BALT USA recalls Prestige Coil System models with specific REFs/UDI-DI codes due to radiopaque marker not being visible during angiography, potentially affecting medical procedures.
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
BALT USA is recalling specific models of Prestige Coil System medical devices because the radiopaque marker used for imaging during procedures wasn't visible as it should be. This could lead to incorrect placement during angiography.
The radiopaque marker is a visible marker that helps doctors see where the coil is placed during imaging. If it's not visible as it should be, doctors might place the coil incorrectly during angiography procedures, which could cause complications.
Patients who have received the recalled Prestige Coil System models for medical procedures are at risk. Healthcare providers using these devices for angiography may need to check if their equipment is affected.
Check for the specific REFs/UDI-DI codes listed in the recall: PRES0153CXPPLT, PRES1045CPKPLT, PRES1245CPKPLT, etc. These codes are found on the product packaging or device labels.
Look for the specific REFs/UDI-DI codes listed in the recall on the product packaging or device labels.
The radiopaque marker was not visible during angiography, which could lead to incorrect placement of the coil during medical procedures.
The affected models include Prestige Coil System with REFs/UDI-DI codes: PRES0153CXPPLT, PRES1045CPKPLT, PRES1245CPKPLT, and others listed in the recall.
The recall does not specify a stop-use instruction; only checking the product codes is mentioned.
We’ve drafted a message you can send BALT USA to request your refund or repair — edit it as you like.
Subject: Recall Z-1989-2025 — BALT USA BALT USA Hello, I own a BALT USA that is covered by recall Z-1989-2025 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.
