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U.S. Department of Health and Human Services

Class 2 Device Recall A810 CP app

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 Class 2 Device Recall A810 CP appsee related information
Date Initiated by FirmNovember 21, 2024
Date PostedDecember 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0772-2025
Recall Event ID 95845
PMA NumberP860004S404 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
ProductSynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
Code Information GTIN: 00643169890961; Serial Numbers: NPL1000442 NPL1000448 NPL1000453 NPL1000765 NPL1000776 NPL1000797 NPL1000809 NPL1000810 NPL1000811 NPL1000813 NPL1000814 NPL1000815 NPL1000817 NPL1000818 NPL1000819 NPL1000827 NPL1000830 NPL1000834 NPL1000835 NPL1000858 NPL1001552 NPL1001558 NPL1001564 NPL1001566 NPL1001574 NPL1001583 NPL1001590 NPL1001591 NPL1001592 NPL1001594 NPL1001595 NPL1001601 NPL1001608 NPL1001615 NPL1001620 NPL1001629 NPL1001630 NPL1001631 NPL1001650 NPL1001651 NPL1001656 NPL1001670 NPL1001675 NPL1002257 NPL1002259 NPL1002260 NPL1002264 NPL1002265 NPL1002266 NPL1002267 NPL1002281 NPL1002282 NPL1002284 NPL1002286 NPL1002288 NPL1002295 NPL1002297 NPL1002308 NPL1002309
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information ContactJeffrey Trauring
763-514-2000
Manufacturer Reason
for Recall		Software issues were identified in application version 2.x.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn URGENT: MEDICAL DEVICE CORRECTION notification letter dated November 2024 was sent to customers. Actions Share this notice with all those who need to be aware of this issue within your organization and maintain a copy of this notice in your records. Please complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. Additional Information Medtronic is actively working on a permanent solution and will inform you as soon as it becomes available. Medtronic is communicating this information to the appropriate regulatory agencies. Adverse events or quality problems experienced with this product should be reported to Medtronic and the FDA MedWatch Adverse Event Reporting program via: Medtronic email at RS.NeuAdverseEventReporting@Medtronic.com or Medtronic Technical Services at 1-800-707-0933 weekdays 7:00 AM 6:00 PM CT.
Quantity in Commerce59 systems
DistributionWorldwide - US Nationwide distribution.
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 = LKK
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