FDA Device recall Z-2192-2024
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
- FDA Device
- Class II
- ongoing
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class II recall of Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator by Medtronic, citing potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2192-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-16 |
| Published | 2024-07-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
Reason
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Identifiers
| code_info | GTIN: 00763000178130, Serial Numbers: RTG612496S, RTG612497S, RTG612498S, RTG612499S, RTG612502S, RTG612503S, RTG612504…GTIN: 00763000178130, Serial Numbers: RTG612496S, RTG612497S, RTG612498S, RTG612499S, RTG612502S, RTG612503S, RTG612504S, RTG612505S, RTG612509S, RTG612512S, RTG612513S, RTG612549S, RTG612553S, RTG612556S. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2192-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.