Moderate riskFDA DeviceNov 6, 2026Class II

Medtronic RF Head 24967 recalled for possible Bluetooth disconnections

Medtronic's RF Head 24967 patient connector, which communicates with Medtronic cardiac devices, may have Bluetooth disconnections between the device manager software and its accessories. Disconnections during a SmartSync patient session may lead to harm from undesirable or incomplete parameter programming. No injuries have been reported.

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

What to do

Contact Medtronic about the affected connector; the notice doesn't say what remedy is available.
Check the UDI-DI and serial number of each connector against the lists in the notice (serials begin with RFA).
Contact your patient care team about how to handle SmartSync patient sessions while this is unresolved.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: RF HEAD 24967 PATIENT CONNECTOR and RF HEAD 24967 EUR MKT, communicates with Medtronic cardiac devices, Product Number 24967
Sold in: Nationwide
Made for: All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected: 11741 untis
Illnesses reported: None reported
Manufactured in: 8200 Coral Sea St Ne, Mounds View, Minnesota, United States
Classification: Class II
Recall number: Z-0363-2027

In the FDA's words

Description: RF HEAD 24967 PATIENT CONNECTOR and RF HEAD 24967 EUR MKT, communicates with Medtronic cardiac devices, Product Number 24967 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: 00763000060435, 00763000060428, 00763000060442, 00763000060459, 00763000288242, 00763000257583, 00763000257613, 00763000317799, 00763000257576, 00763000317775, 00763000208394, 00763000424374, 00763000688479, 00763000688509, 00763000688516, 00763000688530, 00763000688554, 00763000688493, 00763000688547, 00763000688486; Serial Numbers: RFA001598A RFA001602A RFA001786A RFA001826A RFA002016A RFA002095A RFA002591A RFA003113A RFA003146A RFA003306A RFA005031A RFA005097A RFA005103A RFA008830A RFA014171A RFA014218A RFA014252A RFA014258A RFA014278A RFA014286A RFA014342A RFA014609A RFA014653A RFA014885A RFA014952A RFA014996A RFA015015A RFA016648A RFA016815A RFA016817A RFA017064A RFA017468A RFA017880A RFA017906A RFA017907A RFA017929A RFA017947A RFA018801A RFA019059A RFA021437A RFA021450A RFA021477A RFA021618A RFA021626A RFA021652A RFA021661A RFA036107A RFA036123A RFA036190A RFA036411A RFA036460A RFA037606A RFA037647A RFA037648A RFA037650A RFA037794A RFA038977A RFA039112A RFA039113A RFA040362A RFA040386A RFA040584A RFA040632A RFA040655A RFA040688A RFA040689A RFA040765A RFA040802A RFA040823A RFA040848A RFA040850A RFA040853A RFA040905A RFA040911A RFA040918A RFA041045A RFA041053A RFA041211A RFA041213A RFA041375A RFA041376A RFA041383A RFA041384A RFA041450A RFA041455A RFA041457A RFA041483A RFA041511A RFA041514A RFA041515A RFA041518A RFA041537A RFA041559A RFA041568A RFA041572A RFA041573A RFA041600A RFA042036A RFA042051A RFA042055A RFA042056A RFA042124A RFA042131A RFA042132A RFA042141A RFA042147A RFA042269A RFA042413A RFA042417A RFA042425A RFA042431A RFA042477A RFA042513A RFA042630A RFA042684A RFA042929A RFA042966A RFA043004A RFA043005A RFA043006A RFA043013A RFA043046A RFA043113A