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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-0773-2025
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 CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
Code Information GTIN: 00763000094027 00763000077730 00763000421007 00763000447090; Serial Numbers: NPL3000006 NPL3000007 NPL3000009 NPL3000011 NPL3000016 NPL3000017 NPL3000023 NPL3000026 NPL3000029 NPL3000043 NPL3000046 NPL3000050 NPL3000055 NPL3000063 NPL3000068 NPL3000083 NPL3000090 NPL3000103 NPL3000105 NPL3000129 NPL3000185 NPL3000186 NPL3000187 NPL3000189 NPL3000191 NPL3000192 NPL3000197 NPL3000198 NPL3000203 NPL3000205 NPL3000206 NPL3000209 NPL3000210 NPL3000215 NPL3000216 NPL3000219 NPL3000222 NPL3000223 NPL3000229 NPL3000232 NPL3000237 NPL3000240 NPL3000242 NPL3000246 NPL3000248 NPL3000250 NPL3000252 NPL3000253 NPL3000255 NPL3000262 NPL3000264 NPL3002259 NPL3002261 NPL3002266 NPL3002273 NPL3002274 NPL3002275 NPL3002278 NPL3002283 NPL3002288 NPL3002296 NPL3002306 NPL3002655 NPL3002660 NPL3002661 NPL3002666 NPL3002667 NPL3002669 NPL3002670 NPL3002672 NPL3002679 NPL3002685 NPL3002686 NPL3002687 NPL3002693 NPL3002694 NPL3002699 NPL3002700 NPL3002702 NPL3002703 NPL3002704 NPL3002705 NPL3002706 NPL3002707 NPL3002710 NPL3002716 NPL3002717 NPL3002718 NPL3002719 NPL3002723 NPL3002727 NPL3002732 NPL3002734 NPL3002735 NPL3002736 NPL3002737 NPL3002738 NPL3002739 NPL3002741 NPL3002745 NPL3002747 NPL3002752 NPL3002756 NPL3002757 NPL3002872 NPL3002874 NPL3002875 NPL3002878 NPL3002879 NPL3002880 NPL3002881 NPL3002885 NPL3002891 NPL3002892 NPL3002898 NPL3002899 NPL3002902 NPL3002906 NPL3002907 NPL3002908 NPL3002909 NPL3002910 NPL3002911 NPL3002914 NPL3002915 NPL3002918 NPL3002922 NPL3002924 NPL3002925 NPL3002927 NPL3002940 NPL3002942 NPL3002949 NPL3002950 NPL3002961 NPL3003300 NPL3003310 NPL3003311 NPL3003313 NPL3003315 NPL3003317 NPL3003325 NPL3003337 NPL3003339 NPL3003355 NPL3003359 NPL3003513 NPL3003558 NPL3003560 NPL3003570 NPL3003694 NPL3003696 NPL3003700 NPL3003705 NPL3003720 NPL3003725 NPL3003735 NPL3003737 NPL3003987 NPL3004860 NPL3004870 NPL3004879 NPL3004880 NPL3004914 NPL3004942 NPL3004951 NPL3004960 NPL3004992 NPL3005006 NPL3005009 NPL3005018 NPL3005769 NPL3005790 NPL3005843 NPL3006011 NPL3006034 NPL3006074 NPL3006084 NPL3006190 NPL3006192 NPL3006194 NPL3006209 NPL3006213 NPL3006238 NPL3006242 NPL3006244 NPL3006267 NPL3006272 NPL3006275 NPL3006280 NPL3006286 NPL3006287 NPL3006289 NPL3006295 NPL3006310 NPL3006374 NPL3006375 NPL3006377 NPL3006380 NPL3006381 NPL3006392 NPL3006398 NPL3006400 NPL3006406 NPL3006410 NPL3006414 NPL3006433 NPL3006458 NPL3006465 NPL3006469 NPL3006470 NPL3006476 NPL3006482 NPL3006483 NPL3006484 NPL3006485 NPL3006486 NPL3006487 NPL3006489 NPL3006494 NPL3006498 NPL3006518 NPL3006522 NPL3006525 NPL3006536 NPL3006625 NPL3006888 NPL3006911 NPL3006931 NPL3006934 NPL3006944 NPL3006946 NPL3006966 NPL3006967 NPL3006983 NPL3006986 NPL3007372 NPL3007388 NPL3007390 NPL3007391 NPL3007591 NPL3007592 NPL3007619 NPL3007621 NPL3007623 NPL3007628 NPL3007873 NPL3007874 NPL3007892 NPL3007895 NPL3007896 NPL3007897 NPL3007905 NPL3007908 NPL3007910 NPL3007914 NPL3007917 NPL3007918 NPL3007921 NPL3008033 NPL3008034 NPL3008039 NPL3008046 NPL3008053 NPL3010587 NPL3010593 NPL3010645 NPL3010652 NPL3010653 NPL3010658 NPL3010660 NPL3010665 NPL3010714 NPL3010722 NPL3010726 NPL3010732 NPL3010736 NPL3010739 NPL3010748 NPL3010750 NPL3010752 NPL3010759 NPL3010760 NPL3010761 NPL3010764 NPL3010769 NPL3010782 NPL3010791 NPL3010795 NPL3010835 NPL3010862 NPL3010864 NPL3010867 NPL3010870 NPL3010873 NPL3010878 NPL3010889 NPL3010902 NPL3010904 NPL3010905 NPL3010906 NPL3010912 NPL3010914 NPL3010946 NPL3010949 NPL3010953 NPL3010987 NPL3010988 NPL3010996 NPL3010997 NPL3011113 NPL3011219 NPL3011235 NPL3011236 NPL3011240 NPL3011241 NPL3011245 NPL3011246 NPL3011259 NPL3011269 NPL3011292 NPL3011296 NPL3011309 