FDA Device recall Z-1711-2023
ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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 resynch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1711-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-10 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; 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.
Identifiers
| code_info | GTIN 00643169837713, Lot Serial Numbers: CWA218162H, CWA219897H, CWA221224H, CWA222730H, CWA223319H, CWA224001H, CWA23…GTIN 00643169837713, Lot Serial Numbers: CWA218162H, CWA219897H, CWA221224H, CWA222730H, CWA223319H, CWA224001H, CWA230660H, CWA212204H, CWA215507H, CWA219655H, CWA228049H, CWA228101H, CWA230635H, CWA230642H, CWA213967H, CWA217145H, CWA220168H, CWA225093H, CWA229346H, CWA232234H, CWA215257H, CWA215420H, CWA221756H, CWA221922H, CWA222159H, CWA225001H, CWA225149H, CWA225777H, CWA227620H, CWA227845H, CWA228935H, CWA229962H, CWA231576H, CWA231578H, CWA213741H, CWA216957H, CWA223516H, CWA225894H, CWA231485H, CWA211463H, CWA211464H, CWA211465H, CWA211466H, CWA211467H, CWA211468H, CWA211470H, CWA214199H, CWA214200H, CWA214201H, CWA214203H, CWA214205H, CWA214208H, CWA214210H, CWA214211H, CWA214212H, CWA214213H, CWA217480H, CWA217481H, CWA217482H, CWA217483H, CWA217484H, CWA217485H, CWA220397H, CWA220400H, CWA220407H, CWA220408H, CWA222904H, CWA224042H, CWA226903H, CWA226919H, CWA230608H, CWA230609H, CWA230611H, CWA230612H, CWA217020H, CWA220851H, CWA224216H, CWA226111H, CWA230832H, CWA231351H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1711-2023%22
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