Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK…
Medical device recall Z-1988-2025. Published in FDA’s Enforcement Report on Jun 25, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 25, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 39 states named
- 2889 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 00818053026614 OPTI0152HSS10 00840303701002 OPTI0153HSS10 00840303701019 OPTI0154CSS10 00818053025761 OPTI0154HSS10 00840303701026 OPTI1027CST10 00840303700142 OPTI1030HST10 00818053027086 OPTI1034COM18 00818053026461 OPTI1137COM18 00818053026478 OPTI1550COM18 00818053026515 OPTI0101CSS10 00818053025709 OPTI0101HSS10 00840303700951 OPTI0102CSS10 00818053025716 OPTI0102HSS10 00840303700968 OPTI0103HSS10 00818053026591 OPTI0103CSS10 00818053025723 OPTI0104HSS10 00818053026607 OPTI0254CSS10 00840303700548 OPTI0255CSF10 00840303700203 OPTI0256CSS10 00818053025853 OPTI0256HSS10 00818053026737 OPTI0202HSS10 00840303701040 OPTI0203HSS10 00840303701057 OPTI0203CSS10 00818053025785 OPTI0204CSS10 00840303700494 OPTI0204HSS10 00840303701064 OPTI0206CSF10 00818053026027 OPTI0206CSS10 00818053025808 OPTI0208CSF10 00818053026034 OPTI0208HSS10 00840303701088 OPTI0208CSS10 00840303700517 OPTI0358CSS10 00818053025921 OPTI0310HSS10 00840303701156 OPTI0310CSS10 00818053025907 OPTI0310HSF10 00840303700814 OPTI0310CSF10 00840303700234 OPTI0304HSS10 00840303701125 OPTI0304HSF10 00840303700784 OPTI0304CSS10 00818053025877 OPTI0306HSS10 00840303701132 OPTI0308HSS10 00840303701149 OPTI0308CSF10 00818053026065 OPTI0308CSS10 00840303700593 OPTI0410CSS10 00840303700654 OPTI0410HSF10 00840303700852 OPTI0413CSF10 00818053026119 OPTI0406HSS10 00840303701163 OPTI0408HSS10 00818053026799 OPTI0413CST10 00840303700036 OPTI0510HSS10 00840303701217 OPTI0510CSS10 00840303700685 OPTI0510HSF10 00840303700890 OPTI0513CSS10 00840303700692 OPTI0517CSF10 00818053026157 OPTI0517CST10 00840303700050 OPTI0508CSS10 00840303700678 OPTI0509CSF10 00818053026140 OPTI0610HSF10 00840303700937 OPTI0611CSF10 00818053026171 OPTI0620CSF10 00840303700357 OPTI0620HST10 00840303700715 OPTI0713CST10 00840303700081 OPTI0713CSF10 00840303700364 OPTI0724CSF10 00818053026218 OPTI0724CST10 00840303700098 OPTI0724COM18 00818053026430 OPTI0827CSF10 00818053026232 OPTI0827CST10 00840303700111 OPTI0923CST10 00818053026379 OPTI0930COM18 00818053026454 OPTI0153HSSMX 00818053025419 OPTI1040CSFMX 00818053025280 OPTI1245CSFMX 00818053025303 OPTI1445CSFMX 00818053025327 OPTI1650CSFMX 00818053025341 OPTI0103CSSMX 00840303701408 OPTI2525CSSMX 00840303701477 OPTI0255CSSMX 00818053025020 OPTI0202CSSMX 00818053024979 OPTI3535CSSMX 00818053025068 OPTI0310CSSMX 00818053025051 OPTI0307CSSMX 00818053025044 OPTI4510CSFMX 00818053025143 OPTI4545CSFMX 00818053025136 OPTI0413CSFMX 00818053025129 OPTI0404CSFMX 00818053025099 OPTI0407CSFMX 00818053025105 OPTI0510CSFMX 00818053025167 OPTI0507CSFMX 00818053025150 OPTI0715CSFMX 00818053025228 OPTI0720CSFMX 00818053025235 OPTI0930CSFMX 00818053025266 The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a 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 be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.
2889 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Description/Product Catalog Number/UDI-DI/Lot Numbers: OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800439 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800506 OptiBLOCK…
Every code shown here, 1,995 characters
Product Description/Product Catalog Number/UDI-DI/Lot Numbers: OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800439 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800506 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800507 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800579 OptiBLOCK Coil 1.5mm x 6cm OptiBLOCK Complex OPTI0156BLK 00810068568875 F230800885 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800480 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800581 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800722 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800857 OptiBLOCK Coil 1.5mm x 8cm OptiBLOCK Complex OPTI0158BLK 00810068568882 F230800858 OptiBLOCK Coil 1mm x 3cm OptiBLOCK Complex OPTI0103BLK 00810068568851 F230800854 OptiBLOCK Coil 1mm x 3cm OptiBLOCK Complex OPTI0103BLK 00810068568851 F230800855 OptiBLOCK Coil 2.5mm x 8cm OptiBLOCK Complex OPTI0258BLK 00810068568929 F230800768 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800514 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800525 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800577 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800770 OptiBLOCK Coil 2mm x 12cm OptiBLOCK Complex OPTI0212BLK 00810068568912 F230800887 OptiBLOCK Coil 2mm x 6cm OptiBLOCK Complex OPTI0206BLK 00810068568905 F230800478 OptiBLOCK Coil 3mm x 10cm OptiBLOCK Complex OPTI0310BLK 00810068568943 F230800497 OptiBLOCK Coil 3mm x 20cm OptiBLOCK Complex OPTI0320BLK 00810068568950 F230800760 OptiBLOCK Coil 3mm x 20cm OptiBLOCK Complex OPTI0320BLK 00810068568950 F230800856 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft OPTI0151HSS10 00818053026614 F230800784 Optima Coil 1.5mm x 2cm Helical-10…
FDA’s list runs to 17,984 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WI. The countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Greece, India, Indonesia, Iraq, Italy, Japan, Jordan, Kazakhstan, Korea, Kyrgyzstan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Peru, Poland, Portugal, Romania, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, and Vietnam.
The states and territories these words name
39 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maine
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 8, 2025.
- FDA classified it on Jun 18, 2025.
- FDA’s Enforcement Report published it on Jun 25, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- BALT USA, LLC, of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 17,984 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.