# FDA recall Z-2624-2026

> **Medtronic Heart Valves Division** · Class I · device recall initiated 2026-05-22.

## Product

Medtronic Harmony Delivery Catheter System

## Reason for recall

Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Mexico, Netherlands, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

## Key facts

- **Recall number:** Z-2624-2026
- **Recalling firm:** Medtronic Heart Valves Division
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-22
- **Report date:** 2026-07-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2624-2026

## Citation

> MORVS. FDA recall Z-2624-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2624-2026. Source: US FDA. Licensed CC0.

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