CLASS II ONGOING Device recall · Reported 18 Aug 2021 · FDA Enforcement Report
Medtronic StimLoc Burr Hole Cover, Part Numbers recalled
Medtronic Neuromodulation is recalling Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d), distributed in 47 states. The recall was initiated on 2 Jun 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2228-2021
- FDA event ID
- 88160
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jun 2021
- FDA classified
- 6 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 Jun 2021 | Recall initiated by company | |
| 6 Aug 2021 | Classified by FDA | +65 days |
| 18 Aug 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Excess nylon flash on the clip.
Product as listed by the FDA
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
Where it was distributed
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
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Why was it recalled?
Excess nylon flash on the clip.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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