FDA Device recall Z-2325-2018
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177 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-2325-2018 |
| 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
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
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 #: 1017247 1017246 1017239 1017238 1017248 1017242 1017243 1017245 1017240 1065733 1065741 1065742…Serial #: 1017247 1017246 1017239 1017238 1017248 1017242 1017243 1017245 1017240 1065733 1065741 1065742 1062125 1062118 1062120 1065717 1081661 1075944 1075939 1081656 1065721 1081665 1065724 1065734 1110961 1110163 1065740 1062122 1104243 1106558 1104245 1104238 1062128 1081658 1062119 1106557 1106559 1106560 1109554 1110161 1106561 1109553 1106563 1065731 1106564 1062127 1113653 1110153 1110142 1075936 1110970 1106556 1110146 1110957 1110128 1110947 1113663 1110954 1065736 1065738 1062126 1063635 1062153 1084907 1069184 1063622 1069786 1063145 1063152 1063475 1063634 1063129 1063604 1063612 1063160 1063163 1063148 1062164 1063640 1063648 1063157 1063618 1063461 1063643 1062174 1062159 1063617 1062141 1063613 1069167 1063621 1063629 1062133 1062152 1062157 1063631 1062167 1063632 1076754 1069172 1062134 1063649 1062149 1062132 1063650 1076736 1063642 1069176 1063609 1062171 |
|---|
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-2325-2018%22
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