Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.
Reason for recall: Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity. Distribution: U.S.: Nation-wide O.U.S.: Australia, Austria, Bahrain, Belgium, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Nepal, Netherlands, New Zealand, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Swed Quantity: 29,088 devices Lot/code info: Gallant: Model Number: HF CRT-D REF CDHFA500Q UDI-DI Code: 05415067032010 Serial Numbers: 111023714 111033397 111026077 111008528 810007304 810023031 111009077 810007164 111036262 111026540 111013180 810020124 111040419 111042048 810022176 111029687 111006406 111017718 810008795 111012956 111016597 810022867 810018823 810006029 810027443 810000072 810016983 111011034 111015410 810006013 111009628 111018199 111030383 810026178 111037835 111038995 111039205 111039169 111039213 111039103 111039227 111039172 111039154 111039298 111038919 111040351 111037720 111037178 111037142 111005031 810019888 810007234 111028528 111001728 111001715 111000681 111000233 111000202 111000235 111001707 111001777 111000294 111015428 111000224 111000494 111016493 111015792 111001752 111001687 111021218 111021101 111009661 111010339 111010612 111010599 111010615 111036821 111043197 111037844 111014472 111005935 111014496 111006045 111006001 111016094 810027416 810000369 810003198 111028551 111028566 111028556 810019969 810011841 810011914 111042858 111008829 810013774 810018766 810017010 810015486 810009746 810005988 810006054 810023114 111012399 810009476 810011649 111011036 810027614 810012107 810024932 111021623 111012101 111003756 810020343 810003891 111009278 810023576 810013854 111015681 111003733 810009559 810014126 111010585 810024290 810022925 111008862 111012548 810016189 810017522 810009554 111015794 810019965 810011865 111040526 810009812 810012821 111015675 111011312 111011387 111011336
05415067032010
Official record: FDA (Device enforcement) ↗
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