# FDA recall Z-1042-2024

> **BALT USA, LLC** · Class II · device recall initiated 2024-01-03.

## Product

The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reducing flow into the anomaly, and thrombosing the target site. The Prestige Coil System is comprised of the implant coil and a pusher assembly. There are a total of 81 Prestige coil models. Vascular Embolization Device  Prestige Coil Model Numbers and Product description: PRES0413CPKPL	Prestige Coil 4mm x 13cm	Prestige Plus Complex Pack PRES1137COM18	Prestige Coil 11mm x 37cm	Complex-18 PRES0202CXPPL	Prestige Coil 2mm x 2cm	Prestige Plus Complex Xtra Pac PRES0203CXPPL	Prestige Coil 2mm x 3cm	Prestige Plus Complex Xtra Pac PRES0410CPKPL	Prestige Coil 4mm x 10cm	Prestige Plus Complex Pack PRES0413CPKPL	Prestige Coil 4mm x 13cm	Prestige Plus Complex Pack PRES0315HXPPL	Prestige Coil 3mm x 15cm	Prestige Plus Helical Xt

## Reason for recall

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.

## Distribution

U.S.:  AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI and Puerto Rico  O.U.S.: Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Ecuador, France, Indonesia, India, Japan, Korea, Malaysia, Mexico, Panama, Paraguay, Peru, Russia, Uruguay, and Vietnam.

## Key facts

- **Recall number:** Z-1042-2024
- **Recalling firm:** BALT USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-03
- **Report date:** 2024-02-14

- **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-1042-2024

## Citation

> AI Analytics. FDA recall Z-1042-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1042-2024. Source: US FDA. Licensed CC0.

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