Device recall: Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851…
Class II FDA enforcement event 96787. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Class II, in the words of FDA
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
BALT USA, LLC started this device recall on 8 May 2025. The firm address in the FDA record is in Irvine, CA. FDA put the recall in Class II. FDA event 96787 has 2 product records. The first FDA enforcement report date is 25 Jun 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
BALT USA, LLC, Irvine, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1988-2025 | 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… | 2889 devices | Class II | Ongoing | 25 Jun 2025 |
| Z-1989-2025 | Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 00810068567373 PRES0204CXPPLT 00810068567342… | 1754 devices | Class II | Ongoing | 25 Jun 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Sep 2025 | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT0919 | Device | Class I | 1 |
| 3 Jan 2024 | Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vascu | Device | Class II | 2 |
| 7 Sep 2022 | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures. | Device | Class II | 1 |
| 26 Jul 2022 | Optima Coil System Model OPTI0520CSF10. For endovascular embolization. | Device | Class II | 1 |
| 4 Jan 2022 | The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1988-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 96787. https://recallregister.com/fda/ii/96787/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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,…
- What quantity of product is in FDA event 96787?
- The event has 2 product records. The first record gives this quantity:
2889 devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.