Medtronic Neuromodulation 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
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, 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
Products Sold
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
Medtronic Neuromodulation is recalling Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) due to Excess nylon flash on the clip.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Excess nylon flash on the clip.
Recommended Action
Per FDA guidance
On June 2,2021 the firm sent letter with the following information: Dear Healthcare Professional, Medtronic 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. Medtronic email at RS.NeuAdverseEventReporting@Medtronic.com or Medtronic Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, DC
Page updated: Jan 10, 2026