Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide

FDA device recall Z-0965-2013 · posted 2013-03-18 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

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.

Action taken

Consignees were sent a Boston Scientific "Important Medical Device Information" letter dated March 1, 2012. The letter was addressed to "Dear Doctor". The letter described the product involved in the recall, the problem and provided Recommendations/Actions. US customers may contact Technical Services for more information at 800-227-3422.

Root cause

Software design

Status

Terminated

Product code

LWS

Quantity affected

2090 (570 USA; 1520 OUS)

Distribution

Worldwide Distribution, USA including the states of AZ, CA, CO, DC, GA, IL, MD, MA, MN, NJ, NY, NC, OH, PA, SC, VA, WA and the countries of AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, G

Date initiated

2013-03-01

Date posted

2013-03-18

Date terminated

2013-05-23

Location

Saint Paul, MN