Moderate riskFDA DeviceNov 6, 2026Class II

Medtronic SmartSync app recalled for Bluetooth disconnection risk

Medtronic's CareLink SmartSync Device Manager App, a tablet-based platform used to program and check compatible Medtronic implanted cardiac devices, may lose its Bluetooth connection to its accessories. If this happens during a patient session, the device settings may be programmed incorrectly or incompletely, which may lead to harm.

From the FDA notice · Read the official notice ↗ · All Medtronic recalls

What to do

Check whether your app's serial number appears in the list in the recall notice.
The notice does not say how to get a remedy, so contact Medtronic for next steps before using the affected app.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: CareLink SmartSync Device Manager App, a tablet-based platform used to program and interrogate compatible Medtronic CIEDs, Product Number M01A02
Sold in: Nationwide
Made for: All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected: 38175 systems
Illnesses reported: None reported
Manufactured in: 8200 Coral Sea St Ne, Mounds View, Minnesota, United States
Classification: Class II
Recall number: Z-0361-2027

In the FDA's words

Description: CareLink SmartSync Device Manager App, a tablet-based platform used to program and interrogate compatible Medtronic CIEDs, Product Number M01A02 Bluetooth disconnections may occur between the device manager software and its associated accessories. Bluetooth disconnections during a SmartSync patient session may lead to harm due to undesirable or incomplete parameter programming. UDI-DI: NA; 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 GJ2KD063F7 GJ9YWDKQCV GJQMT4K3DT GL91WL5X7M GMK3JWNR94 GMKPJ67Y4P GN7N7K7XYM GN9216D3R4 GNPRYX0XWP GP24M66J3Y GPR6RPFCJ7 GQ0CV4CF0H GQ9VK1Q5L9 GXPG3JFMJX GY20FGY4CR GY46FPG6V0 H16VP6XV2T H39739V6QN H3QRQ33QY4 H40JWD94DP H41R97CY32 H5717KF97X H60XQTVYHF H79KM7VW7H H7JXKWTY72 H96J73HRX5 H9PK00DXPG HD7JWFXX6G HDHKC6MWXF HNW5L25VHC HPF0VMGJ9P HPR2DF7W6L HPWFDJMH4C HR9G9KJ20D HT9VP9QRH4 HV64G5W0H7 HW0WG7063M HW4WWH4G4V HW7TP7GCVH HYW5RV7MHP J191V6NC7L J1Y5C3YQ9P J22FPM725L J29324MYP1 J2CR2WMHC3 J3606DRWQ5 J36KQ100X2 J4F9P2VFNM J4FM6HYJVC J5R2252J54 J6DCFQKPQ6 J6P44HPQHQ J9PWC6JW6T JC4XV2YFX1 JCYD6591C2 JFQ23154XW JL6DVPYT65 JMY3YYX0JM JQ9TYX4DQ4 JQWVP7D726 JV947XXNMJ JVX5QJMGYN JWCYD09Q65 JXCQQRYP4Q K247DP7QHR K26QPK4FLK K2QQXCWXFD K2R6Y0FJWF K399W0XXLW K3WRYVY2L9 K4PV71RYGR K59MPM2626 K6QQT56X0X K725YXDXCT K7PHR6L9FM K9H7RX1Y4K KF7JVVMQDH KGFG4J2YJJ KH2VNJ07FR KJKXQJ2N7T KJTY47P09P KK6L4F2QMT KVCTV54ML2 KVG6P2C2CN KVWH0C65N4 KY2C5752WP L3R6FQVV6J L6TGCLG0HQ L70YH9FD60 L793LK2JGK L7FFQLH21W L7K7HQ5WG2 L7QDQ559KG L92RX12WX6 L9LG97R4TM LCDT65GWHG LD4YW295V2 LDY9PYKX93 LF3V6DV6NT LFT9V37W2J LNFDF0QNJ9 LQCPGXG1QX LTJ7FD24R9 M02446WFM3 M12M20W14V M70QKX77YL MD977JY0XM MFL245N23T MGQQWQ1CW5 MH9R3JT6YK MJYDHQGK14 MM22G09X77 MMW1DWYK16 MPYVQX17M7 MWF627WW62 MWPP6JK9HT MWQ0MJ9R91 MWYMVF6M5W N4LNPH44GW N5GQHFN63C N9W73D2W3M NC604QTD4K NF22JHCDK6 NH947TXNPC NJJXRQ914K NVY9C260XG NXDG9KM2Y6 NY6H9GNF97 P3W6DJP93J P70VF9DYXF P7P3V7X0RH P94CRW75WY P9755F74XY PCWX4NRWXV PG455CQTX3 