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Home › FDA recalls › InterStim Percutaneous Extensions EXT 3560022 ISTM II PE
CLASS II · ModerateFDA

Medtronic Neuromodulation recalls InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030

📅 Sep 8, 2026 · 📍 Nationwide
Recalling company
Medtronic Neuromodulation
Product
InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Reason
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Sep 8, 2026
Reported
Oct 28, 2026
Distribution
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.
Status
Ongoing
Quantity
56,331 (US); 40,211 (OUS)
Lot / codes
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
Company location
Minneapolis, MN
Recall type
Voluntary: Firm initiated
Recall number
Z-0267-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0267-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.