{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "188018", "product_res_number": "Z-2228-2021", "event_date_initiated": "2021-06-02", "event_date_created": "2021-08-06", "recall_status": "Open, Classified", "res_event_number": "88160", "product_code": "GXR", "k_numbers": [ "K001096" ], "product_description": "Medtronic StimLoc Burr Hole Cover, Part Numbers:\na) 3387S-40\nb) 3389S-28\nc) 3389S-40\nd) 3391S-40\ne) 3550S-01\nf) 924256\ng) DB-5000", "code_info": "a) PART NUMBER: 3387S-40 - DBS Lead with StimLoc\t\nLOTS # : VA21YUS, VA24RVV, VA25SDK, VA26Q2S, VA27X8H, VA2980G, VA29Z9A, VA2DA2Z, \nVA21ZJU, VA24S65, VA25WK1, VA26XP2, VA27ZRF, VA29814, VA2A5MJ, VA2DA5Y, VA21ZYP, \tVA24S66, VA2613V, VA26ZFU, VA281L5, VA2985H, VA2AK84, VA2DA9E, VA222L5, VA24SRF, \tVA261EL, VA275SC, VA2820Y, VA29BSM, VA2APV8, VA2DEKH, VA227E2, VA24UVS, VA263GC, \tVA275SD, VA282CS, VA29E09, VA2B3PB, VA2DVM9, VA22LDZ, VA24ZFG, VA26460, VA276GS,\tVA283SF, VA29LP7, VA2B3PN, VA2DVME, VA236DC, VA254MA, VA2696J, VA277EB, VA28C1Z, \tVA29LPC, VA2B3PQ, VA2DVNX, VA23BWB, \tVA254MC, VA2696L, VA27JJV, VA28C36, VA29PPY, \tVA2BFSP, VA23BXM, VA254MD, VA269LV, VA27MQ3, VA28DVB, VA29S0E, VA2BHV6, VA23J1U, \tVA2562G, VA26AGU, VA27RMG, VA28LVR, VA29S0F, VA2CEVY, VA23J4X, VA257LH, VA26E5P, \tVA27SW9, VA28NFL, VA29SB3, VA2CPP0, VA23L21, VA25QDQ, VA26E5R, VA27V4Y, VA28NG1, \tVA29UNG,\tVA2CXDR, VA23S64, VA25RHC, VA26K1N, VA27WDK, VA28SC8, VA29UPA, VA2D9X8, VA24R3X, VA25S3A, VA26K1R, VA27WDP, VA28XL0, VA29Z98, VA2DA0S, \nVA23LXN, \tVA23WY0, VA2446L, VA24AFN, VA24FA2, VA25DKB, VA23WXZ, VA23X94, VA249A6, \tVA24EYN, VA2562K, VA23LXN, VA23WY0, VA2446L, VA24AFN, VA24FA2, VA25DKB, VA23WXZ,\tVA23X94, VA249A6, VA24EYN and VA2562K\t\n\nb) PART NUMBER: 3389S-28 DBS Lead with StimLoc\t\nLOTS #: VA25K4W, VA25CMZ and VA25DKD\n\nc) PART NUMBER: 3389S-40 - DBS Lead with StimLoc\t\t\t\t\t\t\t\nLOTS #: 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,\tVA27SWB, VA28URE, VA2ACW4, VA2BFG0, VA2CRKW, VA228PU,\tVA25HSZ, VA26GGZ, VA27V8S, \tVA28XHX, VA2ACW5, VA2BHHW, VA2D6WD, VA22C6L, VA25N4Y, VA26GPA, VA27WDE, VA28ZQ0, \tVA2AD57, VA2BJEH, VA2D71G, VA22KF4, VA25N50, VA26KJ3, VA27ZA2, VA28ZQ2, VA2AD5G, VA2C8BG, VA2D730, VA22MXM, VA25N6D, VA26NWG, VA27ZRE, VA291YL, VA2AH9C, VA2CABX, \tVA2D739, VA22TDL, VA25RSZ, VA26Q16, VA280V2, VA291YM, VA2AHHR\t, VA2CBQ0, VA2D73E, VA22V9R, VA25TBA, VA26Q6E, VA283SH, VA2924E, VA2AHNG, VA2CFBH, VA2DAZA, VA22VZB, VA25UBK, VA26R4H, VA2865T, VA2924F, VA2AHNM, VA2CJ4Z\t, 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,\tVA276MJ,\tVA28KWJ,\tVA29UB3,\tVA2BDS1,\tVA2CN7Z,\tVA2DUR9, VA23P6D,\tVA25YR5,\tVA27E9P,\tVA28LHR,\tVA29UPD,\tVA2BDSE,\tVA2CN86,\tVA2DURH, VA23S5Z,\tVA25ZJ3,\tVA27JJS,\tVA28LHU,\tVA29UPH,\tVA2BDSX,\tVA2CN8A,\tVA24PD4,\tVA25ZJ6,\tVA27K8D,\tVA28M21,\tVA29ZES,\tVA2BE44,\tVA2CNX0,\tVA24RVR,\tVA25ZUB,\tVA27NE2,\tVA28M22,\tVA29ZM2,\tVA2BE7W,\tVA2CNXG,\tVA24WXH,\tVA25ZWB,\tVA27PDB,\tVA28M9B,\tVA29ZSC,\tVA2BE86,\tVA2CPPV,\tVA23MM7,\tVA23TVY,\tVA240PB,\tVA24237,\tVA2493U,\tVA24EYM,\tVA24L0S\tVA25LHE, VA23S65,\tVA23WXW, VA240YK,\tVA2440E,\tVA2493V,\tVA24G61\tVA24M5P,\tVA25PZU, VA23TFY,\tVA23X95,\tVA241H1,\tVA244QV,\tVA24A58,\tVA24G7S,\tVA25B78,\tVA25QSW, VA23TVT,\tVA23XYL,\tVA241NE,\tVA245W8,\tVA24AYZ,\tVA24GWZ and VA25CF3\n\nd) PART NUMBER: 3391S-40 - DBS Lead with StimLoc\t\t\nLOTS #: VA2391V, VA25B91, VA2AD6N, VA2BJWK, VA2DN50 and VA2DR23\n\n\ne) PART NUMBER: 3550S-01 - Spare Parts