Boston Scientific Corporation Recall 90985
Description: EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Boston Scientific Corporation Recall 90985 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0151-2023 |
| Event ID | 90985 |
| Event Description | EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and United Kingdom. |
| Quantity | 7 devices |
| Recall Reason | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. |
| Device Classification | 20221109 |
| Device Code Info | UPN: 00802526548406; Serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297. |
| Center Classification Date | 20221031 |
| Recall Initiation Date | 20220930 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Visit |
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