FDA recall Z-2199-2024

Product

EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2199-2024