Food, drugs, devices › BALT USA, LLC
Device recall: The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a
BALT USA, LLC (Irvine, CA) initiated this device recall on 4 Jan 2022; FDA lists 1 product record under event 89338, classified Class II.
FDA defines Class II as 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. BALT USA, LLC has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
BALT USA, LLC, Irvine, CA.
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…"
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0660-2022 | 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… | 51 devices | Class II | Ongoing | 2 Mar 2022 |
Context
Other enforcement events for BALT USA, LLC
| 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 |
| 8 May 2025 | Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 O | Device | Class II | 2 |
| 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 |
All 6 events for BALT USA, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.