Medtronic Inc. PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
Brand
Medtronic Inc.
Lot Codes / Batch Numbers
GTIN: 00763000611965, Serial Numbers: CWL619625S, CWL619626S, CWL619627S, CWL619631S, CWL619632S, CWL619633S, CWL619634S, CWL619635S, CWL619636S, CWL619637S, CWL619638S, CWL619639S, CWL619640S, CWL619641S, CWL619642S, CWL619645S, CWL619648S, CWL619649S, CWL619650S, CWL619652S, CWL619678S, CWL619683S, CWL619700S, CWL619733S, CWL619735S, CWL620413S, CWL620414S, CWL620415S, CWL620416S, CWL620417S, CWL620421S, CWL620422S, CWL620423S, CWL620424S, CWL620425S, CWL620426S, CWL620432S, CWL620477S, CWL620480S, CWL620483S, CWL620496S, CWL620500S, CWL620501S, CWL620502S, CWL620633S, CWL620652S.
Products Sold
GTIN: 00763000611965, Serial Numbers: CWL619625S, CWL619626S, CWL619627S, CWL619631S, CWL619632S, CWL619633S, CWL619634S, CWL619635S, CWL619636S, CWL619637S, CWL619638S, CWL619639S, CWL619640S, CWL619641S, CWL619642S, CWL619645S, CWL619648S, CWL619649S, CWL619650S, CWL619652S, CWL619678S, CWL619683S, CWL619700S, CWL619733S, CWL619735S, CWL620413S, CWL620414S, CWL620415S, CWL620416S, CWL620417S, CWL620421S, CWL620422S, CWL620423S, CWL620424S, CWL620425S, CWL620426S, CWL620432S, CWL620477S, CWL620480S, CWL620483S, CWL620496S, CWL620500S, CWL620501S, CWL620502S, CWL620633S, CWL620652S.
Medtronic Inc. is recalling PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator due to Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026