Optima Coil System embolization coils recalled for defective radiopaque marker
BALT USA is recalling the Optima Coil System because the radiopaque marker was not visible during angiography and was not manufactured to specification.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a device used for critical vascular procedures where visualization is essential to safe placement. The defect (non-visible radiopaque marker) creates a risk of harm during interventional procedures, although no reported illnesses or injuries are stated in the source text, making it a High rather than Severe rating.
Plain-English summary
BALT USA, LLC is recalling the Optima Coil System, an implantable embolization coil used during vascular interventional procedures. The recalled devices include multiple REF codes and configurations of the Optima Coil System and related OptiBLOCK Coil and Optimax Coil products. A total of 2,889 devices have been distributed worldwide, including across numerous U.S. states and to countries including Canada, Australia, Japan, and others.
The recall was initiated because the radiopaque marker on the Optima Coil System was not visible during angiography and was determined to have not been manufactured to specification. The radiopaque marker is a positioning feature intended to aid visualization during medical procedures.
The Optima Coil System is used with the XCEL Detachment Controller and is used in vascular interventional procedures. Patients and healthcare providers who have received or used these devices should contact BALT USA, LLC or their healthcare provider for instructions regarding the recalled devices.
The recalled product
- Product
- Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10…
- Manufacturer
- BALT USA, LLC
- Affected units
- 2,889
Distribution
Part of a larger recall action
This product is one of 2 recalled by BALT USA, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · BALT USA, LLC
See all →- CriticalDistal access catheters recalled after coating material lifting inside the lumen
FDA (Devices) · 2025-11-05
- HighPrestige Coil System implantable devices recalled for manufacturing defect
FDA (Devices) · 2025-06-25
- HighOptima Coil Neurovascular Embolization Devices Risk Foreign Emboli From Corrosion
FDA (Devices) · 2024-02-14
- HighPrestige Coil System Recalled for Risk of Foreign Emboli from Corroded Delivery Pusher
FDA (Devices) · 2024-02-14
- ModerateOptima Coil System Pouch Labels Do Not Match Carton Labels
FDA (Devices) · 2022-10-26
Same hazard · device defect
See all →- SevereBard Access Systems Recalls Power-Trialysis Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
Similar recalls
- HighOptima Coil System Recalled for Labeling and Packaging Mix-Up
FDA (Devices) · 2022-03-02
- HighMedical embolization coil system recalled for untested alternate supplier material
FDA (Devices) · 2022-09-14
- ModerateOptima Coil System Pouch Labels Do Not Match Carton Labels
FDA (Devices) · 2022-10-26
- HighOptima Coil Neurovascular Embolization Devices Risk Foreign Emboli From Corrosion
FDA (Devices) · 2024-02-14
- HighMaquet Recalls Ultima OPCAB Systems Due to Incorrect Blade Labeling
FDA (Devices) · 2013-10-09
- ModerateAngiodynamics Recalls OARTRAC Prostate Balloon Kits Due to Accuracy Issues
FDA (Devices) · 2019-12-25