PowerPICC 1174108D2Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741154836), received between Mar 20, 2021 and Jul 27, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Data Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 11, 2025Open, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Difficult or Delayed Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50021755 ↗
• MalfunctionNov 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT A HAIR WAS FOUND WRAPPED AROUND MATERIALS IN THE PICC KIT.KIT WAS TRASHED AND A NEW KIT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478179 ↗
• MalfunctionJun 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE PICC PLACED JUNE 6 AND REMOVED JUNE 9 DUE TO KINKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332170 ↗
• MalfunctionJun 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WE HAD A PATIENT THAT WAS DISCHARGED WITH A 4FR SL PROVENA AND WENT TO A SKILLED NURSING FACILITY. THE PICC WAS REMOVED AT THE FACILITY DUE TO LEAKING. THE PATIENT STATED THAT WHEN THE RN FLUSHED THE CATHETER, THE PICC "LEAKED FLUID" UNDER THE DRESSING. I CAN ONLY ASSUME THIS IS AT/AROUND THE HUB. THE INJECTION CAPS WERE APPARENTLY REPLACED, BUT SINCE IT WAS LEAKING UNDER THE DRESSING THIS DID NOT ALLEVIATE THE ISSUE. THE PICC WAS SUBSEQUENTLY REMOVED AND THE PATIENT WAS READMITTED TO THE HOSPITAL WHERE THE PICC WAS REPLACED. THERE ARE MANY UNKNOWNS AT THE POINT OF CARE WITH REGARD TO PICC CARE/MAINTENANCE AT THE SKILLED NURSING FACILITY. THE FACILITY USES THE SECURACATH COMPRESSION STYLE SECUREMENT DEVICE. THE PICC TEAM PLACED A BARD 4FR POWER PICC SINGLE LUMEN PICC ON (B)(6) 2025 FOR LONG TERM IV ANTIBIOTICS, NO COMPLICATIONS NOTED WITH PICC INSERTION AND WAS USED AT THE FACILITY WITH NO LEAKING NOTED. PATIENT WAS DISCHARGED TO SKILLED NURSING FACILITY ON (B)(6) 2025 WHERE SHE CONTINUED ON THE LONG TERM IV ANTIBIOTICS. PATIENT STATES THAT WHILE SHE WAS THERE, HER PICC LINE STARTED LEAKING (POSSIBLY AT THE HUB AREA) AS SHE STATED THE DRESSING WAS GETTING WET WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143963 ↗
• MalfunctionApr 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, "A HOLE WAS FOUND IN PICC AFTER ED NURSE REQUESTED, WE COME TO ASSESS THE PICC FOR NOT FLUSHING. ON ARRIVAL THE NURSE REPORTED THAT SHE WAS ABLE TO GET THE PICC TO FLUSH, NO BLOOD RETURN AND THE DRESSING WAS SATURATED. ON OUR ASSESSMENT, WE WERE ABLE TO FLUSH THE PICC WITH IMMEDIATE CLEAR FLUID WHICH WAS OBVIOUSLY THE SALINE FLUSH EXITING THE PICC INSERTION SITE. NO PAIN WAS REPORTED FORM THE PATIENT OR SWELLING TO THE ARM. PICC WAS REMOVED WITHOUT DIFFICULTY AND CAME OUT COMPLETELY INTACT AT 41CM. ONCE THE PICC WAS PULLED THE HOLE WAS DISCOVERED ON THE UNDERSIDE OF THE PICC AT AROUND THE 3CM MARK. NOTABLE SIGNS ON ASSESSMENT WERE THAT WE WERE ABLE TO RESTORE BLOOD FLOW POSITIONALLY AS WELL AS INCREASE/DECREASE THE AMOUNT OF FLUID COMING THROUGH FROM THE INSERTION SITE BY MOVING THE PICC LUMENS WHILE FLUSHING. THE PICC WAS PLACED BY OUR TEAM ON (B)(6) 2025. THE PATIENT WAS DISCHARGED AND THEN RETURNED TO THE ED. THERE WAS NO PATIENT INJURY FROM THIS EVENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753747 ↗
• MalfunctionMay 3, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED, PICC HUB DISCONNECTED FROM CATHETER COMPLETELY. LINE HAD TO BE REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239187 ↗
• MalfunctionMar 23, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT WHEN SETTING UP FOR PICC PLACEMENT, CLINICIAN NOTED THAT RUBBER STOPPER THAT 3CG GUIDEWIRE GOES THROUGH WAS NOTICEABLY SHORTER (SMALLER) THAN WHAT WAS PREVIOUSLY SEEN IN THE KIT. PICC WAS TRIMMED AND FLUSHED, AND CLINICIAN NOTED A DROP OR TWO OF SALINE COME OUT THROUGH STOPPER. THEY DIDN'T THINK IT WAS TOO BAD, AND PROCEEDED WITH INSERTING PICC LIKE NORMAL. WHILE INSERTING PICC, THEY FLUSHED A FEW TIMES WHILE ADVANCING AND NOTED DROPS OF SALINE COMING OUT THROUGH STOPPER, WHEN NOTED PICC WAS IN POSITION PER SHERLOCK, ASPIRATED TO ENSURE GOOD BLOOD FLOW AND NOTED AIR WAS COMING IN THROUGH RUBBER STOPPER. CLINICIAN STOPPED, AND ENSURED T-CONNECTION WAS TIGHT AND ATTEMPTED AGAIN, NOTICING SAME ISSUE. THEY DID NOT ATTEMPT TO FLUSH AS A "BUNCH OF AIR" HAD BEEN INTRODUCED, REMOVED T-CONNECTOR AND GUIDEWIRE AND WAS ABLE TO ASPIRATE AND FLUSH, THEN PLACED A NEEDLELESS CONNECTOR ONTO PORT WITHOUT FURTHER ISSUES. CUSTOMER REPORTS THE PICC WAS OTHERWISE INTACT, SECURED WITH STATLOCK AND A SECUREPORT IV DRESSING. PATIENT HAD PICC INSERTED FOR LONG-TERM ANTIBIOTICS AND SENT HOME. CUSTOMER STATES NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16607601 ↗
• MalfunctionMar 14, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT "THE COMPLAINT OF THE CUSTOMER WAS THAT THE RUBBER STOPPER AT THE END OF THE STYLET T-LOCK ASSEMBLY FOR PICC PLACEMENT IS LEAKING WHEREAS IT NEVER WAS BEFORE. HE ALSO STATED THAT IT LOOKED LIKE A NEW STYLET STOPPER." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539977 ↗
• MalfunctionMar 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT IR PLACED A NEW DEVICE ON 1/17/23 AND WHEN THEY TOOK THAT OUT AT (B)(6)2023 THE PICC WAS KINKED IN 2 PLACES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538245 ↗
• InjuryMar 26, 2021Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED "4 FRENCH SINGLE LUMEN PICC WIRE BROKE OFF INSIDE PATIENT WHEN INSERTING TODAY. PATIENT HAD TO BE TAKEN TO IR FOR SURGICAL RETRIEVAL." ADD INFO RCVD 03/08/2021: PLACEMENT INFO: LEFT BRACHIAL VEIN. WAS THERE PATIENT HARM REPORTED?: PATIENT REQUIRED EXTRACTION OF THE BROKEN DEVICE, BUT SIGNIFICANT HARM NOTED. WHAT THEY¿RE BEING TREATED FOR: ADMITTED FOR FALL.

