Xcela 45731Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H965457310), received between Nov 2, 2018 and Jan 30, 2019 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, INDWELLING XCELA PICC WHICH HAD BEEN IN PLACE FOR 2 DAYS, WAS REMOVED AND REPLACED DUE TO A DETACHED HUB. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8288458 ↗
• MalfunctionNov 2, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED VALVED XCELA PICC PLACED ON OCTOBER 4. CATHETER DESCRIBED AS BEING "SLUGGISH" WITH HEMOLYSIS SINCE INSERTION. TPA GIVEN MULTIPLE TIMES WITH NO AFFECT. REMOVED ON (B)(6). NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8034267 ↗
• MalfunctionNov 2, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED VALVED XCELA PICC PLACED ON OCTOBER 4. PATIENT WAS DISCHARGED TO HOME. BECAUSE OF OCCLUSION ISSUES, PICC WAS REMOVED (SOMETIME BETWEEN OCTOBER 6-OCTOBER 10, EXACT DATE NOT KNOWN). PATIENT BACK AT HOSPITAL ON OCTOBER 11 TO HAVE ANOTHER PICC PLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8034261 ↗
• InjuryNov 2, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED VALVED XCELA PICC PLACED ON (B)(6). "PAIN WITH FLUSHING THE NEXT DAY AND UNABLE TO DRAW BLOOD, LINE NOT BEING USED UNTIL DUPLEX (ULTRASOUND), DVT FOUND." LINE REMOVED ON (B)(6).

  Patient problems: Pain; Thrombosis

  MAUDE report 8034260 ↗
• MalfunctionNov 2, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED VALVED XCELA PICC PLACED ON OCTOBER 7. UNABLE TO DRAW BLOOD DURING INSERTION. REPLACED ON OCTOBER 8 WITH ANOTHER PICC. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8034259 ↗
• MalfunctionNov 2, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED VALVED XCELA PICC PLACED ON SEPT 17. REMOVED ON SEPT 24 DUE TO "PAIN WITH INFUSION, HEMOLYSIS/OCCLUSION." NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8034258 ↗