FDA Medical devices recall ·
CareLink SmartSync Device Manager App, Model M01A02, Pulse generator… recall
- Recall number
- Z-0304-2027
- Date
- (initiated September 24, 2026)
- Company / brand
- Medtronic, Inc.
8200 Coral Sea St Ne, Mounds View, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 38115 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
Why was it recalled?
Software problem has the potential for an inaccurate displayed longevity estimate.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, GJ2KD063F
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0304-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.