Recall Z-1131-2022 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Medtronic Perfusion Systems
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.
| Date | Apr 20, 2022 |
| Status | Open, Classified |
| Reason | Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. |
| Root cause | 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 | 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, Switzerl |
| FDA record | Open on fda.gov |