Recall Z-2543-2019 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific Corporation
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
| Date | Aug 21, 2019 |
| Status | Open, Classified |
| Reason | Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion. |
| Root cause | Component design/selection |
| Action | Boston Scientific began notifying physicians of the recall on about 08/21/2019, via "URGENT: MEDICAL DEVICE ADVISORY" letter. The physicians associated with the affected devices were provide a letter with a list of affected model/serial numbers for patients which they have implanted and/or followed or sent to their center. The letter informed physicians of the potential for accelerated battery depletion on select active worldwide EMBLEM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs). Physicians were instructed to follow up with affected units implanted in patients by enroll a |
| Quantity | 404 devices |
| Distribution | Nationwide distribution to Alabama, Arizona, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Or |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.