Reported Mar 2, 2022 · Ongoing
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to…
Balt USA, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BALT USA, LLC · 29 Parker Ste 100 · Irvine, CA · 92618-1667
Is this the product you have?
- 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 codes and dates
- Model/REFOPTI0204CSF10
- Lot NumberF210500134
- UDI Code00818053026010
- Model/REFOPTI0407CSF10
- Lot NumberF210500135
- UDI Code00818053026096
- Amount recalled
- 51 devices
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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