PowerPICC 1174108D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00801741155048), received between Sep 20, 2018 and Sep 23, 2026 — classified as 6 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (22 reports).

2 FDA recall records name this device's identifier, 2 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. May 21, 2026Open, 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 · FDA record ↗

2. 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 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Activation Problem

  It was reported SecureLoc Introducer Needle safety did not engage and green safety portion completely came off exposing the needle. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870553 ↗
• MalfunctionSep 10, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717385 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT CRACKED EXTENSION LEG. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953565 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED VIA MEDSUN THAT PATIENT SENT TO ED BY INFUSION CENTER FOR LEAKING PICC. ED EVALUATED AND FOUND PART OF LINE PULLED OUT WITH SMALL TEAR AT SKIN SITE. PICC LINE REMOVED AND A NEW PICC REPLACED ON OPPOSITE ARM. UNCLEAR IF TEAR PRE-EXISTING OR WHEN PULLED OUT PRIOR TO PATIENT ARRIVAL AT INFUSION CENTER. BASED ON WHAT IS KNOWN, NO HARM TO THE PATIENT FROM PICC WITH TEAR AT ENTRY SITE. DAMAGED PICC WAS INSERTED PRIOR TO THIS VISIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442667 ↗
• InjuryDec 19, 2025Material Frayed; Material Frayed

  IT WAS REPORTED BY RN DURING PICC INSERTION PROCEDURE THE GUIDEWIRE FRACTURED/"CAMP APART" IN THE PATIENTS ARM WHILE TRYING TO RETRACT IT FROM THE NEEDLE. "I USED VERY LITTLE FORCE, IT JUST SHREDDED, AND A PIECE OF IT IS IN THE PATIENT'S ARM". THE RETAINED PIECE WAS NOT REMOVED. NO KNOWN HARM WAS CAUSED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23850244 ↗
• MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT HAD A SL PICC PLACED ON (B)(6) 2025 FOR HOME IV THERAPY. RETURNED TO THE ED 12/6/25 DUE TO LEAKING. LINE WAS FLUSHED TO FIND SALINE LEAKING WITH FLUSH. LINE WAS RETRACTED 4 CM OUT TO FIND THE AREA OF FRACTURE. PICC WAS REMOVED DUE TO FRACTURE AND MIDLINE PLACED TO COMPLETE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849654 ↗
• MalfunctionAug 13, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN TRYING TO INSERT THE INTRODUCER, THE INTRODUCER WILL NOT PENETRATE THE VESSEL. IT BENDS AND BECOMES USELESS. THE 5FR MICRO INTRODUCER WAS USED TO COMPLETE THE PICC INSERTION. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793713 ↗
• MalfunctionAug 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN TRYING TO INSERT THE INTRODUCER, THE INTRODUCER WILL NOT PENETRATE THE VESSEL. IT BENDS AND BECOMES USELESS. THE 5FR MICRO INTRODUCER WAS USED TO COMPLETE THE PICC INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790045 ↗
• MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH THAT HAD A 4FR SINGLE LUMEN PICC LINE THAT HAD A SPLIT IN THE CATHETER AROUND THE 6CM MARK. PATIENT HAD IT PLACED AND RETURNED TO THE HOSPITAL WITH COMPLAINTS OF PICC LEAKING AND DIFFICULTY FLUSHING, UPON ASSESSMENT PICC WAS DIFFICULT TO FLUSH AND BEGAN TO CREATE A SITE OF EDEMA AND LEAKING AT THE INSERTION SITE. PICC WAS REMOVED AND REPLACED ON OPPOSITE ARM.

