FDA Device recall Z-2328-2018
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095,…
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095,… by St Jude Medical, citing the firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2328-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-16 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
Reason
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Identifiers
| code_info | Serial #: 833542 828254 839337 827033 830536 830473 828959 830498 827015 1018188 833598 833523 827104 840…Serial #: 833542 828254 839337 827033 830536 830473 828959 830498 827015 1018188 833598 833523 827104 840503 833586 1049882 833556 839049 833566 839074 827025 839035 839036 839029 830549 833812 833565 839018 833597 833626 839305 833511 830503 822331 833536 1018242 822358 1018196 1049628 1018227 833898 839030 1018251 828334 827066 822343 822323 791985 792101 822370 822355 822345 822341 822322 792090 822356 822361 792111 791982 791992 822328 792106 822362 792114 792113 822363 822346 827040 822326 792097 822329 792095 792112 791998 822335 822317 791977 827070 822338 792092 822347 792002 827097 822321 792087 791994 827109 827012 822354 792099 827088 791993 822334 1049636 827037 822332 1065676 833576 833823 833539 833862 833833 833561 831076 830523 833507 833568 833622 833880 833580 833789 833854 833569 833602 833824 833827 833629 833885 833630 833897 833856 833573 8336 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2328-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.