Recall archive / FDA device enforcement
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL ... — FDA record Z-0774-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 21, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
- Reason
- Software issues were identified in application version 2.x.
- Classification
- Class II
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 3981 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0774-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN: 00763000447090 00763000729141 00763000737290 00763000447090; Serial Numbers: NPL3020725 NPL3021958 NPL3021963 NPL3021966 NPL3021969 NPL3021970 NPL3021971 NPL3021974 NPL3021983 NPL3021984 NPL3021990 NPL3021997 NPL3022002 NPL3022005 NPL3022014 NPL3022022 NPL3022031 NPL3022032 NPL3022038 NPL3022044 NPL3022052 NPL3022062 NPL3022069 NPL3022070 NPL3022071 NPL3022072 NPL3022073 NPL3022074 NPL3022109 NPL3022114 NPL3022118 NPL3022124 NPL3022125 NPL3022131 NPL3022139 NPL3022187 NPL3022190 NPL3022193 NPL3022194 NPL3022195 NPL3022212 NPL3022213 NPL3022216 NPL3022218 NPL3022245 NPL3022257 NPL3022278 NPL3022280 NPL3022289 NPL3022291 NPL3022304 NPL3022311 NPL3022313 NPL3022314 NPL3022328 NPL3022352 NPL3022357 NPL3022364 NPL3022365 NPL3022711 NPL3022713 NPL3022714 NPL3022715 NPL3022717 NPL3022735 NPL3022761 NPL3022762 NPL3022765 NPL3022767 NPL3022768 NPL3022769 NPL3022776 NPL3022791 NPL3022793 NPL3022795 NPL3022810 NPL3022811 NPL3022815 NPL3022817 NPL3022818 NPL3022831 NPL3022836 NPL3022838 NPL3022841 NPL3022844 NPL3022856 NPL3022858 NPL3022869 NPL3022870 NPL3022873 NPL3022874 NPL3022876 NPL3022877 NPL3022879 NPL3022893 NPL3022899 NPL3022900 NPL3022912 NPL3022918 NPL3022922 NPL3022926 NPL3022939 NPL3022940 NPL3022942 NPL3022954 NPL3022957 NPL3022958 NPL3022959 NPL3022968 NPL3022969 NPL3022973 NPL3022974 NPL3022981 NPL3022999 NPL3023030 NPL3023032 NPL3023035 NPL3023038 NPL3023042 NPL3023043 NPL3023048 NPL3023050 NPL3023054 NPL3023059 NPL3023061 NPL3023065 NPL3023067 NPL3023076 NPL3023078 NPL3023086 NPL3023093 NPL3023097 NPL3023123 NPL3023131 NPL3023132 NPL3023133 NPL3023136 NPL3023146 NPL3023148 NPL3023149 NPL3023150 NPL3023153 NPL3023156 NPL3023167 NPL3023175 NPL3023180 NPL3023192 NPL3023194 NPL3023197 NPL3023205 NPL3023218 NPL3023229 NPL3023237 NPL3023239 NPL3023241 NPL3023242 NPL3023245 NPL3023254 NPL3023256 NPL3023257 NPL3023260 NPL3023262 NPL3023268 NPL3023272 NPL3023278 NPL3023288 NPL3023292 NPL3023315 NPL3023317 NPL3023319 NPL3023322 NPL3023323 NPL3023330 NPL3023331 NPL3023340 NPL3023347 NPL3023351 NPL3023352 NPL3023364 NPL3023367 NPL3023368 NPL3023373 NPL3023380 NPL3023388 NPL3023389 NPL3023394 NPL3023409 NPL3023411 NPL3023415 NPL3023422 NPL3023423 NPL3023424 NPL3023425 NPL3023429 NPL3023432 NPL3023435 NPL3023437 NPL3023439 NPL3023440 NPL3023443 NPL3023446 NPL3023447 NPL3023448 NPL3023449 NPL3023450 NPL3023459 NPL3023460 NPL3023463 NPL3023464 NPL3023466 NPL3023467 NPL3023474 NPL3023491 NPL3023494 NPL3023498 NPL3023504 NPL3023510 NPL3023511 NPL3023512 NPL3023520 NPL3023526 NPL3023541 NPL3023548 NPL3023550 NPL3023554 NPL3023555 NPL3023556 NPL3023559 NPL3023563 NPL3023573 NPL3023583 NPL3023593 NPL3023597 NPL3023598 NPL3023599 NPL3023600 NPL3023602 NPL3023607 NPL3023610 NPL3023615 NPL3023620 NPL3023635 NPL3023638 NPL3023640 NPL3023642 NPL3023646 NPL3023647 NPL3023649 NPL3023651 NPL3023659 NPL3023660 NPL3023661 NPL3023664 NPL3023665 NPL3023666 NPL3023689 NPL3023690 NPL3023692 NPL3023695 NPL3023704 NPL3023708 NPL3023711 NPL3023716 NPL3023718 NPL3023722 NPL3023723 NPL3023728 NPL3023729 NPL3023734 NPL3023744 NPL3023751 NPL3023752 NPL3023760 NPL3023762 NPL3023776 NPL3023778 NPL3023781 NPL3023782 NPL3023784 NPL3023785 NPL3023792 NPL3023803 NPL3023809 NPL3023829 NPL3023830 NPL3023831 NPL3023837 NPL3023841 NPL3023852 NPL3023854 NPL3023855 NPL3023857 NPL3023858 NPL3023860 NPL3023868 NPL3023873 NPL3023885 NPL3023902 NPL3023905 NPL3023915 NPL3023922 NPL3023930 NPL3023933 NPL3023936 NPL3023938 NPL3023948 NPL3023949 NPL3023955 NPL3023957 NPL3023959 NPL3023974 NPL3023977 NPL3023980 NPL3023983 NPL3023984 NPL3023990 NPL3023991 NPL3023998 NPL3024013 NPL3024015 NPL3024022 NPL3024023 NPL3024024 NPL3024025 NPL3024026 NPL3024028 NPL3024031 NPL3024033 NPL3024037 NPL3024040 NPL3024043 NPL3024044 NPL3024046 NPL3024054 NPL3024055 NPL3024056 NPL3024059 NPL3024072 NPL3024079 NPL3024082 NPL3024084 NPL3024087 NPL3024088 NPL3024092 NPL3024099 NPL3024100 NPL3024102 NPL3024103 NPL3024108 NPL3024111 NPL3024113 NPL3024117 NPL3024122 NPL3024123 NPL3024124 NPL3024127 NPL3024129 NPL3024139 NPL3024145 NPL3024148 NPL3024149 NPL3024150 NPL3024151 NPL3024152 NPL3024153 NPL3024155 NPL3024158 NPL3024161 NPL3024162 NPL3024166 NPL3024167 NPL3024170 NPL3024176 NPL3024179 NPL3024185 NPL3024188 NPL3024193 NPL3024196 NPL3024197 NPL3024198 NPL3024199 NPL3024200 NPL3024206 NPL3024207 NPL3024208 NPL3024209 NPL3024210 NPL3024212 NPL3024218 NPL3024220 NPL3024221 NPL3024225 NPL3024230 NPL3024233 NPL3024234 NPL3024235 NPL3024239 NPL3024240 NPL3024245 NPL3024246 NPL3024247 NPL3024256 NPL3024257 NPL3024258 NPL3024261 NPL3024266 NPL3024274 NPL3024276 NPL3024277 