Device recall: ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators

Class I FDA enforcement event 92328. Recall start date: 10 May 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) started this device recall on 10 May 2023. The firm address in the FDA record is in Mounds View, MN. FDA put the recall in Class I. FDA event 92328 has 120 product records. The first FDA enforcement report date is 28 Jun 2023. The record gives the status Ongoing.

FDA enforcement report The 120 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide - Worldwide Distribution

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

120 product records in the event.

FDA event 92328: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1704-2023	ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators	2179 units	Class I	Ongoing	28 Jun 2023
Z-1705-2023	ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators	522 units	Class I	Ongoing	28 Jun 2023
Z-1706-2023	ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators	1 unit	Class I	Ongoing	28 Jun 2023
Z-1707-2023	ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators	2282 units	Class I	Ongoing	28 Jun 2023
Z-1708-2023	ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators	727 units	Class I	Ongoing	28 Jun 2023
Z-1709-2023	ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators	5176 units	Class I	Ongoing	28 Jun 2023
Z-1710-2023	ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators	4056 units	Class I	Ongoing	28 Jun 2023
Z-1711-2023	ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators	22484 units	Class I	Ongoing	28 Jun 2023
Z-1712-2023	ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators	61,404 units	Class I	Ongoing	28 Jun 2023
Z-1713-2023	ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators	8626 units	Class I	Ongoing	28 Jun 2023
Z-1714-2023	ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators	35,961 units	Class I	Ongoing	28 Jun 2023
Z-1715-2023	ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators	10,903 units	Class I	Ongoing	28 Jun 2023
Z-1716-2023	ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators	37,547 units	Class I	Ongoing	28 Jun 2023
Z-1717-2023	ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators	3801 units	Class I	Ongoing	28 Jun 2023
Z-1718-2023	ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators	11,239 units	Class I	Ongoing	28 Jun 2023
Z-1719-2023	ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators	2831 units	Class I	Ongoing	28 Jun 2023
Z-1720-2023	ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators	8219 units	Class I	Ongoing	28 Jun 2023
Z-1721-2023	ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators	2748 units	Class I	Ongoing	28 Jun 2023
Z-1722-2023	ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators	3 units	Class I	Ongoing	28 Jun 2023
Z-1723-2023	ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators	22,114 units	Class I	Ongoing	28 Jun 2023
Z-1724-2023	ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators	6 units	Class I	Ongoing	28 Jun 2023
Z-1725-2023	ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators	1941 units	Class I	Ongoing	28 Jun 2023
Z-1726-2023	ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators	11,645 units	Class I	Ongoing	28 Jun 2023
Z-1727-2023	ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators	487 units	Class I	Ongoing	28 Jun 2023
Z-1728-2023	ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators	2018 Units	Class I	Ongoing	28 Jun 2023
Z-1729-2023	CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators	1473 units	Class I	Ongoing	28 Jun 2023
Z-1730-2023	CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter Defibrillators	1 unit	Class I	Ongoing	28 Jun 2023
Z-1731-2023	CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators	661 units	Class I	Ongoing	28 Jun 2023
Z-1732-2023	CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators	373 units	Class I	Ongoing	28 Jun 2023
Z-1733-2023	CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators	891 units	Class I	Ongoing	28 Jun 2023
Z-1734-2023	CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators	14 units	Class I	Ongoing	28 Jun 2023
Z-1735-2023	CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators	4354 units	Class I	Ongoing	28 Jun 2023
Z-1736-2023	CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators	8 units	Class I	Ongoing	28 Jun 2023
Z-1737-2023	CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators	2904 units	Class I	Ongoing	28 Jun 2023
Z-1738-2023	CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators	1132 units	Class I	Ongoing	28 Jun 2023
Z-1739-2023	CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators	2931 units	Class I	Ongoing	28 Jun 2023
Z-1740-2023	CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators	1 unit	Class I	Ongoing	28 Jun 2023
Z-1741-2023	CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators	207 units	Class I	Ongoing	28 Jun 2023
Z-1742-2023	CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators	182 units	Class I	Ongoing	28 Jun 2023
Z-1743-2023	CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators		Class I	Ongoing	28 Jun 2023
Z-1744-2023	CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators	193 units	Class I	Ongoing	28 Jun 2023
Z-1745-2023	CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators	1076 units	Class I	Ongoing	28 Jun 2023
Z-1746-2023	CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators	435 units	Class I	Ongoing	28 Jun 2023
Z-1747-2023	CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter Defibrillators	7 units	Class I	Ongoing	28 Jun 2023
Z-1748-2023	CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators	523 units	Class I	Ongoing	28 Jun 2023
Z-1749-2023	CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators	7921 units	Class I	Ongoing	28 Jun 2023
Z-1750-2023	CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators	3355 units	Class I	Ongoing	28 Jun 2023
Z-1751-2023	CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators	1754 units	Class I	Ongoing	28 Jun 2023
Z-1752-2023	CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators	7994 units	Class I	Ongoing	28 Jun 2023
Z-1753-2023	CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators	11794 units	Class I	Ongoing	28 Jun 2023
Z-1754-2023	CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators	12291 units	Class I	Ongoing	28 Jun 2023
Z-1755-2023	CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators	8602 units	Class I	Ongoing	28 Jun 2023
Z-1756-2023	CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators	58706 units	Class I	Ongoing	28 Jun 2023
Z-1757-2023	CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators	3570 units	Class I	Ongoing	28 Jun 2023
Z-1758-2023	CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators	4593 units	Class I	Ongoing	28 Jun 2023
Z-1759-2023	CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators	1658 units	Class I	Ongoing	28 Jun 2023
Z-1760-2023	CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators	23223 units	Class I	Ongoing	28 Jun 2023
Z-1761-2023	CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators	3005 units	Class I	Ongoing	28 Jun 2023
Z-1762-2023	CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators	2767 units	Class I	Ongoing	28 Jun 2023
Z-1763-2023	CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators	2173 units	Class I	Ongoing	28 Jun 2023

The table shows 60 of 120 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2023: 917
Share of these events in Class I: 10%
Product records in this event: 120Median of the firm: 2
Events of the firm on the register: 30

Other events of the firm

Other FDA enforcement events of Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Initiated	Product (first record)	Type	Class	Records
22 Jun 2022	Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR IC	Device	Class I	6
20 Apr 2022	The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure,	Device	Class II	1
12 Apr 2022	Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA	Device	Class II	2
18 Jan 2022	LINQ II Insertable Cardiac Monitor	Device	Class II	1
19 Nov 2021	Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.	Device	Class II	1
8 Nov 2021	Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72	Device	Class II	2
12 Oct 2021	Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Cr	Device	Class II	1
9 Sep 2021	C315-HIS Delivery Catheter	Device	Class II	1
1 Jun 2021	Medtronic Reveal LINQ LNQ11 / PA96000	Device	Class II	1
14 May 2021	Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only	Device	Class II	1

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): all 30 events

Official channels

FDA enforcement report Z-1704-2023The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 92328. https://recallregister.com/fda/i/92328/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide - Worldwide Distribution
What quantity of product is in FDA event 92328?: The event has 120 product records. The first record gives this quantity: 2179 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 10% of the 917 device events that started in 2023 are in Class I.