Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
Class I - DangerousWhat Should You Do?
- Check if you have this product: A019995 A020132 A020240
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
Product Codes/Lot Numbers:
A019995 A020132 A020240
Distribution:
Distributed in: US, MA, PR
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0232-2016
Related Recalls
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Boston Scientific
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia