FDAFDA · Food and drugs·Recall number Z-1131-2022
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.
Published June 1, 2022 · Recall initiated: April 20, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Perfusion Systems
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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