NPL3024278 NPL3024280 NPL3024284 NPL3024294 NPL3024296 NPL3024298 NPL3024299 NPL3024300 NPL3024303 NPL3024305 NPL3024307 NPL3024308 NPL3024309 NPL3024310 NPL3024311 NPL3024312 NPL3024313 NPL3024316 NPL3024321 NPL3024324 NPL3024327 NPL3024328 NPL3024329 NPL3024337 NPL3024341 NPL3024348 NPL3024350 NPL3024355 NPL3024356 NPL3024358 NPL3024360 NPL3024367 NPL3024370 NPL3024379 NPL3024381 NPL3024384 NPL3024393 NPL3024395 NPL3024399 NPL3024404 NPL3024405 NPL3024407 NPL3024408 NPL3024416 NPL3024417 NPL3024418 NPL3024419 NPL3024420 NPL3024424 NPL3024428 NPL3024430 NPL3024437 NPL3024439 NPL3024440 NPL3024442 NPL3024452 NPL3024455 NPL3024461 NPL3024462 NPL3024464 NPL3024472 NPL3024478 NPL3024479 NPL3024480 NPL3024482 NPL3024484 NPL3024485 NPL3024486 NPL3024487 NPL3024490 NPL3024491 NPL3024492 NPL3024493 NPL3024498 NPL3024499 NPL3024501 NPL3024502 NPL3024507 NPL3024509 NPL3024518 NPL3024519 NPL3024523 NPL3024531 NPL3024533 NPL3024534 NPL3024540 NPL3024541 NPL3024542 NPL3024544 NPL3024545 NPL3024549 NPL3024550 NPL3024551 NPL3024552 NPL3024554 NPL3024555 NPL3024556 NPL3024557 NPL3024558 NPL3024559 NPL3024563 NPL3024565 NPL3024567 NPL3024569 NPL3024572 NPL3024574 NPL3024576 NPL3024578 NPL3024582 NPL3024583 NPL3024585 NPL3024587 NPL3024589 NPL3024592 NPL3024594 NPL3024596 NPL3024598 NPL3024600 NPL3024602 NPL3024603 NPL3024604 NPL3024606 NPL3024608 NPL3024610 NPL3024615 NPL3024618 NPL3024619 NPL3024621 NPL3024625 NPL3024626 NPL3024631 NPL3024632 NPL3024635 NPL3024637 NPL3024639 NPL3024642 NPL3024643 NPL3024647 NPL3024649 NPL3024654 NPL3024656 NPL3024657 NPL3024658 NPL3024659 NPL3024660 NPL3024661 NPL3024662 NPL3024664 NPL3024665 NPL3024669 NPL3024671 NPL3024673 NPL3024676 NPL3024678 NPL3024680 NPL3024688 NPL3024694 NPL3024702 NPL3024709 NPL3024712 NPL3024717 NPL3024721 NPL3024722 NPL3024726 NPL3024728 NPL3024729 NPL3024730 NPL3024731 NPL3024734 NPL3024736 NPL3024737 NPL3024739 NPL3024740 NPL3024748 NPL3024750 NPL3024751 NPL3024755 NPL3024758 NPL3024759 NPL3024764 NPL3024765 NPL3024769 NPL3024771 NPL3024772 NPL3024774 NPL3024775 NPL3024777 NPL3024778 NPL3024780 NPL3024782 NPL3024784 NPL3024785 NPL3024786 NPL3024787 NPL3024794 NPL3024797 NPL3024799 NPL3024800 NPL3024803 NPL3024807 NPL3024808 NPL3024817 NPL3024819 NPL3024821 NPL3024823 NPL3024827 NPL3024834 NPL3024838 NPL3024843 NPL3024851 NPL3024857 NPL3024858 NPL3024859 NPL3024861 NPL3024867 NPL3024869 NPL3024870 NPL3024872 NPL3024875 NPL3024884 NPL3024890 NPL3024896 NPL3024897 NPL3024899 NPL3024903 NPL3024905 NPL3024906 NPL3024909 NPL3024919 NPL3024921 NPL3024929 