Medtronic Neuromodulation has recalled 4,925 SynchroMed II (Model 8637) and SynchroMed III (Model 8667) implantable pump systems due to software issues in the A810 CP application (version 2.x) used on clinician tablets. These devices are implanted in patients to deliver medication, and the software defect may interfere with proper pump settings or performance. No injuries or incidents have been reported, but Medtronic initiated the recall to address potential dosing errors. Healthcare providers at specialized facilities where these pumps were sold have been notified by mail.
Defects in the clinician tablet software could lead to incorrect programming of the implantable pump, potentially resulting in the over-delivery or under-delivery of medication. Such dosing errors could cause serious health complications depending on the specific drug being administered via the pump.
Recall Z-0771-2025; 319 systems distributed.
Recall Z-0772-2025; 59 systems distributed.
Recall Z-0773-2025; 566 systems distributed.
Recall Z-0774-2025; 3981 systems distributed. Clinician tablets include GLBL SMSNG and PAPER EN models.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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