Skip to content

Reflexion HD™ D402864Recalls & reported problems

St. Jude Medical, Inc. · Bi-Directional High Density Mapping Catheter · 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 05414734217262), received between Nov 14, 2022 and Nov 14, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical Shorting” (1 report).

1 other recall cover devices cleared under the same FDA submission (K080179); they may or may not involve this specific model.

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

  • Electrical Shorting1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 14, 2022Electrical Shorting; Electrical Shorting

    THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT FOUND DURING ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15794898 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080179. One submission often covers many models, so check the product and lot details in each record.

  • Z-1291-2011 · Oct 27, 2010 · Terminated
    02.122.590, 90mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and

Other CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices

All CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING devices →

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