BALT USA recalls Prestige Coil System models due to corrosion of delivery pusher from solder flux residue, which may cause microcatheter blockage and foreign emboli. Affected models include 81 Prestige coil variants with specific model numbers and lot numbers.
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 solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
BALT USA has recalled 81 different Prestige Coil System models because corrosion from solder flux residue on the delivery pusher could break off and travel into the patient's blood vessels, causing blockages. This risk applies to specific coil sizes and packaging.
Corrosion from solder flux residue on the delivery pusher can cause discoloration. This discoloration may mechanically break off, potentially flowing through the delivery system into the patient's blood vessels and causing foreign emboli.
Patients undergoing vascular embolization procedures using the recalled Prestige Coil System models are most at risk. The recall affects medical professionals and facilities that use these specific coil models.
Check for the model numbers listed in the recall, such as PRES0413CPKPL (4mm x 13cm Prestige Plus Complex Pack) or PRES1137COM18 (11mm x 37cm Complex-18). The recall includes 81 specific coil models with associated lot numbers and UDI codes.
Review the model number on your device, such as PRES0413CPKPL or PRES1137COM18, to determine if it is affected.
Corrosion from solder flux residue on the delivery pusher can cause discoloration that may break off and flow into the patient's blood vessels, potentially causing foreign emboli.
81 specific Prestige Coil models are affected, including various sizes and packaging types.
The recall does not specify a remedy, so check the official recall notice for further instructions.
We’ve drafted a message you can send BALT USA to request your refund or repair — edit it as you like.
Subject: Recall Z-1042-2024 — BALT USA BALT USA Hello, I own a BALT USA that is covered by recall Z-1042-2024 from BALT USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
