CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators
Summary
The FDA issued a Class I for CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillato.
Details
Source
Device Recall
External ID
Z-1741-2023
Action Date
2023-06-28
Status
Ongoing
Category
device
Product Description
CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators
Lot/Code Info: 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
Quantity Affected: 207 units
Reason for Recall
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.
Distribution
US Nationwide - Worldwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-10
Company
Mounds View, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 246 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 138 FDA actions in our database, including 138 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) have FDA actions?
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 138 FDA actions in our database, including 138 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1741-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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