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Terminated

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

FDA Recall Z-1178-2017 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLWS
Date Initiated2017-01-12
Date Terminated2018-08-09
Product Quantity4,500

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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