Cobalt XT DR MRI SureScan recallZ-2209-2024 · Medtronic Inc. · initiated Apr 16, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2209-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 16, 2024
- Posted by the FDA
- Jun 26, 2024
- Recalling firm
- Medtronic Inc.
- Quantity
- 5 units
- Product code
- LWS
- FDA submissions
- P980016S713
- 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.
Product description
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Code information (models, lots, serial numbers)
GTIN: 00763000178338, Serial Numbers: RSL607245S, RSL607881S, RSL607883S, RSL607884S, RSL607888S.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cobalt™ XT DR MRI SureScan™ DDPA2D1Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)5 recalls3 deaths241 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94674).
- Z-2191-2024 · Open, ClassifiedCOBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
- Z-2192-2024 · Open, ClassifiedCobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
- Z-2193-2024 · Open, ClassifiedCOBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
- Z-2194-2024 · Open, ClassifiedCOBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
- Z-2195-2024 · Open, ClassifiedCROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
- Z-2208-2024 · Open, ClassifiedCOBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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