EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator

Is this the product you have?

• EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator

Lot codes and dates

• GTIN00763000206192
• Serial Number
  • CWC613698S
  • CWC613700S
  • CWC613713S
  • CWC613715S
  • CWC613717S

Amount recalled

5 units

This recall covers 23 products

The agency filed one notice per product. You are reading one of them; the other 22 are below.

• COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter…
• COBALT XT HF CRT-D MRI SureScan
• Cobalt XT HF CDT-D MRI SureScan
• COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter…
• COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter…
• CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter…
• EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
• EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
• EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
• PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
• MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
• MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator

10 more are in the archive.

Where it was sold

• Nationwide
• GA
• CA
• CT
• FL
• IN
• MA
• MI
• NC
• NH
• NJ
• NM
• NY
• OH
• TX
• VA

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.