Recall Z-1512-2020 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific Corporation
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
| Date | Mar 3, 2020 (initiated Feb 12, 2020) |
| Status | Terminated |
| Reason | Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall by letter on 12/12/2020. The letter explained the error and requested the consignee segregate the units for removal. The firm will provide another model of programmer to be used in the interim. |
| Quantity | 1 device |
| Distribution | US Nationwide distribution in the states of NC, TN, and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.