Medtronic, Inc. recalls CareLink SmartSync Device Manager App
- Recalling company
- Medtronic, Inc.
- Product
- CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
- Reason
- Software problem has the potential for an inaccurate displayed longevity estimate.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 24, 2026
- Reported
- Nov 4, 2026
- Distribution
- Worldwide distribution.
- Status
- Ongoing
- Quantity
- 38115 units
- Lot / codes
- GTIN none, Serial Numbers: C2TM4QV0XC, DL269KH953, DVP79R6KV6, FDG69FQX19, FHHG9CHX3H, FVFVMVPK7N, FVQYCR34T1, FYJPFH6099, G19LC9X7J7, G2VQP97D2J, GR4R69G4VN, GW7TFH7HQ0, GX44D2GDP4, H3G0Q6W9T7, H3QGWTYW42, H9GX6NHL45, HD2104VHK2, HD972G7JFV, HK212M19PD, HPH6FQFHF9, J4G16FXW05, JGYXLTCXLW, K6HTFXLW2T, KD0MV7CVQG, KQL96W3WGF, MGF4DJCVFL, Q76YQPKJQK, QXGQV69765, RH1XG26WGV, V669K664R6, X2XDNVV5CF, C2TR7WKTWW, C44L16FCW7, C52X07MXR7, C5Y6H49KH6, C69TG9WDJV, C69W9N6PWF, C6VT6QX05N, C9W7NX7X11, CFQT0F4N2T, CH02T6FTFJ, CJ2VX4PCQT, CJF6VNT3HT, CJR4Y6920X, CM44FWL9G7, CP63R629G3, CQ94K67LJF, CW3KFX02JG, CW7XHL6MPY, CW9LQ9593X, CWJX3439G5, CWNW7QK7YW, CWR0W7J4VL, CWRR649J63, CWVJ60WDCC, CWVXWHWG17, CWYMJQKVDN, CX99YN7PL2, CXGCY70L60, CXWJLXQYX6, D04T9VT46M, D0JFR44TD2, D4070M21J1, D494VRK60H, D617Y162PJ, D6VF5YXXH1, D70KX7QJ22, D723GV1WQW, D7K79L70F6, D7LG73X9JW, D7RJ2T9KC9, D96NK032FY, DH94DT62V4, DTD172G4YP, DY63799N29, F062YWR7V3, F2NL42C2MM, F3WV20DVTJ, F3Y0R2YGQT, F4KNXN3609, F4XWWJ5TXM, F5VX9GHG0W, F67W79C3FH, F67XVY2M27, F6C6667WJ6, F6P9MNVDYR, F7NP73CN7H, F7NYPL2MKC, FD90MH6YVY, FH497W575J, FHN2F9F614, FHYYG7FDJP, FK6JX9D61J, FKPFXKGWC4, FLYF7YXF69, FMHXCDJJMG, FNXQ10D4RW, FPQT4VT2JN, FT6HQK60D7, FVJG2N26J1, FWRJF0VMR9, FWVYMJH9TR, FX1Y74DLC4, FX2337J9GQ, FX76D726VH, FY4016742W, FY90KH799T, FYD90QM3W0, G07VQ2G2XK, G0HK4Q75WV, G170JGHLQL, G1C96DL6C9, G1CF04Q3H9, G2DT932HNY, G2PX4QHHG3, G46K22XXN9, G4TYJ0QM7X, G4WCV2RYR7, G5X4CXQYR3, G6J29221WX, G9C979CX95, GH4V46FGPG, GJ2KD063
- Company location
- Mounds View, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0304-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0304-2027 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.