SynCardia Recalls Companion External Batteries Due to Thermal Event Risk
SynCardia Systems is recalling Companion External Batteries used with the Companion 2 Driver System because they may be at risk of thermal events or physical damage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of thermal events, melting, and burning, which constitutes a significant injury risk.
Plain-English summary
SynCardia Systems Inc. is recalling the Companion External Battery, Part Number 293001-001, which is a component of the Companion 2 Driver System. The recall involves 81 units that were distributed worldwide, including nationwide in the United States.
The batteries are being recalled because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring, and/or burning. The Companion 2 Driver System, used with the temporary Total Artificial Heart (TAH-t), is indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
The source text does not specify the exact actions consumers or healthcare providers should take, such as whether to stop using the device or contact the manufacturer for a replacement. Users of these specific serial numbers should refer to the official FDA recall notice for detailed instructions.
The recalled product
- Product
- Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to…
- Manufacturer
- SynCardia Systems Inc.
- Category
- Medical Device — Cardiac Support
- Affected units
- 81
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · SynCardia Systems Inc.
See all →- CriticalSynCardia Freedom Driver System Recalled for Potential Silent Failure
FDA (Devices) · 2016-12-14
- CriticalSynCardia Recalls Freedom Drivers for Potential Drive Mechanism Failure
FDA (Devices) · 2015-09-23
Same hazard · thermal event
See all →- High
- HighUltrasound Systems Recalled for Loose Power Connections Causing Thermal Hazard
FDA (Devices) · 2024-10-30
- CriticalMcGrath Mac Video Laryngoscope battery depletion may cause thermal event and explosion
FDA (Devices) · 2024-08-28
- SevereMcGRATH MAC EMS Video Laryngoscope Battery Management System Recall
FDA (Devices) · 2024-08-28
- HighTabloCart power cord connector may overheat in hemodialysis system
FDA (Devices) · 2024-06-26
Similar recalls
- CriticalSynCardia Recalls Freedom Drivers for Potential Drive Mechanism Failure
FDA (Devices) · 2015-09-23
- CriticalSynCardia Freedom Driver System Recalled for Potential Silent Failure
FDA (Devices) · 2016-12-14
- HighSynCardia Artificial Hearts Recalled for Unapproved Epoxy Resin
FDA (Devices) · 2023-11-01
- HighHeartWare HVAD Pump Implant Kit Battery Recall for Support Issues
FDA (Devices) · 2014-05-21
- SevereHeartware Medtronic HVAD System Recalled for Transient Electrical Interruptions
FDA (Devices) · 2018-06-06
- CriticalHeartware Ventricular Assist System Battery Recall for Premature Depletion
FDA (Devices) · 2016-07-20