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Open, Classified

COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator

FDA Recall Z-2206-2024 · Posted 2024-06-26

Recalling FirmMedtronic Inc.
Recall StatusOpen, Classified
Product CodeLWS
Date Initiated2024-04-16
Product Quantity9

Reason for Recall

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

Firm Action

On about 04/18/2024, Medtronic notified customers that they were retrieving distributed units that may have undergone a specific manufacturing sequence that requires additional engineering evaluation. They requested that customers acknowledge the letter with signature.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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