NPL3024933 NPL3024934 NPL3024935 NPL3024936 NPL3024939 NPL3024940 NPL3024943 NPL3024945 NPL3024950 NPL3024951 NPL3024953 NPL3024954 NPL3024956 NPL3024964 NPL3024970 NPL3024971 NPL3024972 NPL3024975 NPL3024980 NPL3024982 NPL3024983 NPL3024985 NPL3024988 NPL3024993 NPL3024995 NPL3024997 NPL3024998 NPL3024999 NPL3025002 NPL3025011 NPL3025021 NPL3025024 NPL3025025 NPL3025026 NPL3025047 NPL3025048 NPL3025057 NPL3025058 NPL3025060 NPL3025062 NPL3025068 NPL3025070 NPL3025074 NPL3025084 NPL3025090 NPL3025097 NPL3025103 NPL3025105 NPL3025117 NPL3025119 NPL3025132 NPL3025133 NPL3025146 NPL3025153 NPL3025158 NPL3025160 NPL3025164 NPL3025167 NPL3025169 NPL3025179 NPL3025180 NPL3025185 NPL3025191 NPL3025197 NPL3025207 NPL3025217 NPL3025224 NPL3025227 NPL3025228 NPL3025231 NPL3025234 NPL3025237 NPL3025240 NPL3025241 NPL3025244 NPL3025249 NPL3025252 NPL3025253 NPL3025257 NPL3025263 NPL3025265 NPL3025270 NPL3025271 NPL3025275 NPL3025281 NPL3025289 NPL3025300 NPL3025302 NPL3025304 NPL3025305 NPL3025309 NPL3025312 NPL3025313 NPL3025320 NPL3025322 NPL3025327 NPL3025329 NPL3025331 NPL3025332 NPL3025335 NPL3025338 NPL3025339 NPL3025344 NPL3025354 NPL3025356 NPL3025370 NPL3025382 NPL3025385 NPL3025386 NPL3025388 NPL3025392 NPL3025394 NPL3025397 NPL3025409 NPL3025410 NPL3025419 NPL3025424 NPL3025433 NPL3025436 NPL3025439 NPL3025441 NPL3025446 NPL3025448 NPL3025449 NPL3025451 NPL3025452 NPL3025454 NPL3025458 NPL3025461 NPL3025462 NPL3025465 NPL3025466 NPL3025468 NPL3025470 NPL3025477 NPL3025479 NPL3025480 NPL3025482 NPL3025483 NPL3025490 NPL3025494 NPL3025502 NPL3025506 NPL3025508 NPL3025509 NPL3025513 NPL3025514 NPL3025515 NPL3025518 NPL3025526 NPL3025527 NPL3025530 NPL3025532 NPL3025533 NPL3025534 NPL3025535 NPL3025538 NPL3025542 NPL3025547 NPL3025549 NPL3025558 NPL3025562 NPL3025563 NPL3025572 NPL3025576 NPL3025577 NPL3025580 NPL3025584 NPL3025588 NPL3025589 NPL3025591 NPL3025595 NPL3025596 NPL3025598 NPL3025600 NPL3025601 NPL3025602 NPL3025606 NPL3025613 NPL3025617 NPL3025620 NPL3025621 NPL3025622 NPL3025624 NPL3025625 NPL3025629 NPL3025633 NPL3025638 NPL3025642 NPL3025644 NPL3025646 NPL3025649 NPL3025650 NPL3025652 NPL3025653 NPL3025661 NPL3025667 NPL3025669 NPL3025673 NPL3025674 NPL3025676 NPL3025677 NPL3025686 NPL3025689 NPL3025690 NPL3025691 NPL3025697 NPL3025703 NPL3025704 NPL3025707 NPL3025712 NPL3025713 NPL3025723 NPL3025725 NPL3025727 NPL3025739 NPL3025740 NPL3025741 NPL3025742 NPL3025745 NPL3025751 NPL3025754 NPL3025755 NPL3025757 NPL3025758 NPL3025775 NPL3025776 NPL3025777 NPL3025787 NPL3025795 