The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a
Summary
The FDA issued a Class II for The Optima Coil System consists of an implantable embolization coil comprised of by BALT USA, LLC. Reason: Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. A.
Details
Source
Device Recall
External ID
Z-0660-2022
Action Date
2022-03-02
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model/REF: OPTI0204CSF10 Lot Number: F210500134 UDI Code: 00818053026010 Model/REF: OPTI0407CSF10 Lot Number: F210500135 UDI Code: 00818053026096
Quantity Affected: 51 devices
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-04
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BALT USA, LLC has 20 FDA actions in our database, including 8 recalls and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BALT USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BALT USA, LLC have FDA actions?
BALT USA, LLC has 20 FDA actions in our database, including 8 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0660-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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