NPL3011316 NPL3011319 NPL3011323 NPL3011330 NPL3011331 NPL3011336 NPL3011347 NPL3011349 NPL3011353 NPL3011357 NPL3011362 NPL3011363 NPL3011369 NPL3011430 NPL3011449 NPL3011452 NPL3011460 NPL3011462 NPL3011463 NPL3011572 NPL3011600 NPL3011606 NPL3011709 NPL3013656 NPL3013676 NPL3013679 NPL3013680 NPL3013683 NPL3013712 NPL3013715 NPL3013721 NPL3013743 NPL3013759 NPL3013782 NPL3013786 NPL3013904 NPL3013906 NPL3013916 NPL3013964 NPL3013967 NPL3013969 NPL3013970 NPL3014054 NPL3014056 NPL3014059 NPL3014064 NPL3014066 NPL3014070 NPL3014071 NPL3014073 NPL3014076 NPL3014087 NPL3014289 NPL3014291 NPL3014292 NPL3014297 NPL3014305 NPL3014307 NPL3014317 NPL3014321 NPL3014322 NPL3014323 NPL3014325 NPL3014334 NPL3014335 NPL3014455 NPL3014456 NPL3014457 NPL3014459 NPL3014501 NPL3014521 NPL3014522 NPL3014586 NPL3015558 NPL3015565 NPL3016409 NPL3016410 NPL3016411 NPL3016419 NPL3016420 NPL3016421 NPL3016440 NPL3016447 NPL3016448 NPL3016449 NPL3016453 NPL3016461 NPL3016464 NPL3016465 NPL3016469 NPL3016478 NPL3016493 NPL3016495 NPL3016499 NPL3016506 NPL3016507 NPL3016513 NPL3016522 NPL3016539 NPL3016592 NPL3016594 NPL3016600 NPL3016601 NPL3016606 NPL3016607 NPL3016608 NPL3016617 NPL3016738 NPL3016761 NPL3016763 NPL3016766 NPL3016775 NPL3016776 NPL3016780 NPL3016790 NPL3016795 NPL3016796 NPL3016800 NPL3016801 NPL3016995 NPL3017197 NPL3017200 NPL3017201 NPL3017214 NPL3017221 NPL3017252 NPL3017254 NPL3017260 NPL3017266 NPL3017267 NPL3017269 NPL3017272 NPL3017286 NPL3017287 NPL3017289 NPL3017290 NPL3017312 NPL3017313 NPL3017316 NPL3017320 NPL3017335 NPL3017413 NPL3017414 NPL3017427 NPL3017611 NPL3017614 NPL3017625 NPL3017629 NPL3017630 NPL3017654 NPL3017692 NPL3017706 NPL3017727 NPL3017774 NPL3017779 NPL3017891 NPL3017895 NPL3017897 NPL3017898 NPL3018033 NPL3018049 NPL3018050 NPL3018534 NPL3018537 NPL3018579 NPL3018655 NPL3018659 NPL3018709 NPL3018711 NPL3018718 NPL3018724 NPL3018727 NPL3018747 NPL3018749 NPL3018763 NPL3018765 NPL3018766 NPL3018769 NPL3018809 NPL3018894 NPL3019477 NPL3019531 NPL3019532 NPL3019533 NPL3019534 NPL3019535 NPL3019539 NPL3019541 NPL3019548 NPL3019552 NPL3019585 NPL3019586 NPL3019607 NPL3019666 NPL3019668 NPL3019672 NPL3019678 NPL3019698 NPL3019699 NPL3019737 NPL3020103 NPL3020104 NPL3020107 NPL3020108 NPL3020121 NPL3020134 NPL3020139 NPL3020151 NPL3020153 NPL3020155 NPL3020168 NPL3020170 NPL3020210 NPL3020958 NPL3020959 NPL3020960 NPL3020986 NPL3020987 NPL3020988 NPL3020990 NPL3020991 NPL3021003 NPL3021015 NPL3021025 NPL3021031 NPL3021052 NPL3021261 NPL3021465 NPL3021467 NPL3021468 NPL3021471 NPL3021479 NPL3021480 NPL3021481 NPL3021485 NPL3021487 NPL3021488 NPL3021490 NPL3021491 NPL3021559 NPL3021565 NPL3021567 NPL3013740
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information ContactNaomi Rodiles
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. ***Update January 2026*** An URGENT: MEDICAL DEVICE CORRECTION notification letter dated January 2026 was sent to customers. The purpose of this letter is to inform you that a new version of the Model A810 SynchroMed Clinician Programmer Application (CP App), v2.0.3320, is now available for installation. This update addresses previously communicated software issues associated with earlier versions used for the Model 8637 SynchroMed II and Model 8667 SynchroMed III infusion pumps. These issues were initially communicated to you in the letter enclosed from November 2024. The new version of the A810 CP App resolves these issues. Customer Actions: " Download and install A810 CP App v2.0.3320 at your earliest convenience and contact your local Medtronic representative if you have any questions related to the update. " Sign and return the Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. Retain a copy of this lette
Quantity in Commerce566 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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