Recall archive / FDA device enforcement
CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators — FDA record Z-1744-2023
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 DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; 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
- 193 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1744-2023
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 00643169720145, Lot Serial Numbers: BLK205268H, BLK205272H, BLK205461H, BLK205544H, BLK205582H, BLK205328H, BLK205358H, BLK205475H, BLK205492H, BLK205304H, BLK205346H, BLK205364H, BLK205269H, BLK205352H, BLK205349H, BLK205400H, BLK205432H, BLK205451H, BLK205309H, BLK205310H, BLK205315H, BLK205514H, BLK205424H, BLK205466H, BLK205513H, BLK205279H, BLK205504H, BLK205314H, BLK205376H, BLK205377H, BLK205394H, BLK205443H, BLK205444H, BLK205275H, BLK205284H, BLK205285H, BLK205287H, BLK205298H, BLK205312H, BLK205379H, BLK205389H, BLK205406H, BLK205415H, BLK205419H, BLK205429H, BLK205431H, BLK205435H, BLK205464H, BLK205471H, BLK205478H, BLK205512H, BLK205517H, BLK205524H, BLK205528H, BLK205541H, BLK205427H, BLK205289H, BLK205387H, BLK205566H, BLK205374H, BLK205508H, BLK205369H, BLK205395H, BLK205311H, BLK205405H, BLK205445H, BLK205472H, BLK205522H, BLK205523H, BLK205531H, BLK205537H, BLK205554H, BLK205450H, BLK205583H, BLK205166H, BLK205286H, BLK205296H, BLK205307H, BLK205329H, BLK205371H, BLK205372H, BLK205458H, BLK205494H, BLK205498H, BLK205570H, BLK205341H, BLK205305H, BLK205317H, BLK205354H, BLK205468H, BLK205469H, BLK205574H, BLK205345H, BLK205363H, BLK205378H, BLK205539H, BLK205534H, BLK205535H, BLK205536H, BLK205295H, BLK205308H, BLK205323H, BLK205335H, BLK205428H, BLK205434H, BLK205440H, BLK205448H, BLK205449H, BLK205489H, BLK205457H, BLK205306H, BLK205276H, BLK205403H, BLK205326H, BLK205330H, BLK205299H, BLK205483H, BLK205565H, BLK205459H, BLK205259H, BLK205292H, BLK205516H, BLK205408H, BLK205418H, BLK205476H, BLK205409H, BLK205548H, BLK205525H, BLK205511H, BLK205293H, BLK205370H, BLK205380H, BLK205433H, BLK205506H, BLK205288H, BLK205327H, BLK205396H, BLK205465H, BLK205588H, BLK205302H, BLK205367H, BLK205375H, BLK205399H, BLK205454H, BLK205470H, BLK205291H, BLK205482H, BLK205351H, BLK205324H, BLK205520H, BLK205273H, BLK205496H, BLK205366H, BLK205262H, BLK205313H, BLK205331H, BLK205493H, BLK205368H, BLK205301H, BLK205386H, BLK205390H, BLK205401H, BLK205402H, BLK205417H, BLK205258H, BLK205260H, BLK205267H, BLK205320H, BLK205357H, BLK205410H, BLK205412H, BLK205515H, BLK205584H, BLK205263H, BLK205348H, BLK205334H, BLK205337H, BLK205338H, BLK205373H, BLK205384H, BLK205481H, BLK205491H, BLK205526H, BLK205527H, BLK205530H, BLK205532H, BLK205575H, BLK205577H, BLK205578H, BLK205447H, BLK205509H, BLK205414H, BLK205501H |
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.