Recalls / —
—#208080
Product
PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
- FDA product code
- LWS — Implantable Cardioverter Defibrillator (Non-Crt)
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P980016S653
- Affected lot / code info
- 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.
Why it was recalled
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Medtronic Inc.
- Address
- 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391
Distribution
- 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.
Timeline
- Recall initiated
- 2024-04-16
- Posted by FDA
- 2024-06-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #208080. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.