Sorin Group Italia S.r.l. - CRM Facility
FDA adverse event reports naming Sorin Group Italia S.r.l. - CRM Facility as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SORIN GROUP ITALIA S.R.L. - CRM FACILITY.
- Total reports
- 5,092
- Deaths
- 51
- Injuries
- 1,482
- Malfunctions
- 3,559
Reports per year
54114
70115
78316
83417
97618
61619
35220
10621
9122
4323
1624
2225
1126
Source: FDA adverse event reports by year received, 2014–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Defibrillator, Implantable, Dual-ChamberMRM1,243
- Pulse Generator, Permanent, ImplantableNVZ1,129
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK670
- Programmer, PacemakerKRG554
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP523
- Permanent Pacemaker ElectrodeDTB394
- Pacemaker/Icd/Crt Non-Implanted ComponentsOSR206
- Implantable Pacemaker Pulse-GeneratorDXY187
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN71
- Implantable Cardioverter Defibrillator (Non-Crt)LWS63
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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