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.
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 of an implantable medical device where a critical component (radiopaque marker) was not visible during angiography due to manufacturing defect. Although no reported injuries are stated, the inability to visualize the marker during the angiographic procedure presents a risk of harm to patients, justifying a High severity rating per the rubric.
Plain-English summary
BALT USA, LLC is recalling Prestige Coil System implantable embolization coil devices due to a manufacturing defect affecting the radiopaque (RO) marker. The RO marker was not visible during angiography, indicating that the marker was not manufactured to specification.
The Prestige Coil System is an implantable medical device consisting of a platinum-tungsten alloy coil attached to a proximal stainless steel hypotube and delivery pusher with radiopaque and fluorosafe markers. The device is designed for use with the XCEL Detachment Controller. Approximately 1,754 devices have been distributed worldwide, including throughout the United States and internationally to countries including Canada, Mexico, Japan, Australia, and others.
The affected product includes multiple catalog numbers (REFs) and UDI-DI codes as listed by the FDA, spanning various coil sizes. Healthcare providers who have received or used these devices should contact BALT USA regarding potential replacement or remediation options.
The recalled product
- Product
- Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 0081006
- Manufacturer
- BALT USA, LLC
- Hazard
- manufacturing-defect
- visibility-marker
Distribution
Distributed nationwide across the United States.
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