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St. Jude Medical, Cardiac Rhythm Management Division FDA Recalls
8 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Merlin 2 PCS MER37000 programmer Model MER3400 softwareClass IIJun 17, 2022The Merlin" 2 PCS model MER3700 is a portable, dedicated pro |
| Merlin PCS 3650 programmer Model 3330 softwareClass IIJun 17, 2022There is a potential for programmer software (Merlin PCS) an |
| Merlin.net model MN5000 SoftwareClass IIJun 17, 2022The Merlin" 2 PCS model MER3700 is a portable, dedicated pro |
| Merlin 2 PCS MER3700 programmer Model MER3400 softwareClass IIMar 10, 2022Due to a programmer software anomaly under very specific cir |
| Merlin PCS 3650 programmer Model 3330 softwareClass IIMar 10, 2022Due to a programmer software anomaly under very specific cir |
| Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500QClass IIMar 10, 2022Bluetooth malfunction impacting Gallant devices post-implant |
| Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500QClass IIMar 10, 2022Bluetooth malfunction impacting Gallant devices post-implant |
| Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500QClass IIMar 10, 2022Bluetooth malfunction impacting Gallant devices post-implant |