CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
This recall is currently active, issued June 26, 2024. It was issued by Medtronic Inc..
- Company
- Medtronic Inc.
- Recall Initiated
- April 16, 2024
- Posted
- June 26, 2024
- Recall Number
- Z-2211-2024
- Quantity
- 9 units
- Firm Location
- Mounds View, MN
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
GTIN: 00763000178543, Serial Numbers: RSG601442S, RSG601443S, RSG601445S, RSG601446S, RSG601449S, RSG601461S, RSG601467S, RSG601478S; GTIN: 00763000711382, Serial Number: RSG601428S.
Root Cause
Nonconforming Material/Component
Action Taken
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.