Boston Scientific Corporation: Medical Device Recall in 2017 - (Recall #: Z-1178-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 12, 2017

Date Posted: February 15, 2017

Recall Number: Z-1178-2017

Event ID: 76323

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.

Status: Terminated

Product Quantity: 4,500

Code Information:

All serial numbers.

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.

Voluntary or Mandated:

Voluntary: Firm initiated