Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System — Class II medical device recall Z-1131-2022
Ongoing recall by Medtronic Perfusion Systems, reported 2022-06-01, distributed nationwide. Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
| Recall number | Z-1131-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2022-04-20 |
| Classified | 2022-05-25 |
| Reported by FDA | 2022-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, CN, CZ, DE, FR, GR, IL, IT, LV, NL, PL, SG |
| Quantity | 1,236 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00613994268051, 00613994755643, 00643169983120, 00643169998117 |
| Lot numbers | 125E, 238D, 256E, 257E, 258E, 259E, 335D, 373B, 388C, 410E, 428D, 454F, 466C, 467C, 469C, 495F, 584D, 585D, 611A, 612A, 632E, 635F, 700D, 721C, 722C, 732E, 734E, 735E, 738E, 745F, 840C, 841C, 846D, 850C, 876E, 923D, 967C, 968C, 972C, 972E and 3 more |
| Model numbers | 49260, 49351 |
Product
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
Reason for recall
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
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-1131-2022. 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.