{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88160",
      "recalling_firm": "Medtronic Neuromodulation",
      "address_1": "7000 Central Ave Ne",
      "address_2": "N/A",
      "postal_code": "55432-3568",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI,  WV and Hawaii",
      "recall_number": "Z-2228-2021",
      "product_description": "Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000",
      "product_quantity": "15,192",
      "reason_for_recall": "Excess nylon flash on the clip.",
      "recall_initiation_date": "20210602",
      "center_classification_date": "20210806",
      "report_date": "20210818",
      "code_info": "a) PART NUMBER: 3387S-40 - DBS Lead with StimLoc  LOTS # : VA21YUS, VA24RVV, VA25SDK, VA26Q2S, VA27X8H, VA2980G, VA29Z9A, VA2DA2Z,  VA21ZJU, VA24S65, VA25WK1, VA26XP2, VA27ZRF, VA29814, VA2A5MJ, VA2DA5Y, VA21ZYP,  VA24S66, VA2613V, VA26ZFU, VA281L5, VA2985H, VA2AK84, VA2DA9E, VA222L5, VA24SRF,  VA261EL, VA275SC, VA2820Y, VA29BSM, VA2APV8, VA2DEKH, VA227E2, VA24UVS, VA263GC,  VA275SD, VA282CS, VA29E09, VA2B3PB, VA2DVM9, VA22LDZ, VA24ZFG, VA26460, VA276GS, VA283SF, VA29LP7, VA2B3PN, VA2DVME, VA236DC, VA254MA, VA2696J, VA277EB, VA28C1Z,  VA29LPC, VA2B3PQ, VA2DVNX, VA23BWB,  VA254MC, VA2696L, VA27JJV, VA28C36, VA29PPY,  VA2BFSP, VA23BXM, VA254MD, VA269LV, VA27MQ3, VA28DVB, VA29S0E, VA2BHV6, VA23J1U,  VA2562G, VA26AGU, VA27RMG, VA28LVR, VA29S0F, VA2CEVY, VA23J4X, VA257LH, VA26E5P,  VA27SW9, VA28NFL, VA29SB3, VA2CPP0, VA23L21, VA25QDQ, VA26E5R, VA27V4Y, VA28NG1,  VA29UNG, VA2CXDR, VA23S64, VA25RHC, VA26K1N, VA27WDK, VA28SC8, VA29UPA, VA2D9X8, VA24R3X, VA25S3A, VA26K1R, VA27WDP, VA28XL0, VA29Z98, VA2DA0S,  VA23LXN,  VA23WY0, VA2446L, VA24AFN, VA24FA2, VA25DKB, VA23WXZ, VA23X94, VA249A6,  VA24EYN, VA2562K, VA23LXN, VA23WY0, VA2446L, VA24AFN, VA24FA2, VA25DKB, VA23WXZ, VA23X94, VA249A6, VA24EYN and VA2562K   b) PART NUMBER: 3389S-28 DBS Lead with StimLoc  LOTS #: VA25K4W, VA25CMZ and VA25DKD  c) PART NUMBER: 3389S-40 - DBS Lead with StimLoc        LOTS #:  VA21X0Y, VA24WXJ, VA260NN, VA27QE4, VA28NFM, VA29ZU0, VA2BE8A, VA2CQET, VA21ZJV, VA25101, VA26233, VA27RET, VA28SCE, VA2A3HK, VA2BEXC, VA2CQFM, VA21ZL1, VA259WX, VA2670U, VA27REU, VA28URD, VA2A6K7, VA2BF1G, VA2CQH2, VA227NQ, VA25B79, VA2672S, VA27SWB, VA28URE, VA2ACW4, VA2BFG0, VA2CRKW, VA228PU, VA25HSZ, VA26GGZ, VA27V8S,  VA28XHX, VA2ACW5, VA2BHHW, VA2D6WD, VA22C6L, VA25N4Y, VA26GPA, VA27WDE, VA28ZQ0,  VA2AD57, VA2BJEH, VA2D71G, VA22KF4, VA25N50, VA26KJ3, VA27ZA2, VA28ZQ2, VA2AD5G, VA2C8BG, VA2D730, VA22MXM, VA25N6D, VA26NWG, VA27ZRE, VA291YL, VA2AH9C, VA2CABX,  VA2D739, VA22TDL, VA25RSZ, VA26Q16, VA280V2, VA291YM, VA2AHHR , VA2CBQ0, VA2D73E, VA22V9R, VA25TBA, VA26Q6E, VA283SH, VA2924E, VA2AHNG, VA2CFBH, VA2DAZA, VA22VZB, VA25UBK, VA26R4H, VA2865T, VA2924F, VA2AHNM, VA2CJ4Z , VA2DAZT, VA22Y79, VA25UG1, VA26TK5, VA2893X, VA29LPD, VA2AHT7, VA2CK66, VA2DB2C, VA237AP, VA25VKR, VA26XGF, VA289WG, VA29LUC, VA2AR36, VA2CK8L, VA2DB2L, VA2382J, VA25VQD, VA26ZFV, VA289WH, VA29MUW, VA2B3SB, VA2CLRF, VA2DB2V, VA2382Y, VA25XC7, VA272ZP, VA28DN6, VA29PLU, VA2B3SC, VA2CN0F, VA2DBAU, VA2384E, VA25YHU, VA275D6, VA28E06, VA29PM8, VA2B7G5, VA2CN0H, VA2DUR8, VA239JK, VA25YHW, VA276MJ, VA28KWJ, VA29UB3, VA2BDS1, VA2CN7Z, VA2DUR9, VA23P6D, VA25YR5, VA27E9P, VA28LHR, VA29UPD, VA2BDSE, VA2CN86, VA2DURH, VA23S5Z, VA25ZJ3, VA27JJS, VA28LHU, VA29UPH, VA2BDSX, VA2CN8A, VA24PD4, VA25ZJ6, VA27K8D, VA28M21, VA29ZES, VA2BE44, VA2CNX0, VA24RVR, VA25ZUB, VA27NE2, VA28M22, VA29ZM2, VA2BE7W, VA2CNXG, VA24WXH, VA25ZWB, VA27PDB, VA28M9B, VA29ZSC, VA2BE86, VA2CPPV, VA23MM7, VA23TVY, VA240PB, VA24237, VA2493U, VA24EYM, VA24L0S VA25LHE, VA23S65, VA23WXW, VA240YK, VA2440E, VA2493V, VA24G61 VA24M5P, VA25PZU, VA23TFY, VA23X95, VA241H1, VA244QV, VA24A58, VA24G7S, VA25B78, VA25QSW, VA23TVT, VA23XYL, VA241NE, VA245W8, VA24AYZ, VA24GWZ and VA25CF3  d) PART NUMBER: 3391S-40 - DBS Lead with StimLoc   LOTS #: VA2391V, VA25B91, VA2AD6N, VA2BJWK, VA2DN50 and VA2DR23   e) PART NUMBER: 3550S-01 - Spare Parts Kit for StimLoc¿ Burr Hole Cover    LOTS #: 082300620, 082307020, 082307620, 082329819, 082332919, 082335119,  082335320, 82316820 and 82326919   f) PART NUMBER:  924256 - StimLoc Burr Hole Cover LOTS #: 082202020A, 082203820A, 082211120A, 082228819A, 082234520A, 082202121A,  082207920A, 082214120A, 082232319A, 082235019A and 082224219A  g) PART NUMBER: DB-5000 -StimLoc Support Clips LOTS #: 082104420"
    }
  ]
}