NPL3025797 NPL3025799 NPL3025800 NPL3025807 NPL3025811 NPL3025813 NPL3025815 NPL3025816 NPL3025819 NPL3025820 NPL3025823 NPL3025825 NPL3025826 NPL3025827 NPL3025828 NPL3025832 NPL3025834 NPL3025837 NPL3025838 NPL3025839 NPL3025842 NPL3025845 NPL3025849 NPL3025850 NPL3025853 NPL3025855 NPL3025873 NPL3025879 NPL3025881 NPL3025882 NPL3025892 NPL3025893 NPL3025895 NPL3025900 NPL3025901 NPL3025908 NPL3025909 NPL3025916 NPL3025918 NPL3025921 NPL3025929 NPL3025932 NPL3025937 NPL3025938 NPL3025939 NPL3025946 NPL3025947 NPL3025949 NPL3025951 NPL3025953 NPL3025955 NPL3025963 NPL3025964 NPL3025965 NPL3025967 NPL3025975 NPL3025981 NPL3025998 NPL3025999 NPL3026005 NPL3026008 NPL3026009 NPL3026010 NPL3026012 NPL3026017 NPL3026019 NPL3026020 NPL3026021 NPL3026035 NPL3026038 NPL3026044 NPL3026050 NPL3026052 NPL3026053 NPL3026054 NPL3026057 NPL3026060 NPL3026061 NPL3026066 NPL3026068 NPL3026071 NPL3026076 NPL3026077 NPL3026081 NPL3026085 NPL3026088 NPL3026092 NPL3026094 NPL3026097 NPL3026099 NPL3026101 NPL3026102 NPL3026104 NPL3026108 NPL3026109 NPL3026111 NPL3026118 NPL3026120 NPL3026121 NPL3026123 NPL3026127 NPL3026134 NPL3026141 NPL3026142 NPL3026143 NPL3026144 NPL3026147 NPL3026148 NPL3026150 NPL3026151 NPL3026152 NPL3026153 NPL3026154 NPL3026155 NPL3026159 NPL3026161 NPL3026163 NPL3026165 NPL3026168 NPL3026169 NPL3026172 NPL3026173 NPL3026177 NPL3026178 NPL3026183 NPL3026184 NPL3026185 NPL3026187 NPL3026192 NPL3026193 NPL3026195 NPL3026196 NPL3026197 NPL3026198 NPL3026199 NPL3026201 NPL3026202 NPL3026203 NPL3026204 NPL3026206 NPL3026207 NPL3026208 NPL3026209 NPL3026210 NPL3026212 NPL3026215 NPL3026216 NPL3026217 NPL3026218 NPL3026221 NPL3026223 NPL3026224 NPL3026229 NPL3026233 NPL3026238 NPL3026241 NPL3026244 NPL3026245 NPL3026250 NPL3026258 NPL3026259 NPL3026261 NPL3026262 NPL3026263 NPL3026264 NPL3026267 NPL3026270 NPL3026271 NPL3026272 NPL3026273 NPL3026274 NPL3026275 NPL3026286 NPL3026289 NPL3026291 NPL3026292 NPL3026296 NPL3026300 NPL3026301 NPL3026303 NPL3026307 NPL3026313 NPL3026315 NPL3026317 NPL3026319 NPL3026321 NPL3026324 NPL3026325 NPL3026333 NPL3026334 NPL3026335 NPL3026337 NPL3026338 NPL3026343 NPL3026350 NPL3026351 NPL3026352 NPL3026356 NPL3026357 NPL3026358 NPL3026360 NPL3026362 NPL3026367 NPL3026374 NPL3026381 NPL3026382 NPL3026383 NPL3026384 NPL3026390 NPL3026391 NPL3026393 NPL3026396 NPL3026397 N... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 8, 2025
- Recall initiation date
- Nov 21, 2024
- Center classification date
- Dec 27, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.