Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
Check against the official notice below — it lists the full affected range.
Medtronic is recalling Cobalt implantable cardioverter defibrillators with cardiac resynchronization therapy (CRT-D) due to the potential for reduced shock energy during high-voltage therapy. Affected devices may deliver approximately 79% of their programmed energy instead of the full intended amount. The recall involves 1,408 units distributed worldwide, including specific model numbers DTPB2D4 and DTPB with identified serial numbers.
The source document does not specify a remedy or what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Reason for recall: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Distribution: Worldwide Distribution Quantity: 1408 units Lot/code info: a. Model Numbers: DTPB2D4: GTIN 00763000178215, Serial Numbers: RTO600239S, RTO600280S, RTO600409S, RTO600468S, RTO600544S, RTO600701S, RTO600712S, RTO601012S, RTO601031S, RTO601113S, RTO601150S, RTO601156S, RTO601205S, RTO601223S, RTO601549S, RTO601612S, RTO601620S, RTO601784S, RTO601793S, RTO601819S, RTO601823S, RTO601830S, RTO601845S, RTO601846S, RTO601858S, RTO601860S, RTO601862S, RTO601891S, RTO601905S, RTO601945S, RTO601960S, RTO601965S, RTO601986S, RTO602000S, RTO602002S, RTO602029S, RTO602031S, RTO602056S, RTO602107S, RTO602110S, RTO602116S, RTO602159S, RTO602164S, RTO602173S, RTO602183S, RTO602224S, RTO602260S, RTO602261S, RTO602266S, RTO602297S, RTO602303S, RTO602308S, RTO602311S, RTO602324S, RTO602326S, RTO602330S, RTO602331S, RTO602333S, RTO602336S, RTO602340S, RTO602354S, RTO602362S, RTO602372S, RTO602375S, RTO602427S, RTO602431S, RTO602435S, RTO602447S, RTO602452S, RTO602468S, RTO602479S, RTO602487S, RTO602493S, RTO602513S, RTO602516S, RTO602520S, RTO602524S, RTO602536S, RTO602544S, RTO602545S, RTO602556S, RTO602562S, RTO602568S, RTO602577S, RTO602578S, RTO602596S, RTO602598S, RTO602600S; GTIN 00763000178239, Serial Numbers: RTO600028S, RTO600029S, RTO600030S, RTO600031S, RTO600033S, RTO600034S, RTO600036S, RTO600037S, RTO600038S, RTO600040S, RTO600041S, RTO600042S, RTO600043S, RTO600045S, RTO600046S, RTO600047S, RTO600048S, RTO600049S, RTO600050S, RTO600051S, RTO600052S, RTO600053S, RTO600054S, RTO600055S, RTO600056S, RTO600057S, RTO600058S, RTO600060S, RTO6000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.