FDA Device recall Z-1714-2023
ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4 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-1714-2023 |
| 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 DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; 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 00643169443419, Lot Serial Numbers: PGZ624363S, PGZ631078S, PGZ638449S, PGZ638465S, PGZ623851S, PGZ645877S, PGZ62…GTIN 00643169443419, Lot Serial Numbers: PGZ624363S, PGZ631078S, PGZ638449S, PGZ638465S, PGZ623851S, PGZ645877S, PGZ621671S, PGZ621673S, PGZ623094S, PGZ623561S, PGZ623984S, PGZ623985S, PGZ623986S, PGZ623991S, PGZ624447S, PGZ626933S, PGZ626995S, PGZ627005S, PGZ627071S, PGZ629198S, PGZ629204S, PGZ629217S, PGZ631034S, PGZ631035S, PGZ631036S, PGZ631037S, PGZ633073S, PGZ633357S, PGZ633680S, PGZ635203S, PGZ635731S, PGZ635749S, PGZ635812S, PGZ635815S, PGZ635820S, PGZ637440S, PGZ637885S, PGZ637919S, PGZ637947S, PGZ637950S, PGZ638090S, PGZ638096S, PGZ638463S, PGZ641070S, PGZ641071S, PGZ641072S, PGZ641083S, PGZ641140S, PGZ641168S, PGZ641651S, PGZ641687S, PGZ642430S, PGZ643962S, PGZ645328S, PGZ622752S, PGZ626967S, PGZ629552S, PGZ630964S, PGZ631210S, PGZ632646S, PGZ637386S, PGZ641102S, PGZ643196S, PGZ644010S, PGZ629356S, PGZ632534S, PGZ636328S, PGZ636330S, PGZ637349S, PGZ638180S, PGZ638396S, PGZ641545S, PGZ641547S, PGZ623932S, PGZ624470S, PGZ629461S, PGZ630997S, PGZ631127S, PGZ636208S, PGZ638240S |
|---|
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-1714-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.