  Patient problems: Foreign Body In Patient

  MAUDE report 11575530 ↗
• MalfunctionMar 26, 2021Data Problem; Data Problem

  IT WAS REPORTED "WHEN I WAS PUTTING THE PICCS, THE SHERLOCK DID DETECTED THE LINE TO A CERTAIN POINT AND THEN IT JUST STOPPED AND THE YELLOW CIRCLE TURNED INTO A GREEN SQUARE AND FROZE IN PLACE. AT ONE POINT IT ENDED AT THE TOP OF THE SCREEN (LIKE A PICC THAT MAY BE GOING UP THE NECK) AND THEN ONCE IT WAS MOVING DOWN LIKE IT WAS GOING TO THE RIGHT PLACE BUT THEN FROZE INTO A GREEN SQUARE. THE EKG CHANGED APPROPRIATELY WHEN I DID GET THE LINES IN THE RIGHT PLACES BUT WE WANTED TO SEE IF YOU HAD ANY IDEA WHAT IT WAS. I EVEN RECALIBRATED THE SHERLOCK AND FLUSHED THE LINE DURING PLACEMENT." WHAT THEY'RE BEING TREATED FOR: SMALL BOWEL OBSTRUCTION PATIENT RELEVANT HISTORY: TPN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575319 ↗
• MalfunctionMar 26, 2021Data Problem; Data Problem

  IT WAS REPORTED WHILE PLACING A PICC WITH SHERLOCK TECHNOLOGY, THE YELLOW CIRCLE TURNING INTO A GREEN SQUARE AND FROZE IN PLACE." IT WAS STATED THE SHERLOCK DID DETECTED THE LINE TO A CERTAIN POINT AND THEN IT JUST STOPPED AND THE YELLOW CIRCLE TURNED INTO A GREEN SQUARE AND FROZE IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575314 ↗
• MalfunctionMar 20, 2021Data Problem; Data Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "I WAS PUTTING THE PICC AND THE SHERLOCK DID DETECTED THE LINE TO A CERTAIN POINT AND THEN IT JUST STOPPED AND THE YELLOW CIRCLE TURNED INTO A GREEN SQUARE AND FROZE IN PLACE. AT ONE POINT IT ENDED AT THE TOP OF THE SCREEN (LIKE A PICC THAT MAY BE GOING UP THE NECK) AND THEN ONCE IT WAS MOVING DOWN LIKE IT WAS GOING TO THE RIGHT PLACE BUT THEN FROZE INTO A GREEN SQUARE. THE EKG CHANGED APPROPRIATELY WHEN I DID GET THE LINES IN THE RIGHT PLACES BUT WE WANTED TO SEE IF YOU HAD ANY IDEA WHAT IT WAS. I EVEN RECALIBRATED THE SHERLOCK AND FLUSHED THE LINE DURING PLACEMENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536699 ↗