FDA Device recall Z-2228-2021
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
- FDA Device
- Class II
- ongoing
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of 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 by Medtronic Neuromodulation, citing excess nylon flash on the clip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2228-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-02 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | 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, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
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
Reason
Excess nylon flash on the clip.
Identifiers
| code_info | a) PART NUMBER: 3387S-40 - DBS Lead with StimLoc LOTS # : VA21YUS, VA24RVV, VA25SDK, VA26Q2S, VA27X8H, VA2980G, VA29Z9…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, VA29 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2228-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.