PGL9KQYWM9 PH0JXRYX0J PH663J9QRP PN79L7V2WT PQ2WXH6WP3 PQ4RW2J2J0 PQHR4XC9N7 PX2GQXDXVK PXQQCP74Q4 Q6VWXPXJXK QF9YQM9PC2 QGJQ1G6XNW QLWRXK1GL2 QQK6CGWQ9F QQL2R9RF9X QRXM54QWTC QRXRMY460X QV33WCGFPM QX5MHJH9X5 QXMK4XF9H2 R1VV1Q5XX3 R23J57GKX7 R3W6QTPQ9W R4TJQN729X RH0C2PYN6P RHHK7KQV9W RJPWNWVQJF RQ4W4036KX RVY1Q27RGP RW16KH2WHQ TC3Q2X7HCQ TPXKFGYHWT TW79MF2HFD V3P57VVHD7 V56LQ6WNHR V6272KDY4G VJ99YYW3VK VQNFYQXJQ4 VQXK1H4QYP VTG7LR7Q0Y W077G7RCY4 W25M9TNFW9 WF4TGCRXNQ WKHG3H69GR WQFK3MKVHW WR4YQWDG34 WVVCY54HDH X13RW1CDFR X1XDT94R95 X2GXFKYCNW X40N6TVMCQ X63431WX7R X64M9YFX4H XHWR0Q2JRH XL6KMGJH6D XN64G710WD XVRXD95279 XX42F5XXLW Y946WJ1WNY YFLY0HWMM9 YFR7M0VXPM YH63JXDPFC YHHQQJPC21 YM71D70CVF YMCQDXRVF9 YN9V2Y6RN2 YNJL2X2VVJ YQD4PC72GH YQG53P9QLF YQNQH66YMG YVGQLGWF0W YWG3R61772 CHXM497GFX CYMVDW70H2 F3CGFXG9Q6 J65QNVWFY3 J6WC32G9FY JRVV17HPMV K69F62TVMW LTF9WXYHX4 LVP2RH4KWP M2W9RK4V5C MYC0XR7WJD P6K2CYNWJJ C2H330FH6N C2JYYPQXDK C4072PL47Y C4NJ4J1XD6 C7RYCHGLWD C9L4W37PYM C9R2Q490TL CFF7FLQVMC CJ7F14JC4P CKQWW4CQYW CQ30NRW6TT CQT602245L CTJJG3RD2Q CX2LQJ49GG CXQY6HW7TD CYHXKJQ6WD D226W907D1 D2CWWYTX91 D3H7V59P7Y D3KFWWXGCX DF231F7RN2 DWFHM400HT F0GJH6CWYH F4QKG33NHY F9XHV4KWX5 FT9G6M64PF FVJKFWQQPM FWVHYRPQR0 G609KXW3QK GD6V6Q3100 GFY43V32DJ GGXQFTXT95 GVX297JT26 H9KXTQXQK9 HQX9FHWXWR HX4D5P94WV HYWGWXF732 J3W9TD7247 J52VMRPFWC J66RJ4F7V1 J66V6W7GFP J6QHXJ0W0C JC4NPWQ59P JF3Y2H4NTH JG4F4652DQ JKWLY9GYKH JMT29JFPNY JQY3Y14R36 JR2XVQR96X JRVGWJVJ19 JVWWWMXGXQ JY3KQQY7WT JYD2Y0MD7D K33QV9G03M K49QGRWR2R K4LVHMW5XV KC7V4W5FX9 KCXM6RQLP6 KF6MWD2FGM KFW0WMWW5V KL61P6PTGG KN4MY5LQWC KT6HT0LGV4 L496XTT4DN L4XD3N4VG9 LF3HM6L7J9 LJWY4G966F LMW0Y7W26D M4NJ4MFM9M MFXJJC469Y MQ6LYJ3QH5 N4VFQ9VH6N P5F499GK07 P6FVQN4H3G P749DDH5MW PR94RYF4XM Q4
Hazard: Bluetooth disconnections may occur between the device manager software and its associated accessories. Bluetooth disconnections during a SmartSync patient session may lead to harm due to undesirable or incomplete parameter programming.

3 products in this recall

Medtronic SmartSync app, programmers recalled for Bluetooth disconnection risk

Medtronic is recalling 3 related products used to program and check Medtronic cardiac implantable devices: the CareLink SmartSync Device Manager App (M01A02), the Programmer 24970A, and the RF Head 24967 Patient Connector and RF Head 24967 EUR MKT. Bluetooth disconnections may occur between the device manager software and its accessories, and during a SmartSync patient session this may lead to undesirable or incomplete parameter programming that could cause harm. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

CareLink SmartSync Device Manager App, a tablet-based platform used to program and interrogate compatible Medtronic CIEDs, Product Number M01A02 (this page)
Z-0361-2027 · 38175 systems
PROGRAMMER 24970A, provides the analyzer and ECG hardware during device implant, invasive troubleshooting, and implanted device follow-up procedures, Produc…
Z-0362-2027 · 11301 units
RF HEAD 24967 PATIENT CONNECTOR and RF HEAD 24967 EUR MKT, communicates with Medtronic cardiac devices, Product Number 24967
Z-0363-2027 · 11741 untis