EMBLEM MRI S-ICD Pulse Generator Model A219 recallZ-2442-2023 · Boston Scientific Corporation · initiated Jul 11, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
FDA root cause category: Software design
What the company is doing
Boston Scientific disseminated an Important Medical Device Information notice to the physician or healthcare professional consignees beginning on 07/11/2023 by hand delivery using their sales representatives, The notices explain the problem, risk, and recommend the following: Please distribute this letter to all HCPs who manage follow-ups of S-ICD patients. Perform the next scheduled device check in-person using a Model 3300 LATITUDE programmer with Model 3877 v1.04 software or Model 3200 EMBLEM programmer with Model 2877 v4.10 software to address any potential for this rare S-ICD behavior. Up-to-date product performance information and a device lookup tool are available within our Product Performance Resource Center at www.bostonscientific.com/ppr. If you have additional questions regarding this information or need to report an adverse event, please contact your Boston Scientific representative or Technical Services, and your local regulatory authority, as applicable. On 08/16/2023 Boston Scientific mailed the letter to EMBLEM S-ICD implanting and/or following physicians/clinics of record. On 09/15/2023, Boston Scientific began distributing a letter dated September 2023 (with the original communication enclosed), to new implanting and following physicians/clinics of record since the August 2023 communication.
Recall details
- Recall number
- Z-2442-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 11, 2023
- Posted by the FDA
- Aug 22, 2023
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 41,411 units
- Product code
- LWS
- FDA submissions
- P110042
- Distribution
- Worldwide
Product description
EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
Code information (models, lots, serial numbers)
GTIN: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; All EMBLEM S-ICDs enrolled in LATITUDE
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
Other devices under the same FDA submission
9 devices cleared under P110042 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- EMBLEM™ S-ICD 3401Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)5 deaths1,039 reports
- SQ-RX® PULSE GENERATOR 1010Cameron Health, Inc. · Implantable cardioverter defibrillator (non-CRT)3 deaths596 reports
- EMBLEM™ S-ICD 3401Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 death532 reports
- The Q-TRAK™ Subcutaneous Electrode 3400Cameron Health, Inc. · Implantable cardioverter defibrillator (non-CRT)2 deaths394 reports
- SQ-RX® PULSE GENERATOR 1010Cameron Health, Inc. · Implantable cardioverter defibrillator (non-CRT)3 deaths262 reports
- EMBLEM™ S-ICD Electrode Delivery System 4712Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 death7 reports
- EMBLEM™ S-ICD Programmer 3200Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92760).
- Z-2441-2023 · Open, ClassifiedEMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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