PowerPICC Provena CK000992Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741213304), received between Jul 7, 2022 and Nov 5, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT COURSE BLACK HAIR WAS FOUND IN BETWEEN THE DRAPE AND THE TRAY IN PICC INSERTION KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479173 ↗
• MalfunctionMar 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER THEY OPENED A STERILE PICC KIT AND FOUND A HAIR IN THE KIT AND DID NOT USE THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585859 ↗
• InjuryDec 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER "HAS INFORMED ME THAT THEY HAVE HAD 3 INSTANCES OVER THE PAST FEW WEEKS OF 3CG CONFIRMING GOOD PICC LOCATION, AND THEN UPON X-RAY IT APPEARS A FEW CENTIMETERS OFF FROM THE LOWER SVC. THE 3 PATIENTS HAVE HAD ECTOPIES AND RUNS OF V TACH WITHIN A DAY AFTER PICC PLACEMENT, WHEN THE 3CG READINGS/P-WAVES LOOKED REALLY GOOD DURING PLACEMENT." THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: Arrhythmia

  MAUDE report 15929188 ↗
• InjuryDec 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER "HAS INFORMED ME THAT THEY HAVE HAD 3 INSTANCES OVER THE PAST FEW WEEKS OF 3CG CONFIRMING GOOD PICC LOCATION, AND THEN UPON X-RAY IT APPEARS A FEW CENTIMETERS OFF FROM THE LOWER SVC. THE 3 PATIENTS HAVE HAD ECTOPIES AND RUNS OF V TACH WITHIN A DAY AFTER PICC PLACEMENT, WHEN THE 3CG READINGS/P-WAVES LOOKED REALLY GOOD DURING PLACEMENT." THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: Arrhythmia

  MAUDE report 15929112 ↗
• InjuryDec 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER "HAS INFORMED ME THAT THEY HAVE HAD 3 INSTANCES OVER THE PAST FEW WEEKS OF 3CG CONFIRMING GOOD PICC LOCATION, AND THEN UPON X-RAY IT APPEARS A FEW CENTIMETERS OFF FROM THE LOWER SVC. THE 3 PATIENTS HAVE HAD ECTOPIES AND RUNS OF V TACH WITHIN A DAY AFTER PICC PLACEMENT, WHEN THE 3CG READINGS/P-WAVES LOOKED REALLY GOOD DURING PLACEMENT." THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: Arrhythmia

  MAUDE report 15929067 ↗
• InjuryNov 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER LINE IS TOO DEEP (CLEARLY ON CXR AND WITH PATENCY ISSUES BECAUSE OF) WITH NO NEGATIVE DEFLECTIONS ON 3CG PRINT OUT AND VICE-VERSA NEGATIVE DEFLECTION ON WELL PLACED PICC TIP. THE PATIENT HAD RUNS OF VTACH BECAUSE THE LINE WAS INTO THE ATRIUM. THIS PICC WAS REMOVED DURING AN OVER THE WIRE EXCHANGE TO DECREASE CATHETER LENGTH. LINES HAD EXCELLENT 3CG WAVEFORMS TO CONFIRM TIP LOCATION.

  Patient problems: Arrhythmia

  MAUDE report 15782480 ↗
• MalfunctionNov 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PICC THAT WAS PLACED ON SATURDAY, 3CG LOOKS GOOD. ON SUNDAY THERE WAS OCCLUSION ISSUES SO A CXR WAS ORDERED AND IT CLEARLY SHOWS PICC TIP VERY MUCH IN THE RIGHT ATRIUM. THE LINE WAS PULLED BACK 4CM AS RECOMMENDED BY RADIOLOGIST AND POST REPOSITIONING CXR SHOWED TIP IN CAVO-ATRIAL JUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755037 ↗
• MalfunctionJul 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED " RIGHT BRACHIAL DOUBLE LUMEN PICC PLACED (B)(6) 2022. UNABLE TO ASPIRATE BOTH LUMENS. DRESSING REMOVED UPON PALPATION AT INSERTION SITE CATHETER KINKING WAS FELT UNDER THE SKIN. PULLED 2 CM OUT FROM INSERTION SITE FOR A TOTAL EXTERNAL LENGTH OF 5 CM. BOTH LUMENS OF PICC WERE NOW FLUSHING WITHOUT RESISTANCE WITH BRISK BLOOD RETURN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085402 ↗
• MalfunctionJul 7, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER PICC LINE KINKING 1-2 DAYS AFTER INSERTION, RESULTING IN OCCLUSION ALARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14952083 ↗