ModerateClass IICompleted

FDA Devices recall · Reported April 3, 2024

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-

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on April 3, 2024. Severity: Moderate. Recall number: Z-1383-2024.

Q: Where was the recalled product distributed?

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..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1383-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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

Recall #: Z-1383-2024
Affected scope: 21 devices
Initiated: February 22, 2024

Compiled from official public sources by the editorial team. · Updated August 2026

Verify with FDA Devices →

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Bolton Medical Inc. recalled RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IF… - a moderate-severity action.

RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IF… was recalled by Bolton Medical Inc. in April 3, 2024. Reason: The stent-graft inside the delivery system was the incorrect size.. Check the official notice for the remedy. Verify recall #Z-1383-2024 with the FDA Devices before acting.

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The recall

Bolton Medical Inc. issued this moderate-severity FDA Devices recall-The stent-graft inside the delivery system was the incorrect size..

Moderate
severity level: 21 units
affected scope: Class II
classification: April 3, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1383-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1383-2024) was formally reported on April 3, 2024, with the manufacturer initiating the action on February 22, 2024. It is classified under Moderate severity (Class II), with a current status of Completed. Bolton Medical Inc. is listed as the recalling firm, operating out of Sunrise, FL. Federal records list the affected scope as 21 devices.

The documented reason for this recall is: The stent-graft inside the delivery system was the incorrect size. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The countries of Chile, France, Germany, Italy, Japan, Poland, Spain, and Thailand.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

21 devices

Related Recalls

3 from same agency

Product description

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Completed
Recall number	Z-1383-2024
Date reported	April 3, 2024
Date initiated	February 22, 2024
Recalling firm	Bolton Medical Inc.
Firm location	Sunrise, FL
Affected scope	21 devices
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.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

21 devices units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1383-2024) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 3, 2024. Severity: Moderate. Recall number: Z-1383-2024.

Where was the recalled product distributed? ▼

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..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1383-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 3, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.