CPI - DEL Caribe
FDA adverse event reports naming CPI - DEL Caribe as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CPI - DEL CARIBE.
- Total reports
- 64,619
- Deaths
- 615
- Injuries
- 47,774
- Malfunctions
- 16,218
Reports per year
805
3006
5607
8608
5,69409
7,13210
8,03811
5,75112
5,31213
5,20214
4,76415
6,17316
7,84717
8,49218
1923
Source: FDA adverse event reports by year received, 2005–2023. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Permanent Defibrillator ElectrodesNVY14,567
- Permanent Pacemaker ElectrodeDTB13,267
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN12,035
- Implantable Cardioverter Defibrillator (Non-Crt)LWS11,752
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP6,657
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX4,344
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK1,887
- Pacemaker Lead AdaptorDTD53
- Implantable Pacemaker Pulse-GeneratorDXY33
- Electrode, Pacing And Cardioversion, Temporary, EpicardialNHW23
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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