Xcela 45672Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M001456720), received between Mar 31, 2016 and Jul 9, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A DIRECTOR OF CARDIAC AND VASCULAR SERVICES REPORTED AN ISSUE WITH AN XCELA 5FDL-55CM IR-145 KIT. DURING PLACEMENT OF THE CATHETER, THE PEEL AWAY SHEATH BROKE AWAY FROM THE SHEATH HUB AS THE PICC WAS BEING ADVANCED OVER THE GUIDEWIRE. THE SHEATH BECAME LODGED IN THE PATIENT'S BODY BUT WAS ABLE TO BE RETRIEVED USING A SNARE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19701499 ↗
• MalfunctionDec 4, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A GUIDEWIRE FROM A XCELA 5FDL-55CM IR-145 KIT. DURING THE PROCEDURE, A 0.018 INCH GUIDE WIRE WAS INSERTED INTO THE BODY AND A PICC CATHETER WAS INSERTED. WHEN TRYING TO REMOVE THE GUIDEWIRE, IT DID NOT COME OUT, SO THEY PULLED ON THE GUIDE WIRE AND THE TIP OF THE GUIDEWIRE BROKE. A SECOND KIT WAS OPENED, AND THE 0.018 INCH GUIDE WIRE WAS INSERTED INTO THE BODY AND A PICC CATHETER WAS INSERTED. WHEN TRYING TO REMOVE THE GUIDE WIRE, IT WOULD NOT COME OUT. THEY REMOVED THE PICC CATHETER AND GUIDEWIRE AS ONE UNIT DUE TO CONCERNS ABOUT THE SAME SYMPTOMS AS ABOVE OCCURRING. IT WAS REPORTED THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256665 ↗
• MalfunctionJun 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, FOLLOWING PLACEMENT OF AN XCELA PICC DEVICE, THE CATHETER HAD TO BE REMOVED AND REPLACED BECAUSE OF A LEAK. 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 8682330 ↗
• MalfunctionMar 31, 2016Crack; Crack

  REPORT OF HUB DETACHING FROM AN INDWELLING PICC REQUIRING REMOVAL OF THE PICC. NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5538825 ↗