Z-0304-2027 Class II Ongoing

Recalled by Medtronic, Inc. — Mounds View, MN

FDA device recall Z-0304-2027 was initiated by Medtronic, Inc. on Sep 24, 2026 and is designated Class II. Reason for recall: Software problem has the potential for an inaccurate displayed longevity estimate. The recall status is ongoing. Affected quantity: 38115 units.

Recall details

Product Type
Devices
Report Date
Nov 4, 2026
Initiation Date
Sep 24, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
38115 units

Product description

CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable

Reason for recall

Software problem has the potential for an inaccurate displayed longevity estimate.

Distribution pattern

Worldwide distribution.

Code information

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, 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Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0304-2027
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for Z-0304-2027. Report a data issue: hello@regdatalab.com.