—#140276

Product

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

FDA product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P110042
Affected lot / code info: A019995 A020132 A020240

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

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: Distributed in the US to MA and PR.

Timeline

Recall initiated: 2015-09-17
Posted by FDA: 2015-11-06
Terminated: 2016-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140276. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.