Recall Z-1131-2022— Medtronic Perfusion Systems
Class II · Ongoing
Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2022-04-20. It names 2 FDA 510(k) clearances: K200514, K121767. 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..
- Recalling firm
- Medtronic Perfusion Systems
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-04-20
- Firm location
- Brooklyn Park, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K200514 — Cardioblate Gemini-s Surgical Ablation Device
- K121767 — CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.