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U.S. Department of Health and Human Services

Class 3 Device Recall Merlinhome

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 Class 3 Device Recall Merlinhomesee related information
Date Initiated by FirmOctober 01, 2024
Date PostedNovember 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0551-2025
Recall Event ID 95557
PMA NumberP910023S191 
Product Classification Pulse generator, permanent, implantable - Product Code NVZ
ProductMerlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.
Code Information Model Number: EX1100 UDI-DI code: Pending Serial Numbers: 12600224 12600307 12600895 12600974 12601074 12601156 12601169 12602176 12602216 12602464 12602491 12604265 12604852 12606254 12606332 12606531 12606550 12606551 12606587 12606785 12606814 12607289 12607557 12608093 12608346 12608623 12608678 12608758 12608819 12609094 12609148 12609819 12609919 12610472 12610550 12611493 12611733 12611975 12612409 12612417 12612541 12612929 12613146 12613636 12617342 12617350 12617583 12617821 12618054 12618130 12618726 12618782 12619218 12619405 12619515 12619825 12619827 12620745 12621171 12622233 12622283 12622473 12623904 12625575 12625701 12625874 12628403 12628624 12628626 12634096 12634120 12634141 12634152 12634208 12635184 12635287 12636062 12636067 12636127 12636195 12638900 12639020 12640950 12641103 12641819 12643036 12643543 12643551 12643589 12643621 12643623 12643640 12643744 12643781 12643792 12647278 12647327 12647343 12647350 12647621 12647781 12647787 12647789 12647904 12647923 12647939 12647940 12648513 12648520 12648589 12648611 12648704 12648839 12649443 12649481 12649517 12650938 12651018 12651022 12651051 12651056 12651073 12651198 12651419 12651476 12651597 12652036 12652060 12652070 12652076
Recalling Firm/
Manufacturer		 Abbott Medical
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information ContactAlicia Swanson,
408-845-3427
Manufacturer Reason
for Recall		Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
FDA Determined
Cause 2		Software design
ActionOn 10/25/2024, the firm initiated notifying customers in person/verbally regarding a limited number of Merlin@home Transmitters with MerlinOnDemand Capability that are unable to upgrade to the latest version of software. This issue was caused by a power interruption during a past software updated attempt. Abbott will be retrieving and replacing the affected Transmitters. The replacement Transmitter will have the latest software update version 9.0rev1 For questions or further assistance, speak with or contact the Abbott representative that is on-site replacing the Transmitter, or contact the Public Contact at 408-845-3427
Quantity in Commerce130 transmitters
DistributionWorldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYLVANIA, SOUTH CAROLINA, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON and WISCONSIN. The country of Australia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = NVZ
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