International safety notice
Common name: (1) Implantable biventricular pacing pulse generator with defibrillation function (2) Implantable biventricular pacing pulse generator with defibrillation function (3) Automatic planter type fine mover (5) Implantable biventricular pacing pulse generator with defibrillation function (6) Implantable biventricular pacing pulse generator with defibrillation function (7) Automatic planter type fine mover (9) Implantable biventricular pacing pulse generator with defibrillation function Sales name: (1) Viva CRT-D series (2)Viva Quad CRT-D series (3)Evera ICD series (4)Evera MRI ICD series (5)Amplia MRI CRT-D series (6)Claria MRI CRT-D series (7)Visia AF MRI ICD series (8)Cobalt MRI ICD series (9)Cobalt MRI CRT-D series
Japan / PMDA Recalls · JPN · May 11, 2023
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | Common name: (1) Implantable biventricular pacing pulse generator with defibrillation function (2) Implantable biventricular pacing pulse generator with defibrillation function (3) Automatic planter type fine mover (5) Implantable biventricular pacing pulse generator with defibrillation function (6) Implantable biventricular pacing pulse generator with defibrillation function (7) Automatic planter type fine mover (9) Implantable biventricular pacing pulse generator with defibrillation function Sales name: (1) Viva CRT-D series (2)Viva Quad CRT-D series (3)Evera ICD series (4)Evera MRI ICD series (5)Amplia MRI CRT-D series (6)Claria MRI CRT-D series (7)Visia AF MRI ICD series (8)Cobalt MRI ICD series (9)Cobalt MRI CRT-D series |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | RSM620347S，RSM620348S，RSM620354S，RSM620356S，RSM620359S, RTC617785S，RTC617786S，RTC617787S，RTC617788S，RTC617789S, RPB607896S，RPB607899S，RPB607900S，RPB607901S，RPB607903S, RTH601962S，RTH601964S，RTH601970S，RTH601974S，RTH601979S, RTC626625S，RTC626628S，RTC626642S，RTC626651S，RTC626652S, RTC626185S，RTC626186S，RTC626188S，RTC626191S，RTC626192S, PGZ622666S，PGZ622668S，PGZ622669S，PGZ622671S，PGZ622672S, RSL602153S，RSL602154S，RSL602155S，RSL602156S，RSL602160S, PGZ636232S，PGZ636234S，PGZ636235S，PGZ636237S，PGZ636238S, RSC600124S，RSC600266S，RSC600439S，RSC600454S，RSC600456S, RSL601581S，RSL601590S，RSL601592S，RSL601593S，RSL601879S, PGZ636343S，PGZ636344S，PGZ636346S，PGZ636347S，PGZ636349S and 4454 more |
| Date | May 11, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1