Prestige Coil embolization coils recalled for defective radiopaque markers
Prestige Coil System embolization coils are recalled due to faulty radiopaque markers that are not visible during angiography. The defect may impair physician visualization during coil placement.
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 a risk-of-harm medical device (implantable coil) with a manufacturing defect affecting the radiopaque marker. It is classified as FDA Class II. No injuries or illnesses are reported in the source material, placing it at High severity rather than Severe.
Plain-English summary
The Prestige Coil System is an implantable embolization coil device consisting of a platinum-tungsten alloy coil attached to a stainless steel hypotube and delivery pusher with a radiopaque marker.
The FDA has issued a recall for certain Prestige Coil System devices due to a manufacturing defect in the radiopaque marker. The marker is not visible during angiography imaging because it was not manufactured to specification.
Approximately 1,754 affected devices have been distributed worldwide, including across the United States and numerous other countries. Patients and healthcare providers with these devices should contact BALT USA, LLC, the manufacturer, for information about identifying affected devices and determining next steps.
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
- visibility-defect
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
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