Recall Z-1128-2022
Medtronic Neuromodulation · initiated March 30, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Codes / lots: Model: B35200; Expiration Range: 11/14/2021-02/14/2024; GTIN/UPN: 00763000253363, Serial Numbers: NPI702363H, NPI702456H, NPI702503H, NPI702504H, NPI702543H, NPI702551H, NPI702575H, NPI703408H, NPI703516H, NPI703553H, NPI703635H, NPI703969H, NPI703972H, NPI704070H, NPI704084H, NPI704097H, NPI704103H, NPI704104H, NPI704106H, NPI704107H, NPI704117H, NPI704118H, NPI704120H, NPI704121H, NPI704122H, NPI704123H, NPI704124H, NPI704125H, NPI704126H, NPI704127H, NPI704128H, NPI704129H, NPI704130H, NPI704131H, NPI704132H, NPI704133H, NPI704134H, NPI704135H, NPI704136H, NPI704137H, NPI704138H, NPI704140H, NPI704145H, NPI704146H, NPI704147H, NPI704152H, NPI704153H, NPI704156H, NPI704157H, NPI704158H, NPI704159H, NPI704160H, NPI704161H, NPI704163H, NPI704164H, NPI704165H, NPI704166H, NPI704172H, NPI704173H, NPI704178H, NPI704181H, NPI704182H, NPI704183H, NPI704184H, NPI704185H, NPI704186H, NPI704189H, NPI704190H, NPI704192H, NPI704193H, NPI704194H, NPI704195H, NPI704196H, NPI704197H, NPI704198H, NPI704201H, NPI704202H, NPI704203H, NPI704206H, NPI704208H, NPI704209H, NPI704210H, NPI704211H, NPI704212H, NPI704213H, NPI704217H, NPI704218H, NPI704220H, NPI704221H, NPI704223H, NPI704225H…
Reason for recall
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
FDA-determined cause: Under Investigation by firm
Action taken
A customer letter, dated March 2022, was issued to the impacted consignee via mail. The consignee is instructed to ensure the patient programmer system is set up to communicate with the patient's INS at the patient's initial programming session. If a patient's INS cannot communicate with the clinician programmer and/or patient programmer system, and it is not possible to make therapy adjustments or turn stimulation off, the consignee should contact Medtronic Technical Services at 1-800-707-0933. The consignee is also asked to complete the customer confirmation form and submit to the recalling firm.
Details
- Recall number
- Z-1128-2022
- Initiated
- March 30, 2022
- Product code
- MHY – Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Quantity
- 14164 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Croatia, Czech…
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1129-2022 Class II | Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient… | 03/30/2022Open, Classified |