Reported Feb 14, 2024 · Ongoing
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the…
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?
55 of 55 products
| Model / number | Product as published |
|---|---|
Complex-10 | Coil 1mm x 1cm |
Complex-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Helical-10 | Coil 1mm x 1cm |
Complex-10 | Coil 1mm x 2cm |
Complex-10 | Coil 1mm x 2cm |
Complex-10 | Coil 1mm x 2cm |
Complex-10 | Coil 1mm x 2cm |
- Lot codes and dates
108 of 108 products
Products covered by this recall Model / number Barcodes Product as published Complex-1800818053021978F200800231 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F201000062 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F201000304 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F201000492 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F201001117 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F201001152 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F201100194 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053026409 F201100273 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F201100341 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F201100591 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053026409 F201200364 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F201200724 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053026409 F201200747 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053026409 F201200796 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053026409 F201200798 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053026409 F201200801 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053026409 F201200802 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 8.18053E+11 F201201160 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F201201176 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053026409 F210100970 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F210200038 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053021923 F210200089 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053026409 F210200392 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053021978F210200393 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F210200406 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F210200435 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F210200442 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053021978F210200536 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F210300190 OPTI1034COM18 Optima Coil 10mm x 34cm Complex-1800818053026461F210301077 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053021923 F210500127 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053026409 F210601110 OPTI1034CST10 Optima Coil 10mm x 34cm Complex-10 Standard 00818053021923 F200700303 OPTI1137COM18 Optima Coil 11mm x 37cm Complex-1800818053021985F200800232 OPTI1137COM18 Optima Coil 11mm x 37cm - Amount recalled
- 31785 coils
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
This product could cause temporary or reversible health problems — stop using it.
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