SQ-RX Pulse Generator (2018-11-05)

Starting date:

November 5, 2018

Posting date:

November 30, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68472

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  Reason
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  Affected products

Affected products

SQ-RX Pulse Generator

Reason

Potential for a shortened replacement interval after a Charge Time (CT) / Battery Depletion (BD) alert has occurred or after the battery status reaches Elective Replacement Indicator (ERI) in the first-generation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system's SQ-Rx model 1010 Pulse Generator (PG). Boston scientific have observed an elevated rate of these PGs experiencing latent battery malfunctions resulting in accelerated battery depletion and a shortened replacement interval.

Affected products