Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
These labels are deterministic app interpretations, not FDA categories.
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Code information
Serial Numbers: RTK602501S, RTK602506S
Distribution pattern
Distribution to US states of GA, PA, NJ, and France
device · product 2 of 3
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
These labels are deterministic app interpretations, not FDA categories.
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Code information
Serial Numbers: RTP601047S, RTP601055S
Distribution pattern
Distribution to US states of GA, PA, NJ, and France
device · product 3 of 3
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
These labels are deterministic app interpretations, not FDA categories.
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Code information
Serial Numbers: RSN600251S, RSN600656S
Distribution pattern
Distribution to US states of GA, PA, NJ, and France
