The Recall Desk

Manufacturer

BALT USA, LLC

8 recalls in our database name BALT USA, LLC as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
1
Severe
0
Most recent
2025-11-05

Of the 8 recalls from BALT USA, LLC we have scored against our rubric, 1 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • CriticalFDA (Devices)·Z-0188-2026·2025-11-05

    Distal access catheters recalled after coating material lifting inside the lumen

    Balt USA is recalling 207 MEGA Ballast Distal Access Platform catheters over a manufacturing defect in which coating material lifts within the catheter's distal lumen. The FDA has classified it Class I.

    Product
    Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flex
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1989-2025·2025-06-25

    Prestige Coil System implantable devices recalled for manufacturing defect

    BALT USA is recalling Prestige Coil System implantable embolization devices because radiopaque markers on some units were not manufactured to specification and were not visible during angiography.

    Product
    Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 0081006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2025·2025-06-25

    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.

    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 008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2024·2024-02-14

    Prestige Coil System Recalled for Risk of Foreign Emboli from Corroded Delivery Pusher

    BALT USA is recalling Prestige Coil Systems due to corrosion of the delivery pusher. Solder flux residue can cause the discolored hypotube to break off and enter patient blood vessels as foreign emboli.

    Product
    The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reduc
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1041-2024·2024-02-14

    Optima Coil Neurovascular Embolization Devices Risk Foreign Emboli From Corrosion

    BALT's Optima Coil neurovascular embolization devices may have corroded solder flux residue on the delivery pusher that could break off and cause foreign emboli in patient blood vessels.

    Product
    Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant com
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-0103-2023·2022-10-26

    Optima Coil System Pouch Labels Do Not Match Carton Labels

    BALT USA is recalling Optima Coil System models OPTI0208CSS10 and OPTI0308CSS10 due to a labeling discrepancy where pouch labels do not match carton labels. These endovascular devices require verification before use.

    Product
    Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1680-2022·2022-09-14

    Medical embolization coil system recalled for untested alternate supplier material

    BALT USA recalls the Optima Coil System because devices were distributed with material from an alternate supplier before required testing was approved. No illnesses or injuries have been reported.

    Product
    Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0660-2022·2022-03-02

    Optima Coil System Recalled for Labeling and Packaging Mix-Up

    BALT USA recalls Optima Coil System embolization devices due to labeling/pouch mix-up that could result in incorrect device selection during surgical procedures. Potential harms include vessel damage and aneurysm rupture.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide