Class 2 Device Recall A810 CP app

• Date Initiated by Firm: November 21, 2024
• Date Posted: December 27, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0771-2025
• Recall Event ID: 95845
• PMA Number: P860004S404
• Product Classification: Pump, infusion, implanted, programmable - Product Code LKK
• Product: SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
• Code Information: GTIN: 00643169890947, 00763000447090; Serial Numbers: NPL1000037 NPL1000042 NPL1000045 NPL1000048 NPL1000051 NPL1000054 NPL1000055 NPL1000056 NPL1000062 NPL1000069 NPL1000072 NPL1000073 NPL1000074 NPL1000075 NPL1000078 NPL1000083 NPL1000092 NPL1000093 NPL1000094 NPL1000096 NPL1000098 NPL1000132 NPL1000151 NPL1000159 NPL1000161 NPL1000165 NPL1000166 NPL1000173 NPL1000174 NPL1000179 NPL1000180 NPL1000185 NPL1000186 NPL1000189 NPL1000191 NPL1000195 NPL1000196 NPL1000230 NPL1000233 NPL1000238 NPL1000239 NPL1000249 NPL1000257 NPL1000281 NPL1000297 NPL1000301 NPL1000303 NPL1000321 NPL1000323 NPL1000325 NPL1000331 NPL1000334 NPL1000343 NPL1000344 NPL1000361 NPL1000363 NPL1000367 NPL1000370 NPL1000486 NPL1000501 NPL1000504 NPL1000505 NPL1000506 NPL1000507 NPL1000509 NPL1000510 NPL1000515 NPL1000516 NPL1000518 NPL1000519 NPL1000528 NPL1000555 NPL1000556 NPL1000558 NPL1000561 NPL1000562 NPL1000563 NPL1000571 NPL1000573 NPL1000574 NPL1000584 NPL1000585 NPL1000592 NPL1000603 NPL1000606 NPL1000612 NPL1000627 NPL1000630 NPL1000631 NPL1000632 NPL1000634 NPL1000638 NPL1000639 NPL1001196 NPL1001209 NPL1001212 NPL1001214 NPL1001216 NPL1001228 NPL1001235 NPL1001236 NPL1001237 NPL1001241 NPL1001243 NPL1001245 NPL1001247 NPL1001249 NPL1001252 NPL1001259 NPL1001260 NPL1001265 NPL1001273 NPL1001277 NPL1001292 NPL1001293 NPL1001294 NPL1001296 NPL1001297 NPL1001298 NPL1001301 NPL1001304 NPL1001314 NPL1001323 NPL1001324 NPL1001325 NPL1001328 NPL1001330 NPL1001332 NPL1001333 NPL1001336 NPL1001337 NPL1001345 NPL1001353 NPL1001360 NPL1001361 NPL1001362 NPL1001363 NPL1001364 NPL1001366 NPL1001371 NPL1001374 NPL1001381 NPL1001387 NPL1001389 NPL1001398 NPL1001402 NPL1001407 NPL1001419 NPL1001431 NPL1001435 NPL1001436 NPL1001445 NPL1001461 NPL1001465 NPL1001500 NPL1001511 NPL1001514 NPL1001520 NPL1001524 NPL1001526 NPL1001527 NPL1001531 NPL1001532 NPL1001537 NPL1001539 NPL1001542 NPL1001543 NPL1001544 NPL1001545 NPL1001547 NPL1001697 NPL1001701 NPL1001702 NPL1001705 NPL1001709 NPL1001717 NPL1001728 NPL1001748 NPL1001763 NPL1001764 NPL1001765 NPL1001766 NPL1001769 NPL1001770 NPL1001773 NPL1001785 NPL1001789 NPL1001790 NPL1001792 NPL1001794 NPL1001795 NPL1001797 NPL1001798 NPL1001800 NPL1001801 NPL1001802 NPL1001804 NPL1001811 NPL1001812 NPL1001815 NPL1001816 NPL1001823 NPL1001841 NPL1001847 NPL1001879 NPL1001881 NPL1001884 NPL1001891 NPL1001897 NPL1001905 NPL1001963 NPL1001966 NPL1001969 NPL1001970 NPL1001972 NPL1001973 NPL1001974 NPL1001976 NPL1001995 NPL1002000 NPL1002004 NPL1002013 NPL1002016 NPL1002017 NPL1002018 NPL1002022 NPL1002050 NPL1002053 NPL1002054 NPL1002088 NPL1002089 NPL1002091 NPL1002092 NPL1002211 NPL1002214 NPL1002219 NPL1002227 NPL1002231 NPL1002240 NPL1002243 NPL1002250 NPL1002311 NPL1002312 NPL1002327 NPL1002330 NPL1002333 NPL1002341 NPL1002343 NPL1002344 NPL1002347 NPL1002355 NPL1002358 NPL1002360 NPL1002363 NPL1002364 NPL1002401 NPL1002408 NPL1002409 NPL1002410 NPL1002418 NPL1002428 NPL1002433 NPL1002434 NPL1002438 NPL1002440 NPL1002443 NPL1002464 NPL1002490 NPL1002491 NPL1002492 NPL1002493 NPL1002505 NPL1002520 NPL1002521 NPL1002537 NPL1002540 NPL1002555 NPL1002556 NPL1002567 NPL1002572 NPL1002583 NPL1002587 NPL1002589 NPL1002598 NPL1002618 NPL1002620 NPL1002631 NPL1002632 NPL1002638 NPL1002639 NPL1002648 NPL1002649 NPL1002654 NPL1002661 NPL1002664 NPL1002665 NPL1002669 NPL1002672 NPL1002673 NPL1002674 NPL1002675 NPL1002689 NPL1002707 NPL1002714 NPL1002726 NPL1002730 NPL1002731 NPL1002732 NPL1002733 NPL1002740 NPL1002743 NPL1002751 NPL1002756 NPL1002757 NPL1002780 NPL1002781 NPL1002789 NPL1002792 NPL1002467
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave Ne; Minneapolis MN 55432-3568
• For Additional Information Contact: Jeffrey Trauring; 763-514-2000
• Manufacturer Reason for Recall: Software issues were identified in application version 2.x.
• FDA Determined Cause: Under Investigation by firm
• Action: An 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 Commerce: 319 systems
• Distribution: Worldwide - US Nationwide distribution.
• Total Product Life Cycle: TPLC 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 Database: PMAs with Product Code = LKK