FDA Device recall Z-1131-2022
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System
- FDA Device
- Class II
- ongoing
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System by Medtronic Perfusion Systems, citing firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1131-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-20 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
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
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Identifiers
| code_info | ABLATION DEVICE 49260 PROCEDURE KIT Model 49260; GTIN: 00613994268051, Lot Numbers: 215G, 256E, 388C, 466C, 584D, 611A,…ABLATION DEVICE 49260 PROCEDURE KIT Model 49260; GTIN: 00613994268051, Lot Numbers: 215G, 256E, 388C, 466C, 584D, 611A, 745F, 840C, 850C, 967C; GTIN: 00613994755643, Lot Numbers: 469C, 612A, 972C, 973C, GTIN: 00643169983120, Lot Numbers: 125E, 238D, 257E, 258E, 259E, 335D, 373B, 410E, 428D, 454F, 467C, 585D, 632E, 635F, 700D, 721C, 722C, 732E, 735E, 738E, 841C, 876E, 923D, 968C, 972E, 980E, 995D. CLAMP 49351 CARDIOBLATE GEMINI-S FT Model: 49351; GTIN: 00643169998117, Lot Numbers: 495F, 734E, 846D. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1131-2022%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.