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Xcela 45712Recalls & reported problems

Navilyst Medical, Inc. · Xcela PICC with PASV Valve Technology - 4Fx55cm Catheter MST-70 Kit · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965457120), received between Aug 3, 2016 and Aug 3, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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.

Most reported problems

Device problems

  • Detachment Of Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 3, 2016Detachment Of Device Component; Detachment Of Device Component

    AS REPORTED, DURING A PROCEDURE TO INSERT A PICC DEVICE BOTH HANDLES DETACHED FROM A PEELABLE SHEATH. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE USED DEVICE HAS BEEN RETURNED FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5842957 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

All Catheter,intravascular,therapeutic,long-term greater than 30 days devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.