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.
Reported: June 1, 2022 Initiated: April 20, 2022 #Z-1131-2022
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.
Details
- Recalling Firm
- Medtronic Perfusion Systems
- Units Affected
- 1236 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, ND, MA, ID, WI, KS, UT, MN, NY, NJ, GA, MO and the countries of Australia, Belgium, China, Czech Republic, France, Germany, Greece, Israel, Italy, Kazakhstan, Latvia, Netherlands, Poland, Russian Federation, Singapore, Switzerland.
- Location
- Brooklyn Park, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Perfusion Systems. Units affected: 1236 units.
Why was this product recalled? ▼
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 1, 2022. Severity: Moderate. Recall number: Z-1131-2022.
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