Recall archive / FDA device enforcement

ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators — FDA record Z-1714-2023

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: 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.
Classification: Class I
Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity: 35,961 units
Agency-reported status: Ongoing
Source record identifier: Z-1714-2023

Open the official record

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
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PGZ632707S, PGZ632719S, PGZ632971S, PGZ633091S, PGZ633542S, PGZ636307S, PGZ6...

Label field

Details supplied by the agency

Lot, code or applicability

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, 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PGZ642995S, PGZ643024S, PGZ643029S, PGZ643031S, PGZ643116S, PGZ643125S, PGZ643132S, PGZ632550S, PGZ642651S, PGZ642699S, PGZ643011S, PGZ631206S, PGZ632998S, PGZ639988S, PGZ642808S, PGZ622760S, PGZ624428S, PGZ624454S, PGZ626307S, PGZ626308S, PGZ626320S, PGZ629359S, PGZ629360S, PGZ630806S, PGZ633607S, PGZ633642S, PGZ635268S, PGZ635275S, PGZ635279S, PGZ635283S, PGZ635285S, PGZ635288S, PGZ638254S, PGZ638642S, PGZ642859S, PGZ643058S, PGZ622804S, PGZ623857S, PGZ633078S, PGZ636241S, PGZ636291S, PGZ638439S, PGZ641159S, PGZ642707S, PGZ643220S, PGZ623567S, PGZ643199S, PGZ629460S, PGZ621728S, PGZ622321S, PGZ624416S, PGZ624417S, PGZ624418S, PGZ624419S, PGZ624459S, PGZ626330S, PGZ626581S, PGZ626809S, PGZ628633S, PGZ628638S, PGZ628963S, PGZ629012S, PGZ629283S, PGZ629394S, PGZ629407S, PGZ629996S, PGZ630092S, PGZ630112S, PGZ631040S, PGZ631097S, PGZ631156S, PGZ631220S, PGZ632298S, PGZ632563S, PGZ632867S, PGZ632931S, PGZ633069S, PGZ633596S, PGZ634295S, PGZ636297S, PGZ637842S, PGZ637843S, PGZ637846S, PGZ638460S, PGZ639150S, PGZ639295S, PGZ639672S, PGZ641146S, PGZ641520S, PGZ641522S, PGZ641524S, PGZ641536S, PGZ643109S, PGZ630395S, PGZ638084S, PGZ640839S, PGZ624056S, PGZ624426S, PGZ635265S, PGZ629998S, PGZ638859S, PGZ638883S, PGZ641084S, PGZ641110S, PGZ643138S, PGZ623070S, PGZ624080S, PGZ624464S, PGZ629529S, PGZ632811S, PGZ641592S, PGZ641684S, PGZ642778S, PGZ623904S, PGZ631888S, PGZ633000S, PGZ633667S, PGZ638379S, PGZ643151S, PGZ632031S, PGZ632042S, PGZ627397S, PGZ627398S, PGZ638134S, PGZ638184S, PGZ641086S, PGZ641504S, PGZ643213S, PGZ624348S, PGZ622305S, PGZ627184S, PGZ628636S, PGZ629051S, PGZ629130S, PGZ630991S, PGZ631059S, PGZ632768S, PGZ633116S, PGZ633665S, PGZ633675S, PGZ633803S, PGZ641125S, PGZ642675S, PGZ643177S, PGZ644090S, PGZ640099S, PGZ631098S, PGZ632223S, PGZ632635S, PGZ635679S, PGZ636278S, PGZ638024S, PGZ643219S, PGZ643809S, PGZ637816S, PGZ638094S, PGZ642693S, PGZ632275S, PGZ636419S, PGZ638302S, PGZ638720S, PGZ640873S, PGZ643260S, PGZ623983S, PGZ631253S, PGZ633148S, 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PGZ633091S, PGZ633542S, PGZ636307S, PGZ6...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

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.

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.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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