Xcela 45671Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M001456710), received between May 18, 2016 and Aug 19, 2019 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  1ST PICC IN DESCRIPTION BELOW: AS REPORTED: ON BOTH LINES THE HUB OF THE PURPLE LUMEN HAS CRACKED. INITIALLY I ASSUMED THAT THE NEEDLE FREE DEVICE MAY HAVE BEEN OVER-THREADED BUT THAT DID NOT APPEAR TO BE THE CASE FOR THE FIRST FAULTY LINE AND WAS CERTAINLY NOT THE CASE FOR THE SECOND. THE CASES HAPPENED ON DIFFERENT WARDS AND HAD DIFFERENT NEEDLE FREE DEVICES ATTACHED. HOWEVER BOTH WERE APPROPRIATE TO BE ATTACHED TO THE LINE. BOTH LINES WERE FROM THE SAME BATCH; PRODUCT CODE 45-671, LOT NUMBER 5430656. BOTH PATIENTS HAD TO HAVE LINES REMOVED AND CANNULATED FOR IV ACCESS. PATIENT B IS PARTICULARLY DIFFICULT FOR IV ACCESS AND THEREFORE REPEAT ATTEMPTS FOR CANNULATION CAUSED HIM DISCOMFORT. THE USED CATHETER HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8906005 ↗
• MalfunctionAug 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  2ND PICC IN DESCRIPTION BELOW: AS REPORTED: ON BOTH LINES THE HUB OF THE PURPLE LUMEN HAS CRACKED. INITIALLY I ASSUMED THAT THE NEEDLE FREE DEVICE MAY HAVE BEEN OVER-THREADED BUT THAT DID NOT APPEAR TO BE THE CASE FOR THE FIRST FAULTY LINE AND WAS CERTAINLY NOT THE CASE FOR THE SECOND. THE CASES HAPPENED ON DIFFERENT WARDS AND HAD DIFFERENT NEEDLE FREE DEVICES ATTACHED HOWEVER BOTH WERE APPROPRIATE TO BE ATTACHED TO THE LINE. BOTH LINES WERE FROM THE SAME BATCH; PRODUCT CODE 45-671, LOT NUMBER 5430656. BOTH PATIENTS HAD TO HAVE LINES REMOVED AND CANNULATED FOR IV ACCESS. PATIENT B IS PARTICULARLY DIFFICULT FOR IV ACCESS AND THEREFORE REPEAT ATTEMPTS FOR CANNULATION CAUSED HIM DISCOMFORT. THE USED CATHETER HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8906003 ↗
• InjuryAug 14, 2019Fracture; Fracture

  AS REPORTED: THE PEELAWAY SHEATH DID NOT BREAKAWAY CLEANLY, LEAVING A FRAGMENT INSIDE THE PATIENT, WHICH HAD TO BE RECOVERED BY THE PICC INSERTER. IT WAS LOGGED AS A SERIOUS INCIDENT ON THE HOSPITAL'S DATIX SYSTEM HOWEVER NO HARM CAUSED TO THE PATIENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8893021 ↗
• InjuryFeb 19, 2019Material Separation; Material Separation

  RECEIVED NOTIFICATION FROM (B)(6) OF AN EVENT IN THE (B)(6): " FAILED INITIAL ATTEMPT AT PICC LINE INSERTION IN ITU; AS THE GUIDEWIRE THAT CAME IN THE KIT BECAME STUCK, THE WINDING UNRAVELLED AND IT COULD NOT BE RETRIEVED. THE PATIENT WAS BROUGHT TO IRU TO COMPLETE THE PROCEDURE. THE WIRE WAS REMOVED IN ITS ENTIRETY UNDER FLUOROSCOPIC CONTROL. REPEAT PUNCTURE OF THE RIGHT BRACHIAL VEIN PERFORMED UNDER ULTRASOUND GUIDANCE. DIFFERENT GUIDEWIRE USED AND A NEW 5FR DOUBLE LUMEN PICC LINE WAS PLACED SATISFACTORILY. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NEED FOR MINOR ADDITIONAL INTERVENTION. ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER): THE PATIENT WAS BROUGHT TO IRU TO COMPLETE THE PROCEDURE. THE WIRE WAS REMOVED IN ITS ENTIRETY UNDER FLUOROSCOPIC CONTROL. REPEAT PUNCTURE OF THE RIGHT BRACHIAL VEIN PERFORMED UNDER ULTRASOUND GUIDANCE. DIFFERENT GUIDEWIRE USED AND A NEW 5FR DOUBLE LUMEN PICC LINE WAS PLACED SATISFACTORILY. IT HAS BEEN INDICATED THAT THE INITIALLY USED GUIDEWIRE HAS BEEN DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351947 ↗
• InjuryJan 14, 2019Material Separation; Material Separation

  RECEIVED NOTIFICATION FROM (B)(6) OF AN EVENT IN THE (B)(6): "GUIDEWIRE (PACKAGED WITH XCELA PICC) GOT STUCK 10-15CM FROM INSERTION SITE AND COULD NOT BE WITHDRAWN. CATHETER AND SHEATH USED TO ATEMPT TO DISLODGE BUT TIP BROKE IN PATIENT - THIS COULD NOT BE SNARED OR RETRIEVED ENDOVASCULARLY AND HAD TO BE LEFT IN SITU. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): PROLONGED PROCEDURE TO ATTEMPT TO RETRIEVE EVENTUALLY ABANDONED WITH FRAGMENT LEFT IN SITU. NO DIRECT HARM ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER): PATIENT INFORMED. VASCULAR SURGERY CONSULTED WHO FELT RISK BENEFIT WAS IN FAVOR IF LEAVING IN SITU." IT HAS BEEN INDICATED THAT PORTION OF THE GUIDEWIRE NOT LEFT IN SITU WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8244136 ↗
• MalfunctionOct 11, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED, THE EXTENSION TUBING OF AN INDWELLING PICC FRACTURED RESULTING IN LEAKING OF CHEMO LIQUID. THE DEVICE WAS REMOVED AND REPLACED. THE USED CATHETER WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6017457 ↗
• MalfunctionOct 11, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED, THE EXTENSION TUBING OF AN INDWELLING PICC FRACTURED RESULTING IN LEAKING OF CHEMO LIQUID. THE DEVICE WAS REMOVED AND REPLACED. THE USED CATHETER HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6017454 ↗
• MalfunctionMay 18, 2016Fracture; Fracture

  PICC, PLACED ON (B)(6) BEGAN TO LEAK AT THE LOCATION OF THE HUB AND THE EXTENSION LEG TUBING CONNECTION. IT WAS NOT STATED THAT THE PATIENT WAS ADVERSELY AFFECTED BY THE EVENT. THE USED DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5663126 ↗