Class 2 Device Recall Optima Coil System Complex10 Soft Endovascular Embolization Coil

• Date Initiated by Firm: January 04, 2022
• Create Date: February 22, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0660-2022
• Recall Event ID: 89338
• 510(K)Number: K200030
• Product Classification: Device, neurovascular embolization - Product Code HCG
• Product: The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. it is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Optima Coil System and XCEL Detachment Controller(s) are sold separately. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller.
• Code Information: Model/REF: OPTI0204CSF10 Lot Number: F210500134 UDI Code: 00818053026010 Model/REF: OPTI0407CSF10 Lot Number: F210500135 UDI Code: 00818053026096
• Recalling Firm/ Manufacturer: BALT USA, LLC; 29 Parker Ste 100; Irvine CA 92618-1667
• For Additional Information Contact: Moises Colin; 949-788-1443 Ext. 765
• Manufacturer Reason for Recall: Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.
• FDA Determined Cause: Process control
• Action: On 01/04/2022, the firm sent an "URGENT FIELD SAFETY NOTICE (FSN)/PRODUCT RECALL" letter via email to customers notifying them of the labeling mix-up which presents a high risk to patient safety and product performance, with the possibility that the user could inadvertently select the wrong size coil for a procedure. Customer/Distributors are instruction to: -Inform their customers about the notice; -Identify and locate the affected products -Collect and put in quarantine the affected products and return them to the Recalling Firm through the Return Material Authorization procedure by contacting the Recalling Firm's Customer Service Department. -Inform the Recalling Firm about the status of every unit of the affected products. -Fulfill the Notice of receipt then return to the Recall Firm via the indicated contact For Hospital Staff: -Within their hospital, inform all Safety Officers, Pharmacists, Head of Neuroradiology and the Neuroradiology Department Staff as well as any other person if deemed necessary. -Identify and locate all affected products and cease or stop using. -Collect and put in quarantine all affected products and return them to their local distributor as per its return procedure; -Inform their local distributor and the Recalling Firm about the status of every unit of affected product. -Contact their local distributor or the Recalling Firm for any additional informaiton. For questions or assistance, contact Quality Department at: email QA@balt-usa.com address: 29 Parker Suite 100, Irvine CA 92618, USA Telephone number: 949-788-1443 or Fax 949-788-1444
• Quantity in Commerce: 51 devices
• Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of FL and MD. The countries of Denmark, France, Germany, Lebanon, Netherlands, Sweden, Peru, Portugal, Slovenia, Spain, and United Arab Emirates.
• 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 = HCG