# FDA recall Z-1383-2024

> **Bolton Medical Inc.** · Class II · device recall initiated 2024-02-22.

## Product

RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile:    (a) Part number 28-M4-34-100-34U;  (b) Part number 28-M4-30-095-30U;  (c) Part number 28-M4-46-155-46U;  (d) Part number 28-M4-32-155-32S;  (e) Part number 28-M4-36-250-32S;  (f) Part number 28-M4-38-145-34S;  (g) Part number 28-M4-38-190-38S;  (h) Part number 28-M4-44-105-44S;  (i) Part number 28-N4-22-099-22S;  (j) Part number 28-N4-22-159-22S;  (k) Part number 28-N4-24-099-24S;  (l) Part number 28-N4-28-204-24S	  (m) Part number 28-N4-30-164-30U;  (n) Part number 28-N4-32-164-28S;  (o) Part number 28-N4-34-154-34U;  (p) Part number 28-N4-34-209-30S;  (q) RELAY PRO Custom-Made Device, REF 28NC36N19038S2590, part number 28-CMP-3062-NC; and  (r) RELAY PRO Custom-Made Device, REF 28MC36A17536S2390, part number 28-CMP-3074-MC;

## Reason for recall

The stent-graft inside the delivery system was the incorrect size.

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The countries of   Chile, France, Germany, Italy, Japan, Poland, Spain, and Thailand.

## Key facts

- **Recall number:** Z-1383-2024
- **Recalling firm:** Bolton Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2024-02-22
- **Report date:** 2024-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunrise, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1383-2024

## Citation

> AI Analytics. FDA recall Z-1383-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1383-2024. Source: US FDA. Licensed CC0.

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