FDA Medical devices recall · June 25, 2025

Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311… recall

Read the official FDA notice ↗

Product

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.

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Product Description/Product Catalog Number/UDI-DI/Lot Numbers: PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800442 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800505 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800708 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800794 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800513 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800544 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800512 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800538 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800790 PRES1445CPKPLT Prestige 14mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1445CPKPLT 00810068567724 F230800793 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800574 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800575 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra P

Distribution

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.

States: Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Illinois Indiana Kansas Kentucky Massachusetts Maine Minnesota Missouri Mississippi North Carolina North Dakota Nebraska New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1989-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.