Product not distributed in the US — Class II medical device recall Z-2212-2024
Ongoing recall by Medtronic Inc., reported 2024-07-03, distributed nationwide. Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
| Recall number | Z-2212-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Mounds View, MN, United States |
| Recall initiated | 2024-04-16 |
| Classified | 2024-06-26 |
| Reported by FDA | 2024-07-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BG, CA, CH, CN, CZ, DE, ES, FR, GB, GR, HR, IE, IS, IT, JO, LV, NL, NO, OM, PA, PL, PT, QA, SE, SI, SK |
| Quantity | 82 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00763000206147, 00763000206222, 00763000206246, 00763000206253, 00763000206260, 00763000206284, 00763000206291, 00763000206307, 00763000206338, 00763000206352, 00763000611835, 00763000612191, 00763000612269 |
| Serial numbers | BLG628370S, BLG628372S, BLG628373S, CWH606546S, CWH606548S, CWH606551S, CWH606552S, CWH606553S, PGZ663023S, PGZ663203S, PGZ663208S, PGZ663211S, PGZ663216S, PGZ663219S, PGZ663241S, PGZ663264S, PLX622054S, PLX622056S, PLX622072S, PMX622050S, PMX622052S, PMX622055S, PMX622056S, PMX622057S, PMX622059S and 57 more |
| Model numbers | DDMB2D4, DTBA2QQ, DTMA2D1, DTMA2QQ, DTMB2D1, DTMB2D4, DTMB2Q1, DTMB2QQ, DTMC2QQ, DVFB2D1, DVFB2D4, DVFC3D4 |
Product
Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD CRT-D SureScan, Model Number DTMC2QQ. i. EVERA MRI XT DR SureScan, Model Number DDMB2D4. j. VISIA AF MRI XT VR SureScan, Model Number DVFB2D1. k. VISIA AF MRI S VR SureScan, Model Number DVFC3D4. l. VISIA AF MRI XT VR SureScan, Model Number DVFB2D4.
Reason for recall
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2212-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.