PowerPICC Provena S1274108D2Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741154843), received between Apr 17, 2019 and Jun 17, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Defective Component” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Unable to Obtain Readings

  IT WAS REPORTED THAT TEAM WAS PLACING A PICC AND TRACKING THE SHERLOCK LOLLIPOP. AS THE PICC AND THE LOLLIPOP DROPPED INTO THE SVC THE INTERNAL 3CG WAVE FORM DISAPPEARS FROM THE SCREEN. IF THEY FLUSH REALLY HEARD THE INTERNAL WAVEFORM COMES BACK FOR A COUPLE BEATS AND THEN DISAPPEARS. THEY WERE ABLE TO REPEATEDLY GET THE WAVEFORM TO REAPPEAR WITH A HARD FLUSH BUT COULD NOT GET A STEADY READING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533376 ↗
• MalfunctionJun 17, 2026Unable to Obtain Readings

  IT WAS REPORTED THAT TEAM WAS PLACING A PICC AND TRACKING THE SHERLOCK LOLLIPOP. AS THE PICC AND THE LOLLIPOP DROPPED INTO THE SVC THE INTERNAL 3CG WAVE FORM DISAPPEARS FROM THE SCREEN. IF THEY FLUSH REALLY HEARD THE INTERNAL WAVEFORM COMES BACK FOR A COUPLE BEATS AND THEN DISAPPEARS. THEY WERE ABLE TO REPEATEDLY GET THE WAVEFORM TO REAPPEAR WITH A HARD FLUSH BUT COULD NOT GET A STEADY READING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533368 ↗
• InjuryDec 30, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT GUIDEWIRE FROM A PROVENA PICC FRAYED OFF IN THE PATIENTS ARM AND REMAINING FRAGMENTS ARE IN PATIENT TISSUE. ADDITIONAL INFORMATION RECEIVED 20-DEC-2024; IT WAS REPORTED BY THE CUSTOMER THE PATIENT HAD RETAINED FRAGMENTS OF THE GUIDEWIRE LEFT IN THEIR ARM. SURGICAL REMOVAL OF THE RETAINED FRAGMENTS FROM THE PATIENT¿S TISSUE WAS REQUIRED. ACCORDING TO PRE- AND POST-IMAGING, STAFF BELIEVE THAT ALL FRAGMENTS WERE ABLE TO BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21036550 ↗
• MalfunctionJun 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE PLACED THIS MORNING AT APPROXIMATELY 0900. NO COMPLICATIONS DURING PLACEMENT. BEDSIDE RN (REGISTERED NURSE) CONTACTED NVAT (NURSING VASCULAR ACCESS TEAM) DUE TO THE RED LUMEN LEAKING IVF (INTRAVENOUS FLUIDS) NEAR WHERE THE CAP IS ATTACHED- SHE CHANGED CAP TO SEE IF THAT FIXED THE PROBLEM, WHICH IT DID NOT. NVAT ASSESSED AT BEDSIDE: CAP CHANGED, VARIOUS FLUSHING AND CAP LOOSENING/TIGHTENING PERFORMED TO TROUBLESHOOT THIS ISSUE. ULTIMATELY, NONE WERE SUCCESSFUL, AND DECISION WAS MADE TO EXCHANGE LINE OVER WIRE. THE PATIENT HAD THE PICC LINE REPLACED THE SAME DAY D/T THE LEAKING LUMEN. THE PICC LINE HAS BEEN DISPOSED OF BY THE PICC TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19626152 ↗
• MalfunctionApr 14, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  IT WAS REPORTED BY THE CUSTOMER THAT MULTIPLE SAME LOT NUMBERS OCCLUDING WITHIN SHORT TIME AFTER PLACEMENT. USING ADDITIONAL KITS BECAUSE OF LEAKING LUMENS. NO OTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED MULTIPLE EVENTS HOWEVER THE EXACT NUMBER OF EVENTS WAS NOT PROVIDED TO BD VASCULAR ACCESS DEVICES FIELD ASSURANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748278 ↗
• MalfunctionApr 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "PICC OCCLUDED WITHIN SHORT TIME AFTER PLACEMENT. USED ADDITIONAL KIT BECAUSE OF LEAKING LUMENS." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731838 ↗
• MalfunctionApr 4, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER, "WE EXPERIENCED LEAKING FROM AROUND THE WIRE AS FLUSH WAS DONE THROUGH THE SIDE PORT EVEN AFTER THE HUB CONNECTION WAS CHECKED. THE FLUID IS COMING DIRECTLY FROM THE WIRE PUNCTURE THROUGH THE RUBBER INJECTION SITE. THERE WAS NO REPORTED SAFETY CONCERN FOR CLINICIAN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16676329 ↗
• MalfunctionApr 1, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER WE EXPERIENCED LEAKING FROM AROUND THE WIRE AS FLUSH WAS DONE THROUGH THE SIDE PORT EVEN AFTER THE HUB CONNECTION WAS CHECKED. THE FLUID IS COMING DIRECTLY FROM THE WIRE PUNCTURE THROUGH THE RUBBER INJECTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660736 ↗
• MalfunctionMar 28, 2023Defective Component; Defective Component

