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.
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 FDA Class II recall involving a risk-of-harm medical device with potential for serious vascular complications from foreign emboli. However, no illnesses or injuries have been reported, and the hazard is described as a possibility rather than a known occurrence.
Plain-English summary
The Prestige Coil System, manufactured by BALT USA, LLC, is a medical device used to treat peripheral vascular abnormalities by delivering embolic coils through the vasculature to create blood clots and reduce blood flow to abnormal vessels.
This recall involves 2,802 Prestige coils across multiple models. The issue was identified as discoloration on the delivery pusher's hypotube component, caused by corrosion from solder flux residue remaining on the device. Due to the location of the delivery pusher within the delivery system, it is possible for the discolored material to mechanically break off and flow through the delivery system (including the microcatheter) into the patient's blood vessels, potentially causing foreign emboli.
The recalled coils have been distributed in the United States across 28 states plus Puerto Rico, and internationally to 20 countries including Argentina, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Ecuador, France, Indonesia, India, Japan, Korea, Malaysia, Mexico, Panama, Paraguay, Peru, Russia, Uruguay, and Vietnam. A detailed list of lot numbers, model numbers, and product codes is available from the FDA.
Healthcare providers should review records to identify patients who may have received affected devices. Patients who received these devices should contact their healthcare provider with concerns about their procedure. Anyone who experienced symptoms following the procedure should inform their provider of the device recall and seek medical evaluation.
The recalled product
- 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
- Manufacturer
- BALT USA, LLC
- Hazard
- foreign-emboli
- corrosion
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)
- Product model number
Distribution
Distributed in 27 states:
- AZ
- CA
- CO
- FL
- GA
- HI
- IL
- KS
- MA
- ME
- MO
- MS
- NC
- NE
- NH
- NJ
- NY
- OH
- OK
- PA
- SC
- SD
- TN
- TX
- VA
- VT
- WI
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