PowerPICC Provena S1193108D2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741154874), received between Aug 31, 2022 and Sep 10, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718566 ↗
• MalfunctionSep 1, 2026Device Dislodged or Dislocated

  Patient problems: Electric Shock

  MAUDE report 50543388 ↗
• MalfunctionJul 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT 1 DAY AFTER PLACEMENT, THE IV TEAM RECEIVED A CONSULT TO ASSESS THE PICC DUE TO NOT FLUSHING OR DRAWING. RN WAS CONCERNED ON ASSESSMENT OF PICC SITE BECAUSE THERE WAS INDURATION AND REDNESS AROUND THE DRESSING SITE. PICC REMOVED AND FOUND THAT IT WAS KINKED AT THE 4CM MARK.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 22473369 ↗
• MalfunctionJun 24, 2025Flushing Problem

  SINGLE LUMEN PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] PLACED ON [REDACTED], XRAY REPORTS PICC IS IN SATISFACTORY POSITION. IV TEAM RECEIVES A CONSULT ON [REDACTED], THE NEXT DAY, TO ASSESS PICC DUE TO NOT FLUSHING OR DRAWING. XRAY RE-DID TO CONFIRM PLACEMENT BEFORE GIVING CATHFLO. XRAY REPORTS PICC TIP IS NO LONGER IN SATISFACTORY POSITION. PICC CATHETER CHANGED OUT TO NEW PICC CATHETER; XRAY REPORTS CATHETER TIP IS IN SATISFACTORY POSITION. IV TEAM RECEIVES A CONSULT ON [REDACTED], THE FOLLOWING DAY, TO ASSESS PICC DUE TO NOT FLUSHING OR DRAWING. RN WAS CONCERNED ON ASSESSMENT OF PICC SITE BECAUSE THERE WAS INDURATION AND REDNESS AROUND THE DRESSING SITE. PICC REMOVED AND FOUND THAT IT WAS KINKED AT THE 4 CM MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319290 ↗
• MalfunctionDec 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT INTRODUCER FAILURE ADDITIONAL INFORMATION RECEIVED 11/22/2024: IT WAS REPORTED THE INTRODUCER WAS PLACED OVER THE GUIDEWIRE AND THE VASCULAR ACCESS NURSE ATTEMPTED TO ADVANCE THE INTRODUCER INTO THE VESSEL BUT WAS UNABLE. A SMALL INCISION USING A SCALPEL WAS MADE NEXT TO THE GUIDEWIRE TO INCREASE THE OPENING THROUGH THE SKIN AND, AGAIN, THE INTRODUCER ACCESS WAS ATTEMPTED BUT FAILED. THE ASSISTING RN THEN APPLIED PROPER STERILE GARMENTS AND ATTEMPTED TO ADVANCE THE INTRODUCER BUT WAS UNABLE. A 2ND PICC KIT WAS OPENED AND THE INTRODUCER RETRIEVED. THIS NEW INTRODUCER WAS PLACED OVER THE GUIDE WIRE AND WAS ABLE TO BE ADVANCED INTO THE VESSEL WITHOUT CONCERN. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER DELAYS. UPON EXAMINATION, IT APPEARS THAT THE FAULTY INTRODUCER HAS AN ENLARGED "RING" AREA THAT ENCIRCLES THE COMPONENT. THE "RING" INCREASED THE SIZE OF THE INTRODUCER ENOUGH THAT IT CAUGHT ON THE VESSEL WALL WHICH WAS WHY IT WAS UNABLE TO BE ADVANCED. THERE WERE NO COMPLICATIONS WITH EXCEPTION OF THE EXTRA INCISION AND TIME THE PATIENT SPENT WITH THEIR ARM AT AN UNCOMFORTABLE POSITION. NO ADDITIONAL NEGATIVE OUTCOMES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924919 ↗
• MalfunctionJul 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE PICC WAS PLACED ON 5/24 AT ZERO CM WITHOUT DIFFICULTY. PATIENT WENT HOME WITH PICC AND DAUGHTER IS A NURSE. PICC HAD BEEN WORKING GREAT WITH NO DIFFICULTY FLUSHING. PATIENT CAME TO ER ON 6/22 FOR LEAKING PICC. WHEN THE PICC WAS PULLED THERE WAS A HOLE AT 4CM. NO SERIOUS PATIENT INJURY. PATIENT HAD TO HAVE ANOTHER VASCULAR ACCESS DEVICE PLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784747 ↗
• MalfunctionAug 31, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY TM " CUSTOMER IS EXPERIENCING ISSUE WITH THE 3F INTRODUCER. INTRODUCER BENDS AND KINKS UPON INSERTION, RESULTING IN UNNECESSARY SKIN NICK RESULTING IN NECESSARY BLEEDING. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331851 ↗