  IT WAS REPORTED "WE EXPERIENCED LEAKING FROM AROUND THE WIRE AS FLUSH WAS DONE THROUGH THE SIDE PORT EVEN AFTER THE HUB CONNECTION WAS CHECKED. THE FLUID IS COMING DIRECTLY FROM THE WIRE PUNCTURE THROUGH THE RUBBER INJECTION SITE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632531 ↗
• MalfunctionFeb 22, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER THAT "HAIR WAS LOCATED IN PICC TRAY OUTSIDE OF WRAP. TRAY WAS NOT USED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420717 ↗
• MalfunctionDec 17, 2021Defective Component; Material Deformation; Defective Component; Material Deformation

  IT WAS REPORTED "STYLET IS BENT/BROKEN AT THE END OF PICC KIT". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025268 ↗
• MalfunctionDec 17, 2021Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED "STYLET IS BENT/BROKEN AT THE END OF PICC KIT". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025266 ↗
• MalfunctionDec 14, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "STYLET LOOKS BENT CLOSE TO THE TIP." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004339 ↗
• MalfunctionOct 7, 2021Material Frayed; Material Frayed

  IT WAS REPORTED 4 FR DL PROVENA PICC WIRE BREAKING DURING INSERTION PROCESS. HAD TO GET CXR BECAUSE COULD NOT CONFIRM PLACEMENT WITH THAT WIRE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594177 ↗
• MalfunctionNov 30, 2020Material Twisted/Bent

  IT WAS REPORTED "PROVENA 4 FR DL POWER PICC KINKED IN PATIENTS ARM". THE PICC WAS SECURED WITH A STATLOCK. ADDITIONAL INFO. RECEIVED 11/11/2020: WAS THERE PATIENT HARM REPORTED? YES INCIDENT REPORT COMPLETED; PATIENT ASYMPTOTIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10919948 ↗
• MalfunctionNov 26, 2020Material Deformation; Material Twisted/Bent; Material Deformation

  IT WAS REPORTED THE PROVENA CATHETER WAS REMOVED DUE TO A MECHANICAL OCCLUSION. THE CATHETER WAS KINKED TWICE, AT THE 2CM AND 4CM MARK. PATIENT HAD AN ARM CIRCUMFERENCE OF 43CM, THE PICC KINKED IN THE ADIPOSE TISSUE. IT STARTED HAVING ISSUES THE VERY NEXT DAY AFTER INSERTION. THEY TRIED CATHFLO WITHOUT SUCCESS. THE PICC WAS IN AT THE HUB AND 0 MARK.

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

  MAUDE report 10908713 ↗
• MalfunctionOct 30, 2020Deformation Due to Compressive Stress

  IT WAS REPORTED 4FR DUAL LUMEN PICC KINKED TWICE "DOUBLE Z" IN AN OBESE PATIENT OUTSIDE OF THE REVERSE TAPER. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10764549 ↗
• MalfunctionApr 17, 2019Flushing Problem; Leak/Splash; Suction Failure

  IT WAS REPORTED, "PLACED A LUA PICC IN THE BASILIC VEIN WITHOUT DIFFICULTY ON (B)(6) 2019, AT 1205. THE PICC WAS CUT TO 46 CM WITH 3 CM LEFT EXTERNAL. IT WAS REPORTED TO ME THE NEXT MORNING THAT THEY HAD DIFFICULTY ASPIRATING BLOOD FROM THE PICC AND THAT THEY COULDN'T FLUSH IT, OR IT WAS DIFFICULTY TO FLUSH AND THAT IT HAD SIGNIFICANT LEAKAGE OF SEROSANGUINOUS FLUID FROM THE INSERTION SITE WHILE THEY WERE INFUSING FLUIDS. THE NIGHT SHIFT RN STOPPED USING THE PICC AFTER IT WAS NOTED TO BE LEAKING AND AN EXTERNAL JUGULAR IV HAD TO BE PLACED, DUE TO THIS PT'S VERY POOR PERIPHERAL VASCULATURE. I WENT IN TO ASSESS THE PICC AND THE DRESSING WAS COMPLETELY SATURATED AND SOMEONE HAD SIMPLY LEFT THE DRESSING IN PLACE AND STUCK A WAD OF 4X4S AT THE BASE OF THE DRESSING AND TAPED IT INTO PLACE. WHEN I REMOVED THE WAD OF 4X4S, IT WAS TOTALLY SATURATED. THERE WAS NO SWELLING NOTED AT THE SITE, NO BRUISING OR REDNESS. PT DID C/O SOME "TENDERNESS" AT THE SITE AFTER PLACEMENT AND STATED HE HAD THE SAME "TENDERNESS" WHEN I WAS EVALUATING THE SITE. I REMOVED THE DRESSING AND DID A STERILE DRESSING CHANGE AND NOTED PICC TO BE OUT 4 CM AT THIS POINT. I WAS ABLE TO ASPIRATE BLOOD FROM BOTH PORTS AND FL

  Patient problems: Failure of Implant

  MAUDE report 8524954 ↗