Kit for StimLoc¿ Burr Hole Cover\t\t\t\nLOTS #: 082300620, 082307020, 082307620, 082329819, 082332919, 082335119, \t082335320, 82316820 and 82326919\n\t\nf) PART NUMBER: 924256 - StimLoc Burr Hole Cover\nLOTS #: 082202020A, 082203820A, 082211120A, 082228819A, 082234520A, 082202121A, \t082207920A, 082214120A, 082232319A, 082235019A and 082224219A\n\ng) PART NUMBER: DB-5000 -StimLoc Support Clips\nLOTS #: 082104420", "firm_fei_number": "2182207", "recalling_firm": "Medtronic Neuromodulation", "address_1": "7000 Central Ave Ne", "city": "Minneapolis", "state": "MN", "postal_code": "55432-3568", "additional_info_contact": "Medtronic Technical Services \n800-707-0933", "reason_for_recall": "Excess nylon flash on the clip.", "root_cause_description": "Process control", "action": "On June 2,2021 the firm sent letter with the following information: \n\nDear Healthcare Professional,\nMedtronic is voluntarily recalling specific lots of the StimLoc\" Burr Hole Cover due to a manufacturing issue resulting in excess nylon flash on the clip. Please review the information contained in this letter, quarantine any affected product (see Attachment A for list of affected lot numbers) in your inventory for return to Medtronic, and sign and return the customer confirmation form included with this letter.\n\nMedtronic email at RS.NeuAdverseEventReporting@Medtronic.com or Medtronic Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.", "product_quantity": "15,192", "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, \nWV and Hawaii", "openfda": { "k_number": [ "K123163", "K960656", "K041611", "K002334", "K123633", "K913490", "K221606", "K140309", "K091692", "K141368", "K181382", "K160739", "K130309", "K031654", "K040080", "K152342", "K132044", "K071138", "K001096", "K181539", "K253447", "K853367", "K101235", "K042986", "K240137", "K021408", "K192162", "K010361", "K192310" ], "registration_number": [ "3010155648", "3008974316", "3011423165", "2027754", "1218882", "3007923096", "3004719693", "2011171", "2182207", "8010177", "2916714", "2032521", "3019807891", "1649518", "3004464325", "1721676", "2024024", "1054811", "3004426659", "2183744", "9610612", "1928237", "9612501", "3004049923", "2027148", "3008791302", "3003477135", "3007738812", "3011530718", "3017884860", "3008812560", "3013340866", "1032347", "2029447", "3015440604", "3010191069", "3034676720", "8030965", "1000606483", "3018094310", "1627487", "3005972619", "3009417901", "3015399803", "3014937101", "1825034", "3010178296", "1226425", "9610921", "3008868758", "3015531529", "8043792" ], "fei_number": [ "3010155648", "3008974316", "3002808269", "3011423165", "2027754", "1218882", "3007923096", "3004719693", "2011171", "3002806315", "2182207", "2916714", "3019807891", "3003495548", "3002806724", "3001236277", "3004464325", "1721676", "2024024", "3004426659", "2183744", "1928237", "3004049923", "2027148", "3008791302", "3003477135", "1000518793", "3007738812", "3011530718", "3017884860", "3008812560", "3013340866", "1032347", "3015440604", "3003110073", "3010191069", "3034676720", "1000606483", "3018094310", "1627487", "3005972619", "3009417901", "3002807305", "3015399803", "3014937101", "1825034", "3003574398", "3003018882", "1000114185", "3008868758", "3015531529", "3002821504" ], "device_name": "Cover, Burr Hole", "medical_specialty_description": "Neurology", "regulation_number": "882.5250", "device_class": "2" } } ] }