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.
What this means for you
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 where an existing material from an alternate supplier was used before required testing was approved. Although no illnesses or injuries have been reported, untested material in a medical device for vascular intervention represents a risk-of-harm scenario. Per the severity rubric, risk-of-harm products where injury has not yet been reported score High (3).
Plain-English summary
BALT USA, LLC is recalling the Optima Coil System Model OPTI0520CSF10, a device used for endovascular embolization. Four units were distributed in Arizona and Florida.
The recalled devices were released to customers before approval and release of a test report authorizing use of material from an alternate supplier. Specifically, the devices contained an existing material sourced from a new supplier, but the required test report for this supplier's material was not approved prior to distribution.
No illnesses or injuries have been reported. Healthcare facilities and providers who received this device should contact BALT USA, LLC. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
- Manufacturer
- BALT USA, LLC
- Hazard
- untested-supplier-material
- regulatory-violation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470
Distribution
Distributed in 2 states:
- AZ
- FL
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