- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.
- Affected products (lot / model / serial)
- 978A128 UDI-DI 00763000203603 Lots VA27EGG VA27EGJ VA27EGK VA27FKV VA27FKW VA27FKX VA27GAB VA27GAC VA27GAD VA27GAE VA27GAF VA27GAG VA27GVY VA27GXC VA27GXD VA27GXF VA27HLS VA27HLT VA27HLU VA27HLV VA27K2T VA27NK1 VA27NLY VA27QTZ VA27QUA VA27QUF VA27QUP VA27QUR VA27WZN VA27X01 VA27YM3 VA27YM4 VA27YMC VA27YMD VA27YMF VA27YMJ VA282HH VA282J1 VA282J8 VA282JA VA282JY VA282K0 VA282KA VA282KG VA284XZ VA2868L VA2868M VA2868P VA2868Q VA286JC VA286K5 VA286MA VA287A7 VA287AA VA287DC VA287DH VA287TD VA287X3 VA2883C VA2883E VA28845 VA2884S VA28AXJ VA28AXK VA28B2T VA28B3Q VA28B5Z VA28EQ9 VA28ETU VA28EUA VA28EUK VA28EVN VA28GUJ VA28H21 VA28H22 VA28H9T VA28H9Z VA28L7U VA28L7V VA28L7W VA28LBA VA28LBD VA28LBF VA28PRE VA28PRG VA28PRH VA28PS8 VA28PUE VA28PVK VA28QHU VA28QHV VA28QHW VA28QNK VA28QPT VA28QPU VA28U5G VA28U5J VA28U5K VA28V6V VA28V71 VA28V77 VA28V79 VA28V7A VA28V7L VA28XDH VA28XDJ VA290PU VA290PV VA290PY VA290PZ VA290Q0 VA290S5 VA297UZ VA297VE VA297VU VA298JA VA298JF VA2990B VA299MT VA29ASB VA29BW5 VA29BX3 VA29BX5 VA29BX6 VA29D8Z VA29D93 VA29D97 VA29D98 VA29D99 VA29ED5 VA29ED6 VA29ED7 VA29ED8 VA29ED9 VA29EDB VA29EHD VA29EHE VA29EN5 VA29FTM VA29FTN VA29FTQ VA29FTS VA29FTT VA29FTU VA29FV3 VA29GYL VA29GYM VA29GYN VA29GYP VA29GYQ VA29J36 VA29J37 VA29J38 VA29K6E VA29K6G VA29K6H VA29K6J VA29K6L VA29LER VA29LET VA29LEU VA29LHU VA29MHS VA29RKQ VA29RKR VA29RL0 VA29RVS VA29SLG VA29U3F VA29U3G VA29VGP VA2A15H VA2A15J VA2A15K VA2A16H VA2A16L VA2A16M VA2A16N VA2A7L1 VA2A7L2 VA2A98D VA2A98E VA2A98F VA2A98G VA2AAUK VA2AAUL VA2AAUN VA2AAUP VA2ADDK VA2AE7E VA2AGD0 VA2AGD1 VA2AGD2 VA2AGD3 VA2AGD4 VA2AGEZ VA2AH78 VA2AHNP VA2AHZZ VA2AJ00 VA2AJ01 VA2AJ03 VA2AJ11 VA2AJ1D VA2AJ1E VA2ALYL VA2ALYM VA2ALYV VA2ALYW VA2ALYX VA2ALYY VA2ALYZ VA2ALZ0 VA2ANFH VA2ANFJ VA2ANFK VA2ANFL VA2ANFP VA2ANFQ VA2AS15 VA2AS16 VA2AS17 VA2AS40 VA2AYAR VA2B6WG VA2B6WH VA2B6WJ VA2B7YF VA2B7YK VA2B7YL VA2B7YM VA2B7YN VA2B7YP VA2B7YQ VA2B9NH VA2B9Y7 VA2B9Y8 VA2B9Y9 VA2B9YA VA2B9YB VA2BA07 VA2BAKM VA2BARD VA2BARM VA2BASK VA2BAST VA2BC27 VA2BFJU VA2BH6Z VA2BH70 VA2BH72 VA2BH73 VA2BH75 VA2BKPW VA2BM6T VA2BN5F VA2BN5L VA2BN5N VA2BN5R VA2BNLL VA2BNP7 VA2BNPK VA2BNPS VA2BQ9Q VA2BT24 VA2BT2Q VA2BT2Y VA2BT30 VA2BT31 VA2BT3W VA2BUTF VA2BUTM VA2BVSV VA2BVTA VA2BVX3 VA2BVX7 VA2BVXD VA2BVXQ VA2BVXX VA2BVY8 VA2BWRU VA2BXTN VA2BXU6 VA2BXUC VA2BXUJ VA2BZTT VA2BZTW VA2BZU1 VA2BZU4 VA2BZVK VA2BZVR VA2BZVU VA2BZVV VA2BZVX VA2C1FP VA2C1GD VA2C1GE VA2C1HV VA2C1HX VA2C1YK VA2C23C VA2C25J VA2C2AA VA2C2BN VA2C2C4 VA2C2CV VA2C2DZ VA2C2XF VA2C3MY VA2CAZ1 VA2CBWD VA2CBWG VA2CBWW VA2CC9M VA2CCAZ VA2CCQT VA2CCW3 VA2CCXM VA2CCY4 VA2CCYT VA2CCYY VA2CCZX VA2CDY5 VA2CE0R VA2CE17 VA2CE1K VA2CEEV VA2CEFA VA2CERU VA2CERY VA2CG7L VA2CG8K VA2CG8R VA2CGSS VA2CLVF VA2CLVL VA2CM1A VA2CM2K VA2CM4K VA2CN4W VA2CN59 VA2CN5Y VA2CN62 VA2CN69 VA2CN6E VA2CQTX VA2CTWB VA2CTWC VA2CTX0 VA2CTX6 VA2CTXA VA2CTXB VA2CU17 VA2CVWY VA2CVX3 VA2CVX7 VA2CVXF VA2CVXU VA2CW4J VA2CW4L VA2CW4N VA2CW4R VA2CWPE VA2CWPP VA2CWQ2 VA2CWW6 VA2CWWE VA2CWWM VA2CWX8 VA2CWXB VA2CWXQ VA2CWXS VA2CWY0 VA2CXPH VA2D0YC VA2D0YU VA2D1PN VA2D1PS VA2D1PY VA2D2L0 VA2D36R VA2D36X VA2D37N VA2D3CG VA2D3DZ VA2D3EQ VA2D3EX VA2D3F5 VA2D3F7 VA2D3FE VA2D3G8 VA2D3GG VA2D3M0 VA2D3M7 VA2D4DE VA2D4DP
- Units affected
- 94,441 (US); 60,488 (OUS)
- Distribution pattern
- Worldwide distribution - US Nationwide and territory of Puerto Rico. The countries of Brazil, Colombia, Chile, Canada, Japan, New Zealand, Australia, United Kingdom, Switzerland, Sweden, Spain, Portugal, Italy, Israel, Germany, France, Finland, Canary Islands, Belgium, Austria, Norway, Northern Ireland, Netherlands, Iceland, Denmark, South Africa, Turkey, Slovakia, Saudi Arabia, Poland, Hungary, United Arab Emirates (UAE), Kuwait, Greece.
- Firm location
- Minneapolis, MN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0266-2027
- Recall initiated
- September 8, 2026
- FDA classification date
- October 22, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99949
- Last updated on HTM Vibe
- November 3, 2026
