The Optima Coil System consists of an implantable recall: Labeling Error
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel…
Why was The Optima Coil System consists of an implantable recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/REF: OPTI0204CSF10 Lot Number: F210500134 UDI Code: 00818053026010 Model/REF: OPTI0407CSF10 Lot Number: F210500135 UDI Code: 00818053026096
- Product
- The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel…
- Recalling firm
- BALT USA, LLC
- 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.
- Recall date
- March 2, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)