Recall archive / FDA device enforcement
CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators — FDA record Z-1741-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators
- Reason
- There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- Classification
- Class I
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 207 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1741-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 00643169720329, Lot Serial Numbers: BLO214422H, BLO214561H, BLO214374H, BLO214534H, BLO214440H, BLO214546H, BLO214564H, BLO214574H, BLO214347H, BLO214424H, BLO214577H, BLO214311H, BLO214464H, BLO214492H, BLO214410H, BLO214276H, BLO214283H, BLO214290H, BLO214368H, BLO214376H, BLO214395H, BLO214448H, BLO214539H, BLO214405H, BLO214499H, BLO214390H, BLO214496H, BLO214548H, BLO214344H, BLO214362H, BLO214352H, BLO214253H, BLO214274H, BLO214288H, BLO214342H, BLO214444H, BLO214327H, BLO214333H, BLO214431H, BLO214473H, BLO214273H, BLO214317H, BLO214418H, BLO214445H, BLO213867H, BLO214272H, BLO214289H, BLO214316H, BLO214526H, BLO214261H, BLO214279H, BLO214287H, BLO214296H, BLO214297H, BLO214301H, BLO214302H, BLO214303H, BLO214436H, BLO214535H, BLO214536H, BLO214543H, BLO214549H, BLO214550H, BLO214551H, BLO214552H, BLO214553H, BLO214571H, BLO214579H, BLO214581H, BLO214582H, BLO214584H, BLO214585H, BLO214586H, BLO214335H, BLO214308H, BLO214379H, BLO214348H, BLO214366H, BLO214312H, BLO214353H, BLO214530H, BLO214568H, BLO214260H, BLO214334H, BLO214413H, BLO214430H, BLO214437H, BLO214441H, BLO214475H, BLO214570H, BLO214397H, BLO214321H, BLO214394H, BLO214538H, BLO214269H, BLO214271H, BLO214282H, BLO214315H, BLO214343H, BLO214365H, BLO214383H, BLO214391H, BLO214417H, BLO214423H, BLO214446H, BLO214463H, BLO214501H, BLO214513H, BLO214532H, BLO214547H, BLO214559H, BLO214563H, BLO214565H, BLO213863H, BLO214567H, BLO214291H, BLO214295H, BLO214322H, BLO214351H, BLO214358H, BLO214369H, BLO214404H, BLO214407H, BLO214280H, BLO214416H, BLO214517H, BLO214533H, BLO214558H, BLO214452H, BLO214527H, BLO214377H, BLO214491H, BLO214460H, BLO214502H, BLO214469H, BLO214471H, BLO214506H, BLO214427H, BLO214320H, BLO214434H, BLO214453H, BLO214467H, BLO214512H, BLO214313H, BLO214447H, BLO214449H, BLO214485H, BLO214318H, BLO214415H, BLO214324H, BLO214477H, BLO214454H, BLO214281H, BLO214569H, BLO214385H, BLO214509H, BLO214419H, BLO214420H, BLO214443H, BLO214363H, BLO214520H, BLO214306H, BLO214298H, BLO214340H, BLO214503H, BLO214504H, BLO214505H, BLO214378H, BLO214451H, BLO214332H, BLO214486H, BLO214382H, BLO214286H, BLO214364H, BLO214381H, BLO214386H, BLO214406H, BLO214459H, BLO214326H, BLO213864H, BLO214408H, BLO214426H, BLO214488H, BLO214293H, BLO214264H, BLO214305H, BLO214337H, BLO214388H, BLO214432H, BLO214489H, BLO214357H, BLO214389H, BLO214392H, BLO214411H, BLO214455H, BLO214461H, BLO214494H, BLO214284H, BLO214474H, BLO214507H, BLO214555H, BLO214560H, BLO214572H, BLO214573H, BLO214576H, BLO214373H, BLO214508H |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide - Worldwide Distribution
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 28, 2023
- Recall initiation date
- May 10, 2023
- Center classification date
- Jun 16, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.