Z-1178-2017Class II

Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer

Name: Z-1178-2017 Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer
Creator: Boston Scientific Corporation
Published: 2017-01-12
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-01-12 / Terminated / root cause: software

FDA source

Boston Scientific Corporation began a recall of Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer on 2017-01-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1178-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-12
Posted: 2017-02-09
Terminated: 2018-08-09
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 4,500
Distribution: 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.
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1178-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1178-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-09

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)