED, AND THE SHEATH TIP WAS OBSERVED TO BE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881432 ↗
• InjuryMay 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA MEDSUN: THE PATIENT CONTINUED TO HAVE ABDOMINAL DISTENSION THE DAY OF THE INCIDENT FOR WHICH AN ABDOMINAL ULTRASOUND WAS PERFORMED WHICH SHOWED "FLORID INFLAMMATORY CHANGES NOTED IN THE RIGHT LOWER QUADRANT WITH APERISTALTIC THICK-WALLED TUBULAR STRUCTURE PRESENT. CT OF ABDOMEN AND PELVIS WITH INTRAVENOUS CONTRAST IS RECOMMENDED TO BETTER ASSESS THE ETIOLOGY OF THE TUBULAR STRUCTURE WITH ASSOCIATED INFLAMMATORY CHANGES." CT SCAN WITH IV CONTRAST WAS PERFORMED, CONTRAST PUSHED THROUGH THE PICC/MIDLINE CATHETER [PERIPHERALLY INSERTED CENTRAL CATHETER]. THE RESULTING IMAGE SHOWED, "CONTRAST MATERIAL INSTILLED WITHIN THE ANTERIOR PELVIS CONSISTENT WITH AN EXTRALUMINAL PLACEMENT OF THE CATHETER TIP." I WAS INFORMED IMMEDIATELY UPON THIS FINDING AND THE PATIENT WAS IMMEDIATELY BROUGHT BACK TO THE PICU [PEDIATRIC INTENSIVE CARE UNIT]. THE PATIENT REMAINED ON BIPAP [BILEVEL POSITIVE AIRWAY PRESSURE] SETTINGS WITHOUT ESCALATION IN RESPIRATORY SUPPORT. THE ABDOMEN UPON ARRIVAL WAS SOFT, MILDLY DISTENDED, BUT APPEARED NON-TENDER. PEDIATRIC SURGERY AND VASCULAR SURGERY WERE BOTH CONSULTED AND AGREED TO KEEP THE CATHETER IN PLACE UNTIL THE MORNING. PREVIOUSLY INFUSING PPN [P

  Patient problems: Abdominal Distention; Perforation of Vessels

  MAUDE report 22066479 ↗
• MalfunctionFeb 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER, ¿VEIN WAS ACCESSED EASILY IN THE PEDS OR AND WIRE PASSED VERY SMOOTHLY. PRIOR TO THREADING THE INTRODUCER OVER THE WIRE, I CHECKED TO MAKE SURE IT WAS IN THE LOCKED POSITION. WHEN ADVANCING THE INTRODUCER THROUGH THE SKIN, IT BUCKLED AND THE STIFF PORTION WITHIN THE PEEL-AWAY-SHEATH SLID BACK. I REMOVED IT FROM THE WIRE AND ATTEMPTED TO PLACE IT BACK INTO THE LOCKED POSITION. HOWEVER, WHEN I WENT TO PUT IT BACK INTO THE LOCKED POSITION, IT CONTINUED TO SPIN. IT LOOKED LIKE THE LITTLE PLASTIC PEG HAD SNAPPED OFF MAKING IT UNABLE TO BE LOCKED INTO PLACE. IT JUST FREELY SPUN AROUND. I FEEL LIKE THE PLASTIC WAS VERY WEAK AND ALLOWED THE INTRODUCER TO SLIP BACK THROUGH THE SHEATH.¿ ADDITIONAL INFORMATION: IT WAS REPORTED BY THE CUSTOMER, ¿THIS ULTIMATELY DID NOT AFFECT THE PATIENT OUTCOME AS WE WERE ABLE TO SUCCESSFULLY ACCESS AN ADJACENT VEIN AND PLACE THE PICC. HOWEVER, WE ATTEMPTED TO ADVANCE A NEW INTRODUCER OVER THE ORIGINAL WIRE, BUT THE VEIN WAS NO LONGER VIABLE UNDER ULTRASOUND. THIS DID NECESSITATE RE-ACCESSING. TO MY KNOWLEDGE, NO CHANGES TO CLINICAL SIGNS OR HEALTH IMPACTS WERE OBSERVED. THERE WAS NO ADVERSE EVENT OR INJURY TO THE PATIENT OR H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305167 ↗
• InjuryJun 10, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT PRE LOADED STYLET BROKE OFF INTO THE PATIENT DURING PLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19505747 ↗
• MalfunctionFeb 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PEEL AWAY INTRODUCERS ARE WEAK AND KEEP HAVING DIFFICULTY PLACING THEM AND THEY MUSHROOM OUT AND FALL APART WHERE DILATOR MEETS SHEATH. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18717930 ↗
• MalfunctionMar 26, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A HAIR IN THE PICC KIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11577516 ↗
• 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 9983373 ↗
• MalfunctionOct 17, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE FACILITY IS ISSUES WITH THE INTRODUCERS ARE "SHREDDING" MAKING THEM DIFFICULT TO USE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203992 ↗
• MalfunctionOct 17, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE FACILITY IS ISSUES WITH THE INTRODUCERS ARE "SHREDDING" MAKING THEM DIFFICULT TO USE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203989 ↗
• InjuryNov 15, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A 3FR SL PICC INSERTED IN LEFT BRACHIAL VEIN ON (B)(6) 2018 BY RN. ARTERY WAS PUNCTURED DURING PROCEDURE WITH AN ESTIMATED BLOOD LOSS OF 2ML.

