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ULTRA Detach
BALT USA LLC · Model ULTRA · UDI-DI 00818053029639
HCG
Prescription
10
510(k) clearances
26,296
Adverse events (640 deaths)
68
Recalls
63
Facilities
Description
The ULTRA Detachment Controller is used in conjunction with the Prestige Coil System and separates the coils from the pusher system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-06 | Stryker Neurovascular | Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be |
| 2025-10-02 | Cerenovus Inc | Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention. |
| 2025-05-08 | BALT USA, LLC | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. |
| 2024-01-03 | BALT USA, LLC | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of sold |
| 2022-09-07 | BALT USA, LLC | Product pouch label does not match up with carton label |
| 2022-07-26 | BALT USA, LLC | Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. |
| 2022-04-27 | Micro Therapeutics, Inc. | Due to incorrect size and configuration labeling of the detachable coil system. |
| 2022-01-04 | BALT USA, LLC | 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 mi |
| 2019-11-22 | Microvention, Inc. | The devices may be missing the implant coil. |
| 2019-11-22 | Microvention, Inc. | The devices may be missing the implant coil. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.