Z-0232-2016Class II

Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation...

Name: Z-0232-2016 Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation...
Creator: Boston Scientific Corporation
Published: 2015-09-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2015-09-17 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy on 2015-09-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0232-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-17
Posted: 2015-11-06
Terminated: 2016-03-08
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 3
Distribution: Distributed in the US to MA and PR.
Product codes and lots: A019995 A020132 A020240

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0232-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0232-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)