ST. Jude Medical, Costa Rica Ltda
FDA adverse event reports naming ST. Jude Medical, Costa Rica Ltda as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ST. JUDE MEDICAL, COSTA RICA LTDA.
- Total reports
- 1,789
- Deaths
- 96
- Injuries
- 1,210
- Malfunctions
- 483
Reports per year
213
2414
9015
7816
17317
29818
35519
27020
16021
27122
1123
4324
1425
Source: FDA adverse event reports by year received, 2013–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Heart-Valve, Non-Allograft TissueLWR684
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationOAE384
- Introducer, CatheterDYB188
- TrocarDRC140
- Transducer, Pressure, Catheter TipDXO113
- Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF89
- Wire, Guide, CatheterDQX68
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD50
- Aortic Valve, Prosthesis, Percutaneously DeliveredNPT24
- Catheter, Ultrasound, IntravascularOBJ19
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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