Moderate riskFDA DeviceNov 6, 2026Class II

Medtronic programmer 24970A recalled for Bluetooth disconnection risk

Medtronic's PROGRAMMER 24970A provides analyzer and ECG hardware during device implant, invasive troubleshooting, and implanted device follow-up procedures. Bluetooth disconnections may occur between the device manager software and its accessories. A disconnection during a SmartSync patient session may lead to harm from undesirable or incomplete parameter programming.

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

What to do

Clinicians: check whether your programmer matches the UDI-DI or serial numbers listed in the notice.
Contact Medtronic about affected units before using them for SmartSync patient sessions.
The notice doesn't specify a remedy; contact Medtronic for next steps.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: PROGRAMMER 24970A, provides the analyzer and ECG hardware during device implant, invasive troubleshooting, and implanted device follow-up procedures, Product Number 24970A
Sold in: Nationwide
Made for: All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected: 11301 units
Illnesses reported: None reported
Manufactured in: 8200 Coral Sea St Ne, Mounds View, Minnesota, United States
Classification: Class II
Recall number: Z-0362-2027

In the FDA's words

Description: PROGRAMMER 24970A, provides the analyzer and ECG hardware during device implant, invasive troubleshooting, and implanted device follow-up procedures, Product Number 24970A 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: 00763000044688, 00643169957657, 00763000201333, 00763000201289, 00763000201296, 00763000203979, 00763000288051, 00763000203962, 00763000317782, 00763000317768, 00763000397821, 00763000424343, 00763000424299, 00763000518981, 00763000518967, 00763000688400, 00763000688455, 00763000688462, 00763000825416, 00763000688424, 00763000850234, 00763000850241, 00763000688448, 00763000876265, 00763000876272, 00763000967192; Serial Numbers: SPM001252A SPM001274A SPM001303A SPM001309A SPM001317A SPM001321A SPM001323A SPM001332A SPM001375A SPM001505A SPM001554A SPM001565A SPM001576A SPM001582A SPM001585A SPM001588A SPM001589A SPM001611A SPM001619A SPM001624A SPM001634A SPM001645A SPM001657A SPM001660A SPM001673A SPM001686A SPM001687A SPM001690A SPM001698A SPM001712A SPM001713A SPM001753A SPM001769A SPM001793A SPM001812A SPM001820A SPM001972A SPM001978A SPM001989A SPM001995A SPM002001A SPM002002A SPM002003A SPM002004A SPM002006A SPM002009A SPM002011A SPM002012A SPM002013A SPM002014A SPM002015A SPM002067A SPM002088A SPM002092A SPM002097A SPM002106A SPM002107A SPM002111A SPM002112A SPM002115A SPM002118A SPM002121A SPM002122A SPM002124A SPM002128A SPM002153A SPM002248A SPM002293A SPM002356A SPM002367A SPM002441A SPM002464A SPM002467A SPM002469A SPM002472A SPM002538A SPM002539A SPM002542A SPM002576A SPM002578A SPM002585A SPM002587A SPM002618A SPM002622A SPM002646A SPM002651A SPM002672A SPM002684A SPM002697A SPM002702A SPM002703A SPM002716A SPM002720A SPM002741A SPM002742A SPM002744A SPM002921A SPM002929A SPM002931A SPM002937A SPM002941A SPM002942A SPM002954A SPM002956A SPM002964A SPM002991A SPM003001A SPM003005A SPM003009A SPM003015A SPM003020A SPM003023A SPM003033A SPM003064A SPM003071A SPM003076A SPM003077A SPM003080A SPM003081A SPM003090A SPM003097A SPM003104A SPM003107A SPM003114A SPM003115A SPM003116A SPM003120A SPM003138A SPM003140A SPM003430A SPM003465A SPM003472A SPM003475A SPM003515A SPM003517A SPM003534A SPM003546A SPM003547A SPM003556A SPM003566A SPM003568A SPM003569A SPM003570A SPM003578A SPM003585A SPM003596A SPM003607A SPM003608A SPM003609A SPM003697A SPM003701A SPM003737A SPM003971A SPM004250A SPM004403A SPM004509A SPM004537A SPM004541A SPM004542A SPM004546A SPM004550A SPM004555A SPM004578A SPM004580A SPM004585A SPM004591A SPM004594A SPM004595A SPM004621A SPM004670A SPM004682A SPM004684A SPM004692A SPM004694A SPM004700A SPM004705A SPM004712A SPM004717A SPM004752A SPM004753A SPM004754A SPM004773A SPM004784A SPM004785A SPM004795A SPM004800A SPM004802A SPM002024A SPM001459A SPM001461A SPM002410A SPM002415A SPM002424A SPM002736A SPM002756A SPM002796A SPM002883A SPM002885A SPM003141A SPM003213A SPM003220A SPM003318A SPM003339A SPM003491A SPM003818A SPM003843A SPM003844A SPM003993A SPM004052A SPM004055A SPM004178A SPM004501A SPM004507A SPM004508A SPM004512A SPM004520A SPM004522A SPM004524A SPM004527A SPM004528A SPM004529A SPM004536A SPM004548A SPM004654A SPM004735A SPM004840A SPM004842A SPM004843A SPM004846A SPM004847A SPM004849A SPM004851A SPM004852A SPM004854A SPM004855A SPM004856A SPM004858A SPM004860A SPM004862A SPM004863A SPM004864A SPM004867A SPM004868A SPM004871A SPM004873A SPM004875A SPM004876A SPM004877A SPM004878A SPM004879A SPM004884A SPM004886A SPM004889A SPM004890A SPM004894A SPM004895A SPM004896A SPM004897A SPM004902A SPM004907A SPM004908A SPM004910A SPM003795A SPM004931A SPM004939A SPM004963A SPM004986A SPM004987A SPM004988A SPM004989A SPM004990A SPM004991A SPM004992A SPM004994A SPM004995A SPM004996A SPM004997A SPM004999A SPM005002A SPM005008A SPM005013A SPM005021A SPM005023A SPM005025A SPM005026A SPM005028A SPM005029A SPM005034A SPM005035A SPM005036A SPM005039A SPM005042A SPM005043A SPM005045A SPM005046A SPM005047A SPM005051A SPM005054A SPM005055A SPM005060A SPM005061A SPM005063A SPM005064A SPM005065A SPM005066A SPM005069A SPM005077A SPM005078A SPM005080A SPM005081A SPM005082A SPM005087A SPM005088A SPM005089A SPM005091A SPM005095A SPM005098A SPM005116A SPM005140A SPM005142A SPM005143A SPM005156A SPM005157A SPM005158A SPM005161A SPM005168A SPM005175A SPM005177A SPM005178A SPM005181A SPM005183A SPM005083A SPM005086A SPM005154A SPM005238A SPM005251A SPM005253A SPM005262A SPM005266A SPM005270A SPM005271A SPM005295A SPM005302A SPM005305A SPM005308A SPM005309A SPM005312A SPM005318A SPM005319A SPM005320A SPM005323A SPM005325A SPM005327A SPM005328A SPM005334A SPM005337A SPM005341A SPM005344A SPM005347A SPM005354A SPM005357A SPM005358A SPM005360A SPM005362A SPM005363A SPM005364A SPM005365A SPM005367A SPM005368A SPM005369A SPM005370A SPM005372A SPM005376A SPM005380A SPM005381A SPM005384A SPM005389A SP
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
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… (this page)
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