Sorin Group Italia S.r.l
86, VIA STATALE 12 NORD, MIRANDOLA Modena, IT
Registered product codes
16 product codes
Recent MDR events
6,162 on file
- INSPIREMay 26, 2026Malfunction25277465
- ISOLINEApr 30, 2026Malfunction1000165971-2026-00271
- ISOLINEApr 17, 2026Malfunction1000165971-2026-00241
- STELIDApr 14, 2026Malfunction1000165971-2026-00229
- ELAPASSApr 9, 2026Injury1000165971-2026-00303
- PARADYM 2Apr 2, 2026Malfunction1000165971-2026-00205
- ISOLINEMar 30, 2026Malfunction1000165971-2026-00530
- ISOLINEMar 30, 2026Malfunction1000165971-2026-00544
- INSPIRE 7F M N/SFeb 19, 2026Malfunction9680841-2026-900006
- ELAPASSJan 30, 2026Malfunction1000165971-2026-00040
Recalls
6 on file
- TerminatedJan 22, 2014
Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.
View FDA record ↗ - TerminatedUnknown
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
View FDA record ↗ - TerminatedUnknown
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
View FDA record ↗ - TerminatedUnknown
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
View FDA record ↗ - TerminatedUnknown
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
View FDA record ↗ - TerminatedUnknown
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
View FDA record ↗
Compliance history
Matched by FEI 3005426550.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.