FDAFDA · Food and drugs·Recall number Z-2505-2020
CareLink SmartSync Device Manager, Model Number 24970A
Published July 15, 2020 · Recall initiated: June 4, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distributor
- worldwide
- Lot
- serial numbers: SPM001078A SPM001117A SPM001120A SPM001139A SPM001140A SPM001141A SPM001174A SPM001231A SPM001250A SPM001251A SPM001252A SPM001253A SPM001262A SPM001265A SPM001266A SPM001270A SPM001281A SPM001284A SPM001285A SPM001363A SPM001377A SPM001394A SPM001396A SPM001398A SPM001403A SPM001404A SPM001407A SPM001419A SPM001424A SPM001425A SPM001441A SPM001445A SPM001449A SPM001456A SPM001463A SPM001465A SPM001474A SPM001477A SPM001478A SPM001482A SPM001484A SPM001486A SPM001491A SPM001519A SPM001544A SPM001545A SPM001552A SPM001554A SPM001555A SPM001556A SPM001557A SPM001559A SPM001560A SPM001561A SPM001562A SPM001571A SPM001581A SPM001584A SPM001587A SPM001588A SPM001633A SPM001659A SPM001660A SPM001661A SPM001662A SPM001663A SPM001664A SPM001665A SPM001666A SPM001667A SPM001668A SPM001669A SPM001670A SPM001671A SPM001672A SPM001673A SPM001674A SPM001675A SPM001676A SPM001677A SPM001683A SPM001684A SPM001685A SPM001686A SPM001704A SPM001705A SPM001706A SPM001707A SPM001709A SPM001710A SPM001711A SPM001712A SPM001713A SPM001714A SPM001715A SPM001716A SPM001719A SPM001720A SPM001721A SPM001723A SPM001732A SPM001733A SPM001734A SPM001735A SPM001738A SPM001739A SPM001745A SPM001746A SPM001747A SPM001748A SPM001749A SPM001751A SPM001753A SPM001754A SPM001756A SPM001759A SPM001760A SPM001766A SPM001771A SPM001774A SPM001775A SPM001776A SPM001779A SPM001781A SPM001782A SPM001784A SPM001786A SPM001787A SPM001793A SPM001795A SPM001796A SPM001798A SPM001799A SPM001800A SPM001802A SPM001803A SPM001805A SPM001806A SPM001807A SPM001808A SPM001809A SPM001812A SPM001813A SPM001816A SPM001817A SPM001818A SPM001842A SPM001846A SPM001875A SPM001878A SPM001880A SPM001883A SPM001884A SPM001885A SPM001889A SPM001896A SPM001901A SPM001929A SPM001935A SPM001936A SPM001961A SPM001967A SPM001971A SPM001973A SPM001974A SPM001975A SPM001976A SPM001977A SPM001982A SPM001983A SPM001984A SPM001985A SPM001986A SPM001988A SPM001989A SPM002001A SPM002005A SPM002024A SPM002035A SPM002041A SPM002068A SPM002072A SPM002085A SPM002107A SPM002108A SPM002109A SPM002110A SPM002113A SPM002114A SPM002115A SPM002117A SPM002121A SPM002122A SPM002125A SPM002129A SPM002130A SPM002131A SPM002132A SPM002134A SPM002145A SPM002150A SPM002179A SPM002198A SPM002205A SPM002213A SPM002217A SPM002219A SPM002232A SPM002268A SPM002269A SPM002292A SPM002294A SPM002295A SPM002310A SPM002312A SPM002315A SPM002316A SPM002335A SPM002342A SPM002343A SPM002344A SPM002347A SPM002365A SPM002367A SPM002373A SPM002374A SPM002375A SPM002386A SPM002416A SPM002424A SPM002451A SPM002456A SPM002458A SPM002459A SPM002460A SPM002461A SPM002462A SPM002463A SPM002464A SPM002465A SPM002538A SPM002540A SPM002542A SPM002546A SPM002547A SPM002553A SPM002554A SPM002555A SPM002557A SPM002558A SPM002559A SPM002560A SPM002561A SPM002562A SPM002563A SPM002565A SPM002568A SPM002569A SPM002572A SPM002595A SPM002597A SPM002599A SPM002600A SPM002601A SPM002602A SPM002603A SPM002604A SPM002606A SPM002608A SPM002609A SPM002610A SPM002611A SPM002612A SPM002613A SPM002614A SPM002615A SPM002616A SPM002617A SPM002618A SPM002656A SPM002657A SPM002658A SPM002659A SPM002660A SPM002661A SPM002662A SPM002663A SPM002664A SPM002665A SPM002698A SPM002699A SPM002703A SPM002704A SPM002705A SPM002706A SPM002708A SPM002709A SPM002710A SPM002711A SPM002712A SPM002714A SPM002736A SPM002756A SPM002885A SPM002997A SPM003000A SPM003001A SPM003035A SPM003036A SPM003037A SPM003038A SPM003042A SPM003043A SPM003046A SPM003047A SPM003048A SPM003051A SPM003053A SPM003054A SPM003058A SPM003059A SPM003060A SPM003061A SPM003063A SPM003064A SPM003065A SPM003066A SPM003067A SPM003068A SPM003069A SPM003070A SPM003071A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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