  Patient problems: Blood Loss; Extravasation

  MAUDE report 8075635 ↗
• MalfunctionNov 1, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PICC WAS PLACED USING THE MODIFIED SELDINGER TECHNIQUE INTO THE LEFT CEPHALIC VEIN. IT WAS STATED THE HUB BROKE OFF THE LUMEN. THE PICC WAS REPLACED OVER EXCHANGE WIRE INTO THE LEFT BRACHIAL VEIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8028464 ↗
• MalfunctionMay 30, 2018Fluid/Blood Leak; Nonstandard Device

  IT WAS REPORTED THAT A LINE WAS PLACED ON (B)(6) 2018 AND REMOVED ON (B)(6) 2018 DUE TO A LEAK AT THE HUB AREA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555240 ↗
• MalfunctionApr 26, 2018Hole In Material

  IT WAS REPORTED THAT FACILITY FOUND A HOLE IN THE EXTENSION LEG. NO PATIENT INJURY WAS REPORTED, PATIENT WAS A PEDIATRIC PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7466146 ↗
• MalfunctionApr 24, 2018Leak/Splash; Nonstandard Device

  IT WAS REPORTED THAT THE PROVENA PICC WAS REMOVED AND REPLACED DUE TO HUB LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7456345 ↗
• MalfunctionMar 22, 2018Crack; Fluid/Blood Leak

  IT WAS REPORTED BY THE FACILITY THAT THEY FOUND A LEAK DUE TO A CRACK NEAR THE HUB. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7362050 ↗
• MalfunctionFeb 28, 2018Leak/Splash

  IT WAS REPORTED THAT THE CATHETER WAS DISCOVERED TO BE LEAKING FROM THE EXTENSION LEG CATHETER HUB CONNECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7303159 ↗
• MalfunctionFeb 9, 2018Crack; Leak/Splash

  IT WAS REPORTED BY THE FACILITY THAT THEY FOUND A LEAK DUE TO A CRACK NEAR THE HUB. IT WAS STATED THAT THIS HAS OCCURRED WITH FOUR PATIENTS. NO PATIENT DETAILS AVAILABLE AT THIS TIME; DATE OF OCCURRENCE WAS NOT REPORTED. NO INJURY TO THE PATIENTS WERE REPORTED. THIS FILE IS FOR THE FOURTH OF THE FOUR EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261415 ↗
• MalfunctionFeb 9, 2018Crack; Leak/Splash

  IT WAS REPORTED BY THE FACILITY THAT THEY FOUND A LEAK DUE TO A CRACK NEAR THE HUB. IT WAS STATED THAT THIS HAS OCCURRED WITH FOUR PATIENTS. NO PATIENT DETAILS AVAILABLE AT THIS TIME; DATE OF OCCURRENCE WAS NOT REPORTED. NO INJURY TO THE PATIENTS WERE REPORTED. THIS FILE IS FOR THE THIRD OF THE FOUR EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261413 ↗
• MalfunctionFeb 9, 2018Crack; Leak/Splash

  IT WAS REPORTED BY THE FACILITY THAT THEY FOUND A LEAK DUE TO A CRACK NEAR THE HUB. IT WAS STATED THAT THIS HAS OCCURRED WITH FOUR PATIENTS. NO PATIENT DETAILS AVAILABLE AT THIS TIME; DATE OF OCCURRENCE WAS NOT REPORTED. NO INJURY TO THE PATIENTS WERE REPORTED. THIS FILE IS FOR THE FIRST OF THE FOUR EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261412 ↗
• MalfunctionFeb 9, 2018Crack; Leak/Splash

  IT WAS REPORTED BY THE FACILITY THAT THEY FOUND A LEAK DUE TO A CRACK NEAR THE HUB. IT WAS STATED THAT THIS HAS OCCURRED WITH FOUR PATIENTS. NO PATIENT DETAILS AVAILABLE AT THIS TIME; DATE OF OCCURRENCE WAS NOT REPORTED. NO INJURY TO THE PATIENTS WERE REPORTED. THIS FILE IS FOR THE SECOND OF THE FOUR EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7261411 ↗
• MalfunctionFeb 2, 2018Hole In Material

  THE FACILITY REPORTED TO THE SALES REP THAT DURING USE A HOLE WAS NOTED AT THE HUB AND EXTENSION LEG CONNECTION. THE LINE WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7238131 ↗
• MalfunctionFeb 1, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS DISCOVERED TO BE LEAKING FROM THE EXTENSION LEG CATHETER HUB CONNECTION. THIS FILE IS FOR THE SECOND OF TWO REPORTED EVENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7234185 ↗
• MalfunctionFeb 1, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS DISCOVERED TO BE LEAKING FROM THE EXTENSION LEG CATHETER HUB CONNECTION. THIS FILE IS FOR THE FIRST OF TWO REPORTED EVENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7234183 ↗
• MalfunctionJan 24, 2018Fluid/Blood Leak

  IT WAS REPORTED BY THE FACILITY THAT THE PATIENT HAD A PICC PLACED ON (B)(6) 2017. IT WAS STATED THAT APPROXIMATELY ONE MONTH LATER, WHILE UNDER HOME CARE, THE PICC BEGAN TO LEAK WHERE THE CATHETER INSERTED INTO THE HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7217250 ↗