Z-1131-2022 Class II Ongoing
FDA device recall Z-1131-2022 was initiated by Medtronic Perfusion Systems on Apr 20, 2022 and is designated Class II. Reason for recall: Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. The recall status is ongoing. Affected quantity: 1236 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 1, 2022
- Initiation Date
- Apr 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1236 units
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.
Distribution Pattern
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1131-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026