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
Check against the official notice below — it lists the full affected range.
BALT USA, LLC is recalling its Optima Coil System, an implantable medical device used for embolization procedures. The recall affects 51 devices across two lot numbers due to labeling mix-ups caused by inadequate manufacturing line clearance, resulting in pouches and cartons with incorrect labels. This labeling error could cause healthcare providers to inadvertently select the wrong coil size during a procedure.
The potential harms from selecting an incorrect coil size include vessel damage, inability to treat the patient with the device, and potential rupture of an aneurysm. The affected devices were distributed worldwide, including nationwide distribution in Florida and Maryland, as well as in Denmark, France, Germany, Lebanon, the Netherlands, Sweden, Peru, Portugal, Slovenia, Spain, and the United Arab Emirates. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 51 devices Lot/code info: Model/REF: OPTI0204CSF10 Lot Number: F210500134 UDI Code: 00818053026010 Model/REF: OPTI0407CSF10 Lot Number: F210500135 UDI Code: 00818053026096
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.