CLASS I ONGOING Device recall · Reported 28 Jun 2023 · FDA Enforcement Report
Crt-d Dtbb2q1 Viva Quad S Is4/df1 Intl recalled
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling Crt-d Dtbb2q1 Viva Quad S Is4/df1 Intl, distributed nationwide in the US. The recall was initiated on 10 May 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1747-2023
- FDA event ID
- 92328
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 10 May 2023
- FDA classified
- 16 Jun 2023
- Reported
- 28 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Pacemakers & Defibrillators
Timeline
| 10 May 2023 | Recall initiated by company | |
| 16 Jun 2023 | Classified by FDA | +37 days |
| 28 Jun 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter Defibrillators
Where it was distributed
US Nationwide - Worldwide Distribution
Questions about this recall
Is Crt-d Dtbb2q1 Viva Quad S Is4/df1 Intl recalled?
Yes. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled Crt-d Dtbb2q1 Viva Quad S Is4/df1 Intl on 10 May 2023. The recall is Class I and its status is Ongoing. Recall number Z-1747-2023.
Why was it recalled?
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.
Which lots are affected?
GTIN 00643169980181, Lot Serial Numbers: BLQ600039S, BLQ600033S, BLQ600034S, BLQ600035S, BLQ600036S, BLQ600037S, BLQ600038S
Where was it sold?
US Nationwide - Worldwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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