Livewire™ 402152Recalls & reported problems
St. Jude Medical Cardiovascular Division · Ablation Catheter · Class 3
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734200257), received between Nov 26, 2020 and Nov 10, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical Shorting” (2 reports).
1 other recall cover devices cleared under the same FDA submission (P960016); 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.
Reports received per month
Most reported problems
Device problems
- Electrical Shorting2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2023Electrical Shorting; Electrical Shorting
THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT THAT WAS NOTED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18115040 ↗MalfunctionNov 26, 2020Electrical Shorting; Electrical Shorting
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS, CONFIRMING A SHORT CIRCUIT IDENTIFIED WITHIN THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10908821 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P960016. One submission often covers many models, so check the product and lot details in each record.
- Z-2313-2008 · Jun 5, 2008 · TerminatedThe St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, M
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.