# FDA recall Z-1989-2025

> **BALT USA, LLC** · Class II · device recall initiated 2025-05-08.

## 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  PRE

## 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.

## 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.

## Key facts

- **Recall number:** Z-1989-2025
- **Recalling firm:** BALT USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-08
- **Report date:** 2025-06-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1989-2025

## Citation

> AI Analytics. FDA recall Z-1989-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1989-2025. Source: US FDA. Licensed CC0.

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