PowerPICC Provena S9395108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741112911), received between Nov 19, 2020 and Mar 21, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE "POWERPICC SOLO PROVENA TRIPLE LUMEN PICCS ARE KINKING." THEY STATE THIS IS NOT HAPPENING ON THE NON-SOLO TRIPLE LUMEN PROVENA PICCS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587959 ↗
• MalfunctionJan 29, 2021Failure to Infuse; Failure to Infuse; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED "CUSTOMER SHARED THAT THE SOLO VALVES ON TRIPLE LUMEN PICC STOPPED WORKING AFTER A FEW HOURS OF PLACING IT. IT WORKED WELL AT INSERTION AND AFTER INITIAL INSERTION HOWEVER ONCE IT WAS ATTEMPTED TO BE ACCESSED HOURS LATER IT DID NOT WORK. PATIENT HAD AN X-RAY AND THEY WERE INSTRUCTED TO PULL IT BACK. DESPITE DOING SO IT DID NOT WORK. CUSTOMER HAS THE PICC AND WILL SEND IT IN FOR EVALUATION" ADDITIONAL INFORMATION RECEIVED 01/11/2020: "A COUPLE HOURS AFTER PLACEMENT THE NURSE CALLED THE VAT TEAM SAYING IT WOULD NO FLUSH OR DRAW. TEAM WENT AND EVALUATED, DRESSING CHANGE COMPLETED. NO KINKS OR ISSUES NOTED. PULLED LINE BACK A COUPLE CM, LINE CONTINUED NOT TO WORK. X-RAY ORDERED; NO ISSUES FOUND. REPLACED LINE."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11251978 ↗
• MalfunctionDec 11, 2020Break; Physical Resistance/Sticking

  IT WAS REPORTED AFTER CUSTOMER GAINED ACCESS WITH NEEDLE, THEY WERE ABLE TO THREAD THE WIRE AND THEN INTRODUCER WITH NO ISSUES, HOWEVER THEY WENT TO THREAD PICC AND MET RESISTANCE. NURSE MANIPULATED THE PICC BACK AND FORTH A FEW TIMES TO SEE IF THE PICC WOULD PASS RESISTANCE BUT IT DID NOT. AFTER NOT BEING ABLE TO THREAD THE PICC HE THEN REMOVED THE DEVICE AND WHEN TO FLUSH THE LINE WITH THE STY-LET STILL IN DEVICE, AT THAT POINT HE SAW A PIECE OF THE STY-LET COME OUT OF THE PICC THAT HAD BROKEN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10993396 ↗
• InjuryDec 11, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT A FOREIGN OBJECT FOUND IN PT. ON CHEST X-RAY. INTERVENTIONAL RADIOLOGIST CONSULTED AND REMOVED THE OBJECT AND SENT IT TO PATHOLOGY. APPEARS TO BE A SMALL PIECE OF WIRE. PATIENT HAD A BARD PICC LINE INSERTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10993251 ↗
• InjuryNov 19, 2020Break

  IT WAS REPORTED: "WE HAVE HAD A PIECE OF A GUIDEWIRE THAT BROKE OFF IN A PATIENT" "X-RAY SHOWED AN OBJECT IN THE CHEST. IR REMOVED IT ON (B)(6) 2020. UPON REMOVAL, THE OBJECT APPEARS TO BE THE STYLET OF PICC LINE INSERTED ON (B)(6) 2020. "

  Patient problems: Foreign Body In Patient

  MAUDE report 10870873 ↗