EMBLEM S-ICD Pulse Generator May Lose Heart Sensing for 24 Hours
Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential for temporary loss of critical sensing function. Risk-of-harm product where serious harm—inability to respond to life-threatening arrhythmias—is theoretically possible during a 24-hour sensing disablement window.
Plain-English summary
Boston Scientific Corporation is recalling 3,856 units of the EMBLEM S-ICD Pulse Generator Model A209, a subcutaneous implantable cardioverter defibrillator, worldwide. The S-ICD is an implanted device that monitors the heart's electrical activity and delivers therapy to correct dangerous heart rhythms.
A rare interaction between the S-ICD and the LATITUDE communicator device may cause the S-ICD's sensing function to become disabled for a 24-hour period. During this time, the device would be unable to detect and respond to dangerous heart rhythms that require treatment.
Patients with affected devices should contact their healthcare provider or Boston Scientific for guidance and management of this issue. Affected devices can be identified through specific product codes and LATITUDE system enrollment records.
The recalled product
- Product
- EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Hazard
- sensing-disablement
- arrhythmia-risk
- device-interaction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- GTIN: 00802526544101
- 00802526548406
- 00802526575105
- 00802526575112
- 00802526575129
- 00802526575136
- 00802526575143
- 00802526575167
- 00802526575181
- 00802526575204
- 00802526575211
- 00802526575228
- 00802526599002
- All EMBLEM S-ICDs enrolled in LATITUDE
Distribution
Distribution scope not specified by the agency.
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