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Versicon® JTSB350DRecalls & reported problems

Joimax GmbH · Single-Use Tubing Set for joimax® Versicon® Spine Pump JISP3000 · Class 2

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 04250337105640), received between Jul 12, 2018 and Jul 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

  • Fluid/Blood Leak1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionJul 12, 2018Fluid/Blood Leak; Fluid/Blood Leak

    JOIMAX BECAME AWARE OF A MAUDE REPORT FILED BY A HEALTHCARE FACILITY ALLEGING THAT DURING PREPARATION FOR SURGERY THE VERSICON TUBING SET LEAKED. THE FACILITY REPORTS THAT THE LEAKING TUBING WAS REMOVED FROM THE FIELD, DISCARDED, AND REPLACED WITH A NEW TUBING SET WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF INJURY. BECAUSE THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS THE INVESTIGATION WAS INCONCLUSIVE AS TO WHETHER THE EVENT WAS ATTRIBUTED TO DEVICE MALFUNCTION OR USE ERROR.

    Patient problems: No Patient Involvement

    MAUDE report 7683295 ↗

Other Lavage, Jet devices

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