| | Class 2 Device Recall Medtronic Neuromodulation |  |
| Date Initiated by Firm | May 13, 2026 |
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| Date Posted | May 28, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2240-2026 |
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| Recall Event ID |
98913 |
| PMA Number | P960009 |
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| Product Classification |
Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
|
| Product | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor |
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| Code Information |
GTIN 00643169090866, Lot Number VA368G3;
GTIN 00643169090866, Lot Number VA36V7T;
GTIN 00643169936584, Lot Number VA3347Y;
GTIN 00643169936584, Lot Number VA33481;
GTIN 00643169936584, Lot Number VA33M8V;
GTIN 00643169936584, Lot Number VA33M92;
GTIN 00643169936584, Lot Number VA33T31;
GTIN 00643169936584, Lot Number VA33T33;
GTIN 00643169936584, Lot Number VA35B5D;
GTIN 00643169936584, Lot Number VA35B5E;
GTIN 00643169936584, Lot Number VA35WSP;
GTIN 00643169936584, Lot Number VA35WSU;
GTIN 00763000963040, Lot Number VA35TTU;
GTIN 00763000963040, Lot Number VA35TTV;
GTIN 00763000963040, Lot Number VA368FZ;
GTIN 00763000963040, Lot Number VA368G3;
GTIN 00763000963040, Lot Number VA36V7T;
GTIN 00763000963040, Lot Number VA36V8Q;
GTIN 00763000968427, Lot Number 0231980220;
GTIN 00763000968427, Lot Number 0231980221;
GTIN 00763000968427, Lot Number 0231980222;
GTIN 00763000968434, Lot Number 0231493884;
GTIN 00763000968434, Lot Number 0231493885;
GTIN 00763000968434, Lot Number 0231494066;
GTIN 00763000968434, Lot Number 0231928923;
GTIN 00763000968434, Lot Number 0231929188;
GTIN 00763000968434, Lot Number 0231929189;
GTIN 00763000968434, Lot Number 0231929192;
GTIN 00763000968441, Lot Number 0231367316;
GTIN 00763000968441, Lot Number 0231367317;
GTIN 00763000968441, Lot Number 0231367319;
GTIN 00763000968441, Lot Number 0231367320;
GTIN 00763000968441, Lot Number 0231367321;
GTIN 00763000968441, Lot Number 0231367322;
GTIN 00763000968441, Lot Number 0231514399;
GTIN 00763000968441, Lot Number 0231514400;
GTIN 00763000968441, Lot Number 0231514401;
GTIN 00763000968441, Lot Number 0231514402;
GTIN 00763000968441, Lot Number 0231514403;
GTIN 00763000968441, Lot Number 0231514404;
GTIN 00763000968441, Lot Number 0231514405;
GTIN 00763000968441, Lot Number 0231514406;
GTIN 00763000968441, Lot Number 0231514407;
GTIN 00763000968441, Lot Number 0231514408;
GTIN 00763000968441, Lot Number 0231514409;
GTIN 00763000968441, Lot Number 0231514410;
GTIN 00763000968441, Lot Number 0231514411;
GTIN 00763000968441, Lot Number 0231514412;
GTIN 00763000968441, Lot Number 0231514413;
GTIN 00763000968441, Lot Number 0231929193;
GTIN 00763000968441, Lot Number 0231929194;
GTIN 00763000968441, Lot Number 0231929195;
GTIN 00763000968441, Lot Number 0231929196;
GTIN 00763000968441, Lot Number 0231929197;
GTIN 00763000968441, Lot Number 0231929198;
GTIN 00763000968441, Lot Number 0231929199;
GTIN 00763000968441, Lot Number 0231929200;
GTIN 00763000968441, Lot Number 0231929201;
GTIN 00763000968441, Lot Number 0232153351;
GTIN 00763000968441, Lot Number 0232153352;
GTIN 00763000968441, Lot Number 0232153353;
GTIN 00763000968441, Lot Number 0232153354;
GTIN 00763000968441, Lot Number 0232153355;
GTIN 00763000968441, Lot Number 0232153360;
GTIN 00763000968441, Lot Number 0232212159;
GTIN 00763000968441, Lot Number 0232212160;
GTIN 00763000968441, Lot Number 0232212161;
GTIN 00763000968441, Lot Number 0232224165;
GTIN 00763000968441, Lot Number 0232224206;
GTIN 00763000968441, Lot Number 0232224207;
GTIN 00763000968441, Lot Number 0232224208;
GTIN 00763000968441, Lot Number 0232224209;
GTIN 00763000968441, Lot Number 0232224211;
GTIN 00763000968441, Lot Number 0232224212;
GTIN 00763000968441, Lot Number 0232224213;
GTIN 00763000968441, Lot Number 0232224214;
GTIN 00763000968441, Lot Number 0232224215;
GTIN 00763000968441, Lot Number 0232224216;
GTIN 00763000968441, Lot Number 0232224217;
GTIN 00763000968441, Lot Number 0232224218;
GTIN 00763000968441, Lot Number 0232546510;
GTIN 00763000968441, Lot Number 0232546511;
GTIN 00763000968441, Lot Number 0232554256;
GTIN 00763000968441, Lot Number 0232554257;
GTIN 00763000968441, Lot Number 0232589003;
GTIN 00763000968441, Lot Number 0232589646;
GTIN 00763000968441, Lot Number 0232589647;
GTIN 00763000968441, Lot Number 0232589648;
GTIN 00763000968441, Lot Number 0232589649;
GTIN 00763000968441, Lot Number 0232589651;
GTIN 00763000968441, Lot Number 0232676531;
GTIN 00763000968441, Lot Number 0232676532;
GTIN 00763000968441, Lot Number 0232676533;
GTIN 00763000968441, Lot Number 0232676534;
GTIN 00763000968441, Lot Number 0232676535;
GTIN 00763000968441, Lot Number 0232676536;
GTIN 00763000968441, Lot Number 0232676537;
GTIN 00763000968441, Lot Number 0232676539;
GTIN 00763000968441, Lot Number 0232676540;
GTIN 00763000968441, Lot Number 0232676541;
GTIN 00763000968441, Lot Number 0232725690;
GTIN 00763000968441, Lot Number 0232725694;
GTIN 00763000968441, Lot Number 0232725695;
GTIN 00763000968441, Lot Number 0232725696;
GTIN 00763000968441, Lot Number 0232725699. |
| FEI Number |
2182207
|
Recalling Firm/
Manufacturer |
Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
|
| For Additional Information Contact | Naomi Rodiles
763-514-2000 |
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Manufacturer Reason
for Recall | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 5/13/2026 via UPS 2 day mail. The notice described the issue and requested the following:
Actions:
" Identify and segregate affected products within your inventory.
" Return all unused affected product(s) to Medtronic as described in the Consignee Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected product.
" Share this notice with all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.
" Complete and return the consignee confirmation form even if you do not have unused inventory.
For questions regarding this communication, please contact your Medtronic Representative or Technical Services at 1-800-707-0933. |
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| Quantity in Commerce | 275 units |
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| Distribution | Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| PMA Database | PMAs with Product Code = MHY
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