FDA Medical Device Recalls (openFDA)
Medtronic Inc.: COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
- Recall number
- Z-2210-2024
- Recalling firm
- Medtronic Inc.
- Product
- COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
- Status
- Open, Classified
- Initiated
- 2024-04-16
- Posted
- 2024-06-26
- Terminated
- not on file
- Reason
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 8 units
- 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, serial or model codes
- GTIN: 00763000711344, Serial Numbers: RSC604641S, RSC604642S, RSC604643S, RSC604644S, RSC604647S, RSC604653S, RSC604654S, RSC604655S.
- 510(k) numbers
- not on file
- PMA numbers
- ["P980016S713"]
- Product code
- LWS
- Firm FEI
- 2182208
- Firm city
- Mounds View
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28