Recall Z-2075-2019 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
St Jude Medical Inc.
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
| Date | Aug 2, 2019 (initiated Jun 20, 2019) |
| Status | Terminated |
| Reason | Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices. |
| Root cause | Process control |
| Action | On 06/20/19, Sales Representatives visited impacted customer accounts to provide talking points that included the reason for recall and to retrieve affected devices. On 06/21/19, hand-delivery of Urgent Medical Device Recall Notices, to physicians supporting implanted patients, commenced. Customers were informed that there is no available option to verify the vulnerability status for implanted devices. Device explant and replacement are recommended. Customers were advised to: 1) Review the device model and serial numbers in the appendix of this letter to identify the impacted patients and ret |
| Quantity | 42 |
| Distribution | Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.