# FDA recall Z-1689-2025

> **Boston Scientific Corporation** · Class II · device recall initiated 2025-03-24.

## Product

IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170.  The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

## Reason for recall

Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1689-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-24
- **Report date:** 2025-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1689-2025

## Citation

> AI Analytics. FDA recall Z-1689-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1689-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*