Device recall: COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Class II FDA enforcement event 94674. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Medtronic Inc. started this device recall on 16 Apr 2024. The firm address in the FDA record is in Mounds View, MN. FDA put the recall in Class II. FDA event 94674 has 23 product records. The first FDA enforcement report date is 3 Jul 2024. The record gives the status Ongoing.
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 . openFDA export of .
Distribution
In the words of FDA.
Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech…
Recalling firm
Medtronic Inc., 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
23 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2190-2024 | COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator | 14 | Class II | Ongoing | 3 Jul 2024 |
| Z-2191-2024 | COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator | 8 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2192-2024 | Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator | 14 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2193-2024 | COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator | 11 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2194-2024 | COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator | 58 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2195-2024 | CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator | 26 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2196-2024 | EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator | 1 unit | Class II | Ongoing | 3 Jul 2024 |
| Z-2197-2024 | EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator | 14 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2198-2024 | EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator | 5 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2199-2024 | EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator | 40 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2200-2024 | PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator | 2 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2201-2024 | MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator | 3 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2202-2024 | MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator | 26 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2203-2024 | PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator | 46 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2204-2024 | MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator | 6 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2205-2024 | MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator | 13 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2206-2024 | COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator | 9 | Class II | Ongoing | 3 Jul 2024 |
| Z-2207-2024 | COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator | 36 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2208-2024 | COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator | 4 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2209-2024 | Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator | 5 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2210-2024 | COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator | 8 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2211-2024 | CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator | 9 units | Class II | Ongoing | 3 Jul 2024 |
| Z-2212-2024 | Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model… | 82 units | Class II | Ongoing | 3 Jul 2024 |
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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 23Median of the firm: 1
- Events of the firm on the register
- 47
Other events of the firm
Official channels
- FDA enforcement report Z-2190-2024The 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.
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Cite this page
Recall Register. FDA enforcement event 94674. https://recallregister.com/fda/ii/94674/. Source: openFDA enforcement reports. Data through .
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:
Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech…
- What quantity of product is in FDA event 94674?
- The event has 23 product records. The first record gives this quantity:
14
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.