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RecallWatchMedical Device Safety
Class IIOngoingZ-1989-2025

BALT USA, LLC recalls Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT…

BALT USA, LLCIrvine, CA, United StatesReported Jun 25, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 00810068567373 PRES0204CXPPLT 00810068567342 PRES0206CXPPLT 00810068567359 PRES0208CXPPLT 00810068567366 PRES3520CXPPLT 00810068567441 PRES3530CXPPLT 00810068567458 PRES0310CXPPLT 00810068567403 PRES0320CXPPLT 00810068567410 PRES0420CPKPLT 00810068567489 PRES0517CPKPLT 00810068567519 PRES0540CPKPLT 00810068568028 PRES0620CPKPLT 00810068567557 PRES0635CPKPLT 00810068567564 PRES0650CPKPLT 00810068567571 PRES0720CPKPLT 00810068567588 PRES0735CPKPLT 00810068567595 PRES0750CPKPLT 00810068567601 PRES0830CPKPLT 00810068567618 PRES0845CPKPLT 00810068567625 PRES0153HXPPL 00818053027147 PRES0204HXPPL 00818053029943 PRES0204CXPPL 00818053027321 PRES0208HXPPL 00818053029981 PRES0315HXPPL 00818053027178 PRES0307CXPPL 00818053027376 PRES0420HPKPL 00818053027185 PRES0440HPKPL 00810068567830 PRES0520HPKPL 00818053027192 PRES0540HPKPL 00810068567847 PRES0650HPKPL 00810068567854 PRES0720HPKPL 00818053027215 PRES0750HPKPL 00810068567861 PRES0830HPKPL 00818053027222 The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately
    Catalog # Number/UDI-DI/Lot
    400 affected lots
    PRES0153CXPPLT1.5mm3cmPRES0153CXPPLT00810068567311F230800442PRES0153CXPPLT1.5mm
    +392 more3cmPRES0153CXPPLT00810068567311F230800505PRES0153CXPPLT1.5mm3cmPRES0153CXPPLT00810068567311F230800708PRES0153CXPPLT1.5mm3cmPRES0153CXPPLT00810068567311F230800794PRES1045CPKPLT10mm45cmPRES1045CPKPLT00810068567663F230800513PRES1045CPKPLT10mm45cmPRES1045CPKPLT00810068567663F230800544PRES1245CPKPLT12mm45cmPRES1245CPKPLT00810068567694F230800512PRES1245CPKPLT12mm45cmPRES1245CPKPLT00810068567694F230800538PRES1245CPKPLT12mm45cmPRES1245CPKPLT00810068567694F230800790PRES1445CPKPLT14mm45cmPRES1445CPKPLT00810068567724F230800793PRES0103CXPPLT1mm3cmPRES0103CXPPLT00810068567304F230800574PRES0103CXPPLT1mm3cmPRES0103CXPPLT00810068567304F230800575PRES0103CXPPLT1mm3cmPRES0103CXPPLT00810068567304F230800576PRES0103CXPPLT1mm3cmPRES0103CXPPLT00810068567304F230800947PRES2512CXPPLT2.5mm12cmPRES2512CXPPLT00810068567397F230800549PRES2512CXPPLT2.5mm12cmPRES2512CXPPLT00810068567397F230800759PRES0258CXPPLT2.5mm8cmPRES0258CXPPLT00810068567380F230800833PRES0212CXPPLT2mm12cmPRES0212CXPPLT00810068567373F230800515PRES0212CXPPLT2mm12cmPRES0212CXPPLT00810068567373F230800527PRES0212CXPPLT2mm12cmPRES0212CXPPLT00810068567373F230800578PRES0212CXPPLT2mm12cmPRES0212CXPPLT00810068567373F230800791PRES0212CXPPLT2mm12cmPRES0212CXPPLT00810068567373F230800941PRES0204CXPPLT2mm4cmPRES0204CXPPLT00810068567342F230800454PRES0204CXPPLT2mm4cmPRES0204CXPPLT00810068567342F230800546PRES0204CXPPLT2mm4cmPRES0204CXPPLT00810068567342F230800771PRES0204CXPPLT2mm4cmPRES0204CXPPLT00810068567342F230800888PRES0206CXPPLT2mm6cmPRES0206CXPPLT00810068567359F230800479PRES0206CXPPLT2mm6cmPRES0206CXPPLT00810068567359F230800580PRES0206CXPPLT2mm6cmPRES0206CXPPLT00810068567359F230800715PRES0206CXPPLT2mm6cmPRES0206CXPPLT00810068567359F230800938PRES0206CXPPLT2mm6cmPRES0206CXPPLT00810068567359F241100052PRES0208CXPPLT2mm8cmPRES0208CXPPLT00810068567366F230800940PRES0208CXPPLT2mm8cmPRES0208CXPPLT00810068567366F230800949PRES3520CXPPLT3.5mm20cmPRES3520CXPPLT00810068567441F230800418PRES3520CXPPLT3.5mm20cmPRES3520CXPPLT00810068567441F230800529PRES3530CXPPLT3.5mm30cmPRES3530CXPPLT00810068567458F230800482PRES3530CXPPLT3.5mm30cmPRES3530CXPPLT00810068567458F230800483PRES3530CXPPLT3.5mm30cmPRES3530CXPPLT00810068567458F230800769PRES0310CXPPLT3mm10cmPRES0310CXPPLT00810068567403F230800504PRES0310CXPPLT3mm10cmPRES0310CXPPLT00810068567403F230800763PRES0320CXPPLT3mm20cmPRES0320CXPPLT00810068567410F230800441PRES0420CPKPLT4mm20cmPRES0420CPKPLT00810068567489F230800795PRES0420CPKPLT4mm20cmPRES0420CPKPLT00810068567489F230800796PRES0517CPKPLT5mm17cmPRES0517CPKPLT00810068567519F230800451PRES0517CPKPLT5mm17cmPRES0517CPKPLT00810068567519F230800664PRES0517CPKPLT5mm17cmPRES0517CPKPLT00810068567519F230800797PRES0517CPKPLT5mm17cmPRES0517CPKPLT00810068567519F230800831PRES0540CPKPLT5mm40cmPRES0540CPKPLT00810068568028F230800822PRES0540CPKPLT5mm40cmPRES0540CPKPLT00810068568028F230800886PRES0540CPKPLT5mm40cmPRES0540CPKPLT00810068568028F241200132PRES0620CPKPLT6mm20cmPRES0620CPKPLT00810068567557F230800458PRES0620CPKPLT6mm20cmPRES0620CPKPLT00810068567557F230800517PRES0635CPKPLT6mm35cmPRES0635CPKPLT00810068567564F230800511PRES0635CPKPLT6mm35cmPRES0635CPKPLT00810068567564F230800519PRES0635CPKPLT6mm35cmPRES0635CPKPLT00810068567564F230800766PRES0650CPKPLT6mm50cmPRES0650CPKPLT00810068567571F230800821PRES0720CPKPLT7mm20cmPRES0720CPKPLT00810068567588F230800440PRES0720CPKPLT7mm20cmPRES0720CPKPLT00810068567588F230800510PRES0735CPKPLT7mm35cmPRES0735CPKPLT00810068567595F230800518PRES0735CPKPLT7mm35cmPRES0735CPKPLT00810068567595F230800537PRES0735CPKPLT7mm35cmPRES0735CPKPLT00810068567595F230800818PRES0735CPKPLT7mm35cmPRES0735CPKPLT00810068567595F230900021PRES0750CPKPLT7mm50cmPRES0750CPKPLT00810068567601F230800444PRES0750CPKPLT7mm50cmPRES0750CPKPLT00810068567601F230800509PRES0750CPKPLT7mm50cmPRES0750CPKPLT00810068567601F230800665PRES0830CPKPLT8mm30cmPRES0830CPKPLT00810068567618F230800516PRES0845CPKPLT8mm45cmPRES0845CPKPLT

