PowerPICC® Catheters 1275108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00801741034558), received between May 25, 2016 and Jul 14, 2026 — classified as 15 injuries, 100 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (50 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT FEW INTRODUCERS THAT HAVE BEEN REALLY DIFFICULT TO INTRODUCE, CAUSING US TO OPEN A WHOLE NEW KIT. ADDITIONAL INFORMATION RECEIVED 19-MAY-2026: THE INSERTIONS WERE NOT DIFFICULT UNTIL THE PICC NURSE GOT TO THE INTRODUCER PART. AT THAT POINT, UPON INTRODUCTION THERE WAS SOME DIFFICULTY AND THEN A LIP THAT DEVELOPED MAKING IT IMPOSSIBLE TO CONTINUE EVEN WITH FURTHER DERMATOTOMY. THIS RESULTED IN ANOTHER KIT HAVING TO BE OPENED. NO FURTHER DETAILS PROVIDED. 06/30/2026 IT WAS FOUND DURING INVESTIGATION THAT REVEALED A BEND ON THE MICROINTRODUCER SHAFT AND DAMAGE AT THE SHEATH TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25815342 ↗
• MalfunctionFeb 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THEY WERE INSTRUCTED TO RETRACT THE PICC BASED ON THE CHEST X-RAY FINDING. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422841 ↗
• MalfunctionFeb 23, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PATIENT HAS HAD THEIR PICC IN PLACE SINCE (B)(6) 2025. WE WERE INSTRUCTED TO RETRACT THE PICC BASED ON CXR FINDING. WHEN CLINICIAN RETRACTED THE PICC, THERE WERE NO MARKINGS ON THE PICC. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422231 ↗
• MalfunctionJan 8, 2026Contamination /Decontamination Problem; Material Deformation

  ADDITIONAL INFORMATION RECEIVED 1/5/2026: THE PATIENT REQUIRED PICC REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003008 ↗
• MalfunctionJan 7, 2026Product Quality Problem

  IT WAS REPORTED PICC WASN'T WORKING SO NURSE REMOVED IT AND SAW ONE OF THE PIGTAILS WERE STRETCHED OUT LONGER THAN THE OTHER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996367 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 5F DL PICC LEAKING AT JUNCTION BETWEEN PICC AND END CAP/CONNECTOR. LINE PULLED FROM PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709773 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 5F DL PICC LEAKING AT JUNCTION BETWEEN PICC AND END CAP/CONNECTOR. LINE PULLED FROM PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709335 ↗
• MalfunctionApr 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY MEDWATCH THAT THE POWER PERIPHERALLY INSERTED CENTRAL CATHETER WITH SHERLOCK POSITIONING SYSTEM HAD A HAIR IN IT. NOT USED ON THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769819 ↗
• MalfunctionMar 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PROVIDER WAS ABOUT PLACE A DUAL LUMEN PICC ON A PATIENT IN ICU. WHEN THEY OPENED THE KIT, THERE WAS A HAIR PRESENT. PICC KIT WAS NOT USED ON THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636057 ↗
• MalfunctionFeb 6, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THE SAFETY NEEDLE IN PICC KIT MALFUNCTIONED. THE SAFETY NEEDLES WERE TO BE USED THE GREEN SAFETY CAP FELL OFF WHEN THE PICC NURSES PICKED THE NEEDLES UP FROM THE KIT. THERE WAS NO HARM TO PATIENT OR STAFF. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322041 ↗
• MalfunctionFeb 5, 2025Activation Problem; Activation Problem

  IT WAS REPORTED A MALFUNCTION WITH THE SAFETY NEEDLE THAT COMES WITH THE PICC KITS, THE SAFETY PORTION OF THE NEEDLE JUST FELL OFF. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318818 ↗
• InjuryJan 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A GUIDEWIRE THAT IS REMOVED WITH A KNOT AT THE END THAT NEEDED THE SURGICAL TEAM TO REMOVE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21146226 ↗
• MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC WAS PLACED ON (B)(6) 2024 MEASURING AT 42 CM WITH 3CM VISIBLE WITH SECUREMENT DEVICE USED TO KEEP THE PICC IN PLACE. ON (B)(6) 2024 THE PICC WAS FOUND TO BE LEAKING AT THE 0-1 CM MARK. PICC WAS REMOVED, WITH NEW PICC PLACED ON (B)(6) 2024. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120803 ↗
• InjuryJan 9, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER, UPON REMOVAL OF PICC IT SNAPPED OUT AT 7 CM INTO TWO PIECES SUBCUTANEOUSLY AND HAD TO BE RETRIEVED IN IR.

