—#152779

Product

Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.

FDA product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P110042
Affected lot / code info: All serial numbers.

Why it was recalled

There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behavior occurring when the LATITUDE Patient Management System communicates with an S-ICD in an ambulatory setting.

Root cause (FDA determination)

Software design

Action the firm took

Boston Scientific sent an "Important Medical Device Information" letter dated on January 12, 2017. The letter was addressed to "Dear Doctor". The letter included information on the Description and Clinical Implications, Rate of Occurrence, Recommendations, Affected Programmer & Additional Information. For additional questions regarding this communication or to report clinical events, contact your Boston Scientific representative or Technical Services at 1 800-227-3422.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: Worldwide Distribution - USA ( nationwide) including PR and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY., and to the countries of :Canada, Austria, Belgium, Czech Republic, Denmark, Finland, France, French Polynesia, Guadeloupe, Monaco, New Caledonia, Reunion, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Australia, China, Egypt, Hong Kong, India, Iran, Japan, Jordan, Kuwait, Lebanon, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Thailand, Tunisia, Turkey, United Arab Emirates, Argentina, Bermuda and Brazil.

Timeline

Recall initiated: 2017-01-12
Terminated: 2018-08-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152779. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.