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U.S. Department of Health and Human Services

Class 2 Device Recall Cardioblate"Gemini"

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  Class 2 Device Recall Cardioblate"Gemini" see related information
Date Initiated by Firm April 20, 2022
Create Date May 25, 2022
Recall Status1 Open3, Classified
Recall Number Z-1131-2022
Recall Event ID 90089
510(K)Number K121767  K200514  
Product Classification Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue - Product Code OCL
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.
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.
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Medtronic Customer Service
1800-854-3570
Manufacturer Reason
for Recall		 Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
FDA Determined
Cause 2		 Labeling design
Action A recall notification was sent to consignees on 04/20/2022 via the United Parcel Service. The letter instructs the consignees to review the updated guidance on device usage contained in the letter, share the notice to those that need to be aware, and complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OCL and Original Applicant = Medtronic
510(K)s with Product Code = OCL and Original Applicant = MEDTRONIC INC.
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