  Patient problems: Foreign Body In Patient

  MAUDE report 21114099 ↗
• MalfunctionDec 12, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT ACCESS NEEDLE FROM PICC KIT WILL NOT SAFETY, HAS HAPPENED A COUPLE OF TIMES APPARENTLY WITH THE GREEN NEEDLE. DANGER FOR HCP DUE TO NON-SAFETY NEEDLE. NO OTHER INFORMATION PROVIDED, AT THIS TIME. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES ALL BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921528 ↗
• MalfunctionDec 4, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THE GREEN SAFETY ON THE INTRODUCER NEEDLE IN THE KIT HAS FALLEN OFF, NOT MAKING THE DEVICE A SAFETY DEVICE. EVENT OCCURRED AT AN UNKNOWN DATE IN THE MONTH OF OCTOBER. NO PATIENT HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847810 ↗
• MalfunctionNov 22, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT PICC INSERTION OF DOUBLE LUMEN. THE TIP OF THE 3CG WIRE WAS INSPECTED AND THE COPPER TIP FOUND TO BE BROKEN OFF. PICC RN ASPIRATED APPROXIMATELY 8-10CC OF BLOOD FROM EACH LUMEN AND SQUIRTED BLOOD INTO STERILE TRAY. MISSING TIP WAS LOCATED IN THE BLOOD THAT WAS ASPIRATED. OBTAINED NEW 3CG WIRE FROM A DIFFERENT KIT (4FR SINGLE LUMEN KIT) TO COMPLETE THE PROCEDURE AND VERIFY PICC LOCATION. PICC PLACEMENT CONFIRMED. PATIENT REMAINED STABLE THROUGHOUT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192529 ↗
• MalfunctionSep 7, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A 5FRENCH DL3CG PPICC PLACED ON A PATIENT EARLIER IN THE WEEK AND THEY GOT A CALL FROM ONE OF THE BEDSIDE NURSES SAYING WHILE THEY WERE TURNING THE PATIENT IT ¿BROKE¿. SANDY DESCRIBES IT THAT IT LOOKS LIKE IT RIPPED AT THE HUB ON THE EXTENSION SET. THE BEDSIDE TEAM DIDN¿T SAVE IT WHEN THEY PULLED IT. ADDITIONAL INFORMATION RECEIVED ON 29 AUGUST 2023: THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. THERE WERE NO PIECES RETAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699513 ↗
• MalfunctionJan 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "POWER-PICC CATHETER LEAKING THROUGH PURPLE LUMEN-VALVE JOINT. CLINICIAN NOTICED AFTER PLACEMENT, PATIENT STILL HAS THE CATHETER BUT UNABLE TO USE PURPLE LUMEN FOR MEDICATION ADMINISTRATION." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16243972 ↗
• MalfunctionOct 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "STAT RN WAS ASKED TO COME ASSESS A LEAKING DL PICC LINE. PICC LINE WAS LEAKING TPN, ALTHOUGH HAD BLOOD RETURN. PICC VERIFIED AT CORRECT POSITION WHEN PLACED. LEAKING SEEMS TO BE DUE TO A CRACK IN LINE. PATIENT NEEDED IR TO REWIRE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15682498 ↗
• MalfunctionOct 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING SEEMS TO BE DUE TO A CRACK IN LINE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15682426 ↗
• InjuryOct 19, 2022Component Incompatible; Defective Component; Component Incompatible; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT "PICC LINE INSERTION WITH PROPER PICC NEEDLE START, FLASH BACK RECEIVED. WHILE ADVANCING WIRE, WIRE COULD NOT PASS NEEDLE. THEY ATTEMPTED TO PULL BACK ON WIRE TO REMOVE. ENTIRE NEEDLE NEEDED TO BE REMOVED CAUSING SECOND ATTEMPT. NEW KIT OPENED ONTO STERILE FIELD. ATTEMPTED SECOND START, WIRE CAUSED POTENTIAL VEIN DAMAGE. SECOND ATTEMPT COULD NOT BE COMPLETED AT THIS TIME."

  Patient problems: Perforation of Vessels

  MAUDE report 15633357 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH: "PLACED A DOUBLE LUMEN PICC ON A POST HEART TRANSPLANT PATIENT, ALMOST AT THE END OF PROCEDURE, WHILE CHECKING FOR BLOOD RETURN PURPLE PORT WAS DRAWING AIR. CHANGED NEEDLELESS CONNECTOR 3 TIMES AND STILL DRAWING AIR. WE HAD TO REWIRE THE DEFECTIVE PICC THAT TOOK US LONGER TO PLACE." WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PICC LINE PLACEMENT POST HEART TRANSPLANT WHAT PROBLEM DID THE USER HAVE?: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15548076 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH: "PLACED A DOUBLE LUMEN PICC ON A POST HEART TRANSPLANT PATIENT, ALMOST AT THE END OF PROCEDURE, WHILE CHECKING FOR BLOOD RETURN PURPLE PORT WAS DRAWING AIR. CHANGED NEEDLELESS CONNECTOR 3 TIMES AND STILL DRAWING AIR. WE HAD TO REWIRE THE DEFECTIVE PICC THAT TOOK US LONGER TO PLACE." WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PICC LINE PLACEMENT POST HEART TRANSPLANT WHAT PROBLEM DID THE USER HAVE?: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15548075 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH: "PLACED A DOUBLE LUMEN PICC ON A POST HEART TRANSPLANT PATIENT, ALMOST AT THE END OF PROCEDURE, WHILE CHECKING FOR BLOOD RETURN PURPLE PORT WAS DRAWING AIR. CHANGED NEEDLELESS CONNECTOR 3 TIMES AND STILL DRAWING AIR. WE HAD TO REWIRE THE DEFECTIVE PICC THAT TOOK US LONGER TO PLACE." WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PICC LINE PLACEMENT POST HEART TRANSPLANT WHAT PROBLEM DID THE USER HAVE?: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15548017 ↗