# FDA recall Z-2212-2024

> **Medtronic Inc.** · Class II · device recall initiated 2024-04-16.

## Product

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 Number DTMB2D4.     f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1.      g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ.     h. COMPIA MRI QUAD CRT-D SureScan, Model Number DTMC2QQ.     i. EVERA MRI XT DR SureScan, Model Number DDMB2D4.     j. VISIA AF MRI XT VR SureScan, Model Number DVFB2D1.     k. VISIA AF MRI S VR SureScan, Model Number DVFC3D4.      l. VISIA AF MRI XT VR SureScan, Model Number DVFB2D4.

## Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

## 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 Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-2212-2024
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-16
- **Report date:** 2024-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mounds View, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2212-2024

## Citation

> AI Analytics. FDA recall Z-2212-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2212-2024. Source: US FDA. Licensed CC0.

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