What the firm is doing

On 05/08/2025, the firm sent via priority mail and an, "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that defect impacting specific lots of the Optima and Prestige Coil Systems, in which the distal 3 cm radiopaque (RO) marker may not be visible under fluoroscopy. Customers are instructed to: As a voluntary alternative to returning the affected products, devices from the affected lots can be inspected by trained hospital personnel for the presence of the RO marker using available fluoroscopy imaging equipment prior to a clinical procedure. It is important to conduct this inspection as soon as possible. The image is achieved by taking the fluoroscopic image of the coil system within the unopened box. 1) If the image contains the RO marker, as exemplified from Figure 1, i. Complete the Notice of Receipt (refer to the annex on page 5) indicating the verified results. ii. Mark the inspected boxes with the date and time of the fluoroscopy test and the name of the person performing the test. iii. Return the product back to your inventory with no further action required. iv. Send the completed Notice of Receipt to Balt USA at QA@baltgroup.com. 2) If the image does not contain the RO marker from Figure 2 or if the RO marker is not visually discernable, contact Balt USA at QA@baltgroup.com to process the return of the product. If customers desire to return the products: Distribution agents or Hospital Staff: -Identify and locate the affected Coil System and cease all use of the affected product(s). -For returning collect and put in quarantine and then return them to Balt USA through the usual RMA procedure by contacting our Customer Service. -Contact Balt USA at QA@baltgroup.com or phone +949-788-1443.

DistributionShow details

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WI. The countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Greece, India, Indonesia, Iraq, Italy, Japan, Jordan, Kazakhstan, Korea, Kyrgyzstan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Peru, Poland, Portugal, Romania, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, and Vietnam.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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