Recall Z-0965-2013— Boston Scientific CRM Corp
Class II · Terminated
Class II FDA medical device recall by Boston Scientific CRM Corp, initiated 2013-03-01, terminated 2013-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.. Reason: An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application..
- Recalling firm
- Boston Scientific CRM Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-01
- Terminated
- 2013-05-23
- Firm location
- Saint Paul, MN, United States
Product description
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
Reason for recall
An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.
Data sourced from openFDA. This site is unofficial and independent of the FDA.