  Patient problems: Infiltration into Tissue; Swelling/ Edema

  MAUDE report 22652592 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, FRACTURED PICC LINE WAS CALLED BY NURSING STAFF TO EVALUATE PATIENT'S RIGHT ARM PICC FOR OCCLUSION AND NOT ABLE TO FLUSH. TEAM PLACED A 10ML SYRINGE TO FLUSH PICC AND NOTED A SWISH SOUND WHILE ATTEMPTING TO FLUSH THE LINE, ONLY 2ML WERE INSTILLED BUT NOTED FLUID COMING OUT OF THE INSERTION SITE WHILE ATTEMPTING TO FLUSH. DRESSING WAS REMOVED TO EVALUATE SITE EVEN CLOSER WITHOUT A DRESSING IN PLACE AND A SECOND ATTEMPT WAS MADE TO FLUSH WITH AN ADDITIONAL 2ML OF FLUSH USING A 10ML SYRINGE. IMMEDIATELY NOTICED THE FLUSH WAS COMING BACK OUT THROUGH THE INSERTION SITE. THE RIGHT ARM PICC WAS DISCONTINUED AND CLOSELY EVALUATE A PARTIAL FRACTURE IN THE CATHETER AT THE 6CM MARK. THE ENTIRE 44CM OF PICC WAS REMOVED THE SAME AS UPON INITIAL INSERTION. IN THE MEANTIME, PATIENT HAS 4 MORE DAYS OF IV ANTIBIOTICS SO I PLACED A LEFT UPPER ARM BASILIC MIDLINE FOR CONTINUED IV THERAPY WITHOUT INTERRUPTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555133 ↗
• MalfunctionJul 17, 2025Material Deformation; Material Deformation

  THE CUSTOMER REPORTED KINKING OF A SINGLE LUMEN PICC INSERTED IN THE BASILIC VEIN. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538666 ↗
• MalfunctionJul 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT A PICC LINE WAS INSERTED ON (B)(6) 2025, TO THE BRACHIAL. ON (B)(6) 2025 THE CATHETER KINKED PICC X-RAYS WERE PREFORMED AND PICC WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519533 ↗
• MalfunctionJul 15, 2025Difficult to Flush; Obstruction of Flow; Positioning Problem

  OUR VASCULAR ACCESS TEAM ATTEMPTED TO FLUSH A "BARD POWERPICC" [PERIPHERALLY INSERTED CENTRAL CATHETER] THAT HAD BEEN PLACED 24 HOURS EARLIER, WITH NO LUCK. THE RN WAS NOT ABLE TO FLUSH THE PICC OR HAVE BLOOD RETURN ONCE ACCESSING THE PICC LINE. PATIENT HAD A RIGHT HUMERUS X-RAY, WHICH SHOWED THE PICC CATHETER DOUBLE LOOPED ON ITSELF AT THE PATIENT'S MID HUMERUS. PATIENT UNDERWENT A PICC UNDERWIRE EXCHANGE IN INTERVENTIONAL RADIOLOGY WITHOUT ISSUES, WHICH FIXED THE DOUBLE LOOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505813 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED 6/3 WE HAD A PICC THAT WE DREW BACK AND NOTED AIR GO INTO THE SYRINGE WHILE WE WERE CHECKING FOR BLOOD RETURN. I IMMEDIATELY TOOK PICC OUT AND PUT INTRODUCER CANNULA BACK IN AND WE OBTAINED A NEW PICC. WE RE-EXAMINED THE LINE AND I HAD THE CLAMP ON THE TUBING ATTACHED TO PICC TO SHOW THE LEAK I FOUND WHEN I EVALUATED THE LINE AFTER TAKING IT OUT OF THE PATIENT TO SEE WHY WHEN I PULED BACK THERE WAS AIR IN THE SYRINGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338378 ↗
• MalfunctionMay 5, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PICCS ARE MIS-MARKED ON THE MEASUREMENTS. MISSING ABOUT 10CM HAS LED TO MULTIPLE INACCURATE PICC TRIMS. I WAS TRAINING A BRAND NEW PICC PLACER AND THE FIRST PICC SHE USED WE NOTICED THE LACK OF MARKINGS AND STOPPED THE PROCEDURE AND GOT A NEW KIT. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965180 ↗
• MalfunctionMay 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY CUSTOMER THAT PICC IS MIS-MARKED ON THE MEASUREMENTS. MISSING ABOUT 10CM HAS LED TO MULTIPLE MAL-POSITIONED PICCS. CLINICIAN HAD INCONGRUENCY BETWEEN 3CG AND X-RAY AND HAD A 10CM TOO SHORT PICC. CLINICIAN REPEATED THE PROCEDURE AND FEELS THAT THE MARKINGS MUST HAVE BEEN WRONG AS HE MADE MULTIPLE ADJUSTMENTS AND NOTHING SEEMED TO MAKE SENSE. THE MALPOSITION WAS FOUND AFTER THE FACT (3CG WAS INITIALLY CORRECT-BUT X-RAY SHOWED SIGNIFICANT MALPOSITION. OF NOTE PATIENT HAD METAL SHRAPNEL IN CHEST). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965179 ↗
• MalfunctionApr 2, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THE INSERTER NOTICED THAT THE GREEN PIECE ON THE SECURELOC NEEDLE WAS SEPARATED UPON OPENING THE PICC KIT DURING THE MIDDLE OF THE STERILE PROCEDURE. THERE WAS NO INJURY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752939 ↗
• MalfunctionFeb 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE CATHETER HAD A HOLE IN IT AND NEEDED TO BE REMOVED. ADDITIONAL INFORMATION: IT WAS REPORTED THIS HOLE WAS FOUND AROUND THE 5TH CM WHICH WAS INSIDE THE PATIENT. LINE HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469037 ↗
• MalfunctionFeb 21, 2025Activation Problem; Activation Problem

  IT WAS REPORTED VIA MEDSUN THAT DURING PICC PLACEMENT, THE NEEDLE WITHIN THE BARD PICC KIT WITH THE GREEN SAFETY DEVICE FAILED TO ENGAGE AS DESIGNED. THE SAFETY MECHANISM, INTENDED TO SLIDE UP THE NEEDLE TO THE SKIN, DID NOT ACTIVATE AND DETACHED COMPLETELY. NO INJURIES OCCURRED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432942 ↗
• MalfunctionFeb 6, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THE INTRODUCER NEEDLE IN TWO PICC KITS WOULD NOT SAFETY COMPLETELY AND SEPARATED FROM THE NEEDLE. THE PICC PLACER WAS PAYING CLOSE ATTENTION AND WAS ABLE TO ADJUST, SO THERE WAS NO INJURY TO PATIENTS OR STAFF. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21328643 ↗
• MalfunctionJan 31, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THE SECURELOCK NEEDLE DID NOT PROPERLY FUNCTION. IT CAME OFF THE NEEDLE COMPLETELY WHEN ATTEMPTED TO SLIDE THE NEEDLE ON THE TRAY TO RETRACT THE GREEN CAP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287607 ↗
• MalfunctionJan 31, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER, SECURELOCK NEEDLE DID NOT PROPERLY FUNCTION. IT CAME OFF COMPLETELY WHEN ATTEMPTED TO SLIDE THE NEEDLE ON THE TRAY TO RETRACT THE GREEN CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285259 ↗
• MalfunctionNov 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT ONCOLOGY PATIENT CAME IN FOR LAB DRAWS BUT NURSES WERE UNABLE TO DRAW OUT OF PATIENTS PICC LINE. CALLED FOR VAT CONSULT WHO WAS ALSO UNSUCCESSFUL. PATIENT WAS ALSO COMPLAINING OF PAIN SO PICC WAS REMOVED. UPON REMOVAL THE PICC WAS FRACTURED AROUND THE 5CM MARK. ADDITIONAL INFORMATION RECEIVED 10/24/2024: IT WAS REPORTED THERE WERE NO NEGATIVE CLINICAL IMPACT ON THE PATIENT, OTHER THAN LOSING CENTRAL ACCESS WHILE STILL NEEDED FOR OUTPATIENT CHEMO TREATMENTS. NO INJURY OR ADVERSE EVENT TO PATIENT OR HEALTHCARE WORKER.

  Patient problems: Pain

  MAUDE report 20727619 ↗
• MalfunctionNov 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONCOLOGY PATIENT THAT HAD A PICC LINE WITH A FRACTURE AROUND THE 5CM MARK. NO NEGATIVE PATIENT IMPACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727350 ↗
• InjuryNov 1, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT ON THE AFTERNOON OF 10/8 WHILE PLACING A SINGLE LUMEN PICC APPROXIMATELY 2 CM OF THE STYLET BROKE OFF INTO THE PATIENT AND WAS RETRIEVED BY IR. PATIENT HAD TO BE SENT TO INTERVENTIONAL RADIOLOGY TO HAVE THE BROKEN WIRE RETRIEVED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 20586850 ↗