FDA Device recall Z-2322-2018
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407 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-2322-2018 |
| 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
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906
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 #: 709757 709778 706480 706481 711414 688003 685487 709738 683775 711424 713640 691372 686757 6868…Serial #: 709757 709778 706480 706481 711414 688003 685487 709738 683775 711424 713640 691372 686757 686823 691331 685597 681345 691377 685532 687976 687986 691387 685495 711497 686842 691364 691327 686773 685441 691399 691375 686795 691311 686796 685451 691404 691303 685433 705343 691395 705293 705282 685591 706504 686768 691393 705366 691351 711499 713626 819121 711452 829224 713644 809004 808988 711481 711404 711475 711496 713600 713631 713621 713645 713606 791104 711439 713603 711456 711491 713609 808993 761908 713614 711478 786501 791113 711420 713613 713618 711405 761899 763493 763501 763500 791095 791103 786454 796199 796214 796197 796198 796202 791111 761981 761969 761973 832166 832164 832168 791128 791123 791125 791091 791124 791093 791153 791139 791158 791127 791145 786495 791097 791152 791132 791144 786473 791122 786475 791135 791086 832189 796201 79620 |
|---|
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-2322-2018%22
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