Recall Z-0660-2022 ยท HCG Device, Neurovascular Embolization
BALT USA, LLC
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 Detachm
| Date | Jan 4, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 contac |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200030 | Optima Coil System Balt USA, LLC, Feb 1, 2020 |