Boston Scientific SQ-RX Model 1010 subcutaneous pulse… recallZ-0232-2016 · Boston Scientific Corporation · initiated Sep 17, 2015
Class II Terminated All recalls posted in November 2015
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
Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once established no further difficulty is expecte
FDA root cause category: Process design
What the company is doing
One consignee was contacted via a Boston Scientific "Medical Device Retrieval" letter dated September 17, 2015. The letter was addressed to Hospital Administrator. The letter described the problem and the product involved in the recall. Informed consignee that their local Boston Scientific sales representative will be retrieving the product form their inventory. For questions they can contact their local sales representative or Boston Scientific Technical service at 1-800-227-3422. A second Boston Scientific "Important Medical Device Information" letter dated October 2015 was hand delivered to physicians starting on 10/15/2015. The letter described the problem and provided information on Clinical Considerations, Affected Population, Recommendations and Further Information. For questions they can contact their Boston scientific representative or the Americas Technical service at 1-800-227-3422.
Recall details
- Recall number
- Z-0232-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 17, 2015
- Posted by the FDA
- Nov 6, 2015
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 3
- Product code
- LWS
- FDA submissions
- P110042
- Distribution
- Distributed in the US to MA and PR.
Product description
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
Code information (models, lots, serial numbers)
A019995 A020132 A020240
Other devices under the same FDA submission
10 devices cleared under P110042 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- 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
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 18, 2026. Text above is shown as published by the FDA.
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