Agency classClass IIOur severity:Severe FDA (Devices)·Z-3039-2017·Announced 2017-08-23

Boston Scientific Recalls SQ-RX 1010 Pulse Generators Due to Memory Corruption

Boston Scientific is recalling approximately 12,450 SQ-RX 1010 Pulse Generators because memory corruption may cause the device to deliver an atypical amount of energy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a life-sustaining medical device that could deliver atypical energy, meeting the criteria for a Severe rating.

Plain-English summary

Boston Scientific Corporation is recalling approximately 12,450 SQ-RX 1010 Pulse Generators. These devices are part of the S-ICD system, which is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

The recall is being conducted because the device can deliver an atypical amount of energy due to memory corruption inside the device. The affected units were distributed nationwide in the United States, including Puerto Rico, the U.S. Virgin Islands, and Guam, as well as in foreign countries including Canada.

Patients with these devices should contact their healthcare provider for further instructions. The recall number is Z-3039-2017.

The recalled product

Product: SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or…
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Implantable Cardiac Device
Hazard: electrical-malfunction
memory-corruption
Affected units: 12,450

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 (1)

All serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Boston Scientific Corporation

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Same hazard · electrical malfunction