RFA043442A RFA043519A RFA043612A RFA043770A RFA043777A RFA043838A RFA044072A RFA044122A RFA044312A RFA044417A RFA044485A RFA044486A RFA044505A RFA044506A RFA044628A RFA044684A RFA044685A RFA044687A RFA044700A RFA044805A RFA045057A RFA045058A RFA045059A RFA045060A RFA045181A RFA045281A RFA045291A RFA045295A RFA045328A RFA045386A RFA001761A RFA001793A RFA001814A RFA001845A RFA001854A RFA001855A RFA001857A RFA001859A RFA001867A RFA001885A RFA001888A RFA001891A RFA001952A RFA001994A RFA001996A RFA002014A RFA002067A RFA002129A RFA002131A RFA002141A RFA002145A RFA002162A RFA002166A RFA002217A RFA002220A RFA002250A RFA002289A RFA002291A RFA002312A RFA002319A RFA002322A RFA002325A RFA002334A RFA002337A RFA002340A RFA002343A RFA002347A RFA002368A RFA002388A RFA002390A RFA002405A RFA002406A RFA002412A RFA002428A RFA002433A RFA002440A RFA002448A RFA002449A RFA002452A RFA002460A RFA002486A RFA002491A RFA002496A RFA002506A RFA002513A RFA002525A RFA002546A RFA002548A RFA002561A RFA002565A RFA002576A RFA002587A RFA002589A RFA002594A RFA002608A RFA002610A RFA002613A RFA002618A RFA002619A RFA002629A RFA002643A RFA002645A RFA002652A RFA002674A RFA002690A RFA002691A RFA002700A RFA002990A RFA002994A RFA002996A RFA003007A RFA003244A RFA003247A RFA003250A RFA003259A RFA003260A RFA003938A RFA004003A RFA004057A RFA004058A RFA004076A RFA004157A RFA004158A RFA004162A RFA004173A RFA004181A RFA004204A RFA004207A RFA004214A RFA004215A RFA004263A RFA004275A RFA004278A RFA004279A RFA004290A RFA004291A RFA004295A RFA004296A RFA004297A RFA004301A RFA004312A RFA004319A RFA004323A RFA004331A RFA004352A RFA004355A RFA004358A RFA004362A RFA004369A RFA004375A RFA004380A RFA004386A RFA004388A RFA004397A RFA004399A RFA004427A RFA004440A RFA004451A RFA004452A RFA004456A RFA004457A RFA004465A RFA004471A RFA004472A RFA004478A RFA004483A RFA004485A RFA004486A RFA004502A RFA004531A RFA004535A RFA004549A RFA004551A RFA004565A RFA004566A RFA004569A RFA004573A RFA004579A RFA004605A RFA004607A RFA004609A RFA004612A RFA004618A RFA004623A RFA004624A RFA004625A RFA004626A RFA004636A RFA004637A RFA004641A RFA004649A RFA004652A RFA004662A RFA004664A RFA004666A RFA004668A RFA004686A RFA004690A RFA004696A RFA004698A RFA004703A RFA004704A RFA004705A RFA004730A RFA004741A RFA004767A RFA004777A RFA004782A RFA004789A RFA004790A RFA004791A RFA004828A RFA004829A RFA004830A RFA004850A RFA004885A RFA004887A RFA004888A RFA004891A RFA004899A RFA004900A RFA004904A RFA004910A RFA004918A RFA004920A RFA004928A RFA004929A RFA004931A RFA004932A RFA004934A RFA004935A RFA004938A RFA004946A RFA004954A RFA004966A RFA005120A RFA005123A RFA005127A RFA005128A RFA005135A RFA005137A RFA005139A RFA005153A RFA005158A RFA005165A RFA005171A RFA005175A RFA005176A RFA005187A RFA005193A RFA005196A RFA005200A RFA005253A RFA005258A RFA005268A RFA005269A RFA005285A RFA005291A RFA005297A RFA005303A RFA005312A RFA005314A RFA005323A RFA005344A RFA005456A RFA005461A RFA005462A RFA
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…
Z-0362-2027 · 11301 units
RF HEAD 24967 PATIENT CONNECTOR and RF HEAD 24967 EUR MKT, communicates with Medtronic cardiac devices, Product Number 24967 (this page)
Z-0363-2027 · 11741 untis