- 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)
- 3560022 UDI-DI 00763000203894 Lots VA24HE7 VA24R5J VA24TXT VA24UYB VA24WJE VA24WJF VA250XH VA25144 VA2515A VA25TEF VA25TEH VA25TEJ VA25TEL VA26A7F VA26AJA VA26AJB VA26AKS VA26AKT VA26AKU VA26AKV VA26C4T VA26CB1 VA26CB2 VA26EHL VA26EHN VA26EHP VA2725R VA2725S VA2726H VA2726J VA2728H VA2728K VA2728L VA275QE VA2760F VA277W0 VA277W1 VA27C85 VA27C86 VA27CCG VA27CEE VA27D4B VA27D62 VA27D63 VA27KEH VA27KGX VA27KHG VA27KHH VA27KHJ VA27KHK VA27KHL VA27NS0 VA27NSC VA27NSG VA27NSH VA27NSJ VA27NSL VA27ST1 VA27ST2 VA27UGK VA27UGL VA27UXN VA27UXP VA27VDZ VA27VED VA27VEE VA27VEF VA27VJF VA27VJG VA27VJJ VA27VWY VA27Y21 VA27Y22 VA27YF8 VA27YFG VA280D1 VA280E6 VA280LQ VA2848G VA28499 VA284MR VA284PJ VA284S3 VA286PS VA286PT VA2872W VA28AQH VA28BDU VA28BEW VA28BR6 VA28BR7 VA28DZR VA28E02 VA28EC2 VA28EC3 VA28GE3 VA28HC2 VA28HM9 VA28HSG VA28J1R VA28J1S VA28K8K VA28MHH VA28MHS VA28MYN VA28N0Y VA28N15 VA28N1R VA28T7D VA28T7F VA28TSM VA28TSP VA28UE7 VA28UHR VA28UHY VA28Z99 VA28ZJ5 VA28ZMP VA2976F VA297CK VA297CR VA297PV VA2990L VA29939 VA299J7 VA299J8 VA29EQE VA29EQF VA29EQG VA29EQJ VA29FSC VA29FSD VA29FSS VA29G5U VA29G94 VA29GKR VA29HCQ VA29HCU VA29HM5 VA29HM6 VA29N97 VA29QAK VA29QAL VA29QBK VA29QBL VA29QCE VA29QUW VA29QUZ VA29QVN VA29S6N VA29S6Q VA29SAV VA29SDN VA29SEY VA29SEZ VA29SF4 VA29SF5 VA29SYJ VA29Y62 VA29Y63 VA29YGH VA29YGJ VA29YKY VA29YW5 VA29Z8P VA29Z8Q VA29ZEG VA29ZN3 VA29ZSA VA29ZU3 VA29ZU4 VA29ZUG VA2A2Z3 VA2A5JQ VA2A5MK VA2A6GU VA2A6GY VA2A6L5 VA2A73R VA2A73U VA2A7EC VA2A7EF VA2A7HW VA2AEKR VA2AEM9 VA2AEWP VA2ALQ9 VA2ALUD VA2ALV0 VA2ALVA VA2ALW5 VA2APNN VA2APQA VA2APSH VA2APSU VA2ARAX VA2ARCA VA2ARCT VA2AYRR VA2AYRU VA2AYZ3 VA2AZ0W VA2AZ7J VA2AZ7R VA2B6PX VA2B8WD VA2B8WE VA2B8XZ VA2B8ZN VA2BBDN VA2BBDQ VA2BBT6 VA2BBU0 VA2BBWC VA2BBZM VA2BD21 VA2BDCD VA2BDCE VA2BHB0 VA2BHB9 VA2BHCD VA2BHCF VA2BHDU VA2BHDX VA2BHJN VA2BHPH VA2BHPK VA2BHPR VA2BUNB VA2BUNP VA2BUSW VA2BUVT VA2BXXB VA2BY1R VA2BY2N VA2BY4M VA2C4A9 VA2C4JZ VA2C582 VA2C585 VA2C7JX VA2C7LT VA2C7SB VA2CCJ0 VA2CCJ1 VA2CCJK VA2CCJL VA2CCJM VA2CCJN VA2CCJP VA2CCJR VA2CH8Y VA2CHC0 VA2CHET VA2CM6R VA2CM9W VA2CMA3 VA2CMAG VA2CMAL VA2CN36 VA2CPWP VA2CQ0U VA2CQ0Z VA2CQ1G VA2CQ23 VA2CQ2A VA2CSVR VA2CSW9 VA2CSWG VA2CSX2 VA2CT5M VA2CUN8 VA2CVB8 VA2CW13 VA2CZSU VA2CZSV VA2CZSY VA2CZT4 VA2D4PR VA2D4Q5 VA2D4QJ VA2D4QM VA2D4Z4 VA2D4ZU VA2D657 VA2D658 VA2D659 VA2D65A VA2D65B VA2D8B5 VA2DDCK VA2DDCU VA2DDD8 VA2DDDG VA2DDDT VA2DP4Z VA2DPAJ VA2DPCV VA2DPF5 VA2DPNR VA2DVAY VA2DVB5 VA2DVBA VA2DVBF VA2DVDA VA2DVP5 VA2DVPQ VA2E1PW VA2E1PY VA2E1Q1 VA2E1QE VA2E2EK VA2E491 VA2E494 VA2E4A5 VA2E4AC VA2ECQY VA2ECRM VA2ECS4 VA2ECTK VA2ECTM VA2ECTV VA2EGXE VA2EGXJ VA2EGXK VA2EGZ4 VA2EHT8 VA2EMDT VA2EME1 VA2EME9 VA2EMEP VA2EMF5 VA2EMFB VA2EMM1 VA2EMN8 VA2ENF9 VA2ENH4 VA2ENH7 VA2ENJG VA2ENJQ VA2ENJT VA2ENJV VA2ENKX VA2ENW3 VA2EP8C VA2ESRT VA2ESSH VA2ESSW VA2ESTM VA2ESTV VA2ESU0 VA2ESUA VA2ESUK VA2EYMM VA2EYNF VA2EYQQ VA2EYRB VA2F0TM VA2F0U6 VA2F0UV VA2F1B5 VA2F1G2 VA2F1G6 VA2F1GQ VA2F1HH VA2F1XE VA2F1XY VA2F1ZF VA2F202 VA2F21Q VA2F222 VA2F259 VA2F25E VA2F25V VA2F38C VA2F38K VA2F38T VA2F3DE VA2F3ET VA2F3FG VA2F3FX VA2F3G6 VA2F3K6 VA2F4BJ VA2F4E5 VA2F4KD VA2F4M7 VA2F4MY VA2FBYT VA2FBYW VA2FBZJ VA2FBZZ VA2FC00 VA2FC0H VA2FC0T VA2FPRU
- Units affected
- 56,331 (US); 40,211 (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-0267-2027
- 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
