CLASS II Device recall · Reported 3 Apr 2024 · FDA Enforcement Report
Relay PRO Thoracic Stent-Graft System recalled by Bolton Medical
Bolton Medical is recalling Relay PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, distributed nationwide in the US. The recall was initiated on 22 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1383-2024
- FDA event ID
- 93873
- Recalling firm
- Bolton Medical, Sunrise, FL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 22 Feb 2024
- FDA classified
- 27 Mar 2024
- Reported
- 3 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 22 Feb 2024 | Recall initiated by company | |
| 27 Mar 2024 | Classified by FDA | +34 days |
| 3 Apr 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The stent-graft inside the delivery system was the incorrect size.
Product as listed by the FDA
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;
Where it was distributed
Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The countries of Chile, France, Germany, Italy, Japan, Poland, Spain, and Thailand.
Questions about this recall
Why was it recalled?
The stent-graft inside the delivery system was the incorrect size.
Which lots are affected?
(a) Part number 28-M4-34-100-34U - Lot #2112080111 and #2112080158, UDI 843576149656; (b) Part number 28-M4-30-095-30U - Lot #2112080147 and #2112080148, UDI 843576149632; (c) Part number 28-M4-46-155-46U - Lot #2112100328, UDI 843576149847; (d) Part number 28-M4-32-155-32S - Lot #B211209120, UDI 843576100183; (e) Part number 28-M4-36-250-32S - Lot #B211203197, UDI 843576100763; (f) Part number 28-M4-38-145-34S - Lot #B211206395, UDI 843576100572; (g) Part number 28-M4-38-190-38S - Lot #B211202319, UDI 843576100343; (h) Part number 28-M4-44-105-44S - Lot #B211209068, UDI 843576100114; (i) Part number 28-N4-22-099-22S - Lot #B211208120, UDI 843576100824; (j) Part number 28-N4-22-159-22S - Lot #B211208162, UDI 843576100954; (k) Part number 28-N4-24-099-24S - Lot #B211130071 and #B211207227, UDI 843576100831; (l) Part number 28-N4-28-204-24S - Lot #B211209065, UDI 843576101449; (m) Part number 28-N4-30-164-30U - Lot #2112100333, UDI 843576150584; (n) Part number 28-N4-32-164-28S - Lot #B211207181, UDI 843576101364; (o) Part number 28-N4-34-154-34U - Lot #2112090117, UDI 843576150607; (p) Part number 28-N4-34-209-30S - Lot #B211209073, UDI 843576101470; (q) Part number 28-CMP-3062-NC - Lot #2112100385, no UDI; and (r) Part number 28-CMP-3074-MC - Lot #2112100383, no UDI;
Where was it sold?
Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The countries of Chile, France, Germany, Italy, Japan, Poland, Spain, and Thailand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bolton Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | RelayPro Thoracic Stent-Graft System recalled by Bolton Medical | Bolton Medical | Other | PR |
| Device | CLASS II | The Treo Abdominal Stent-graft System recalled by Bolton Medical | Bolton Medical | Other | Nationwide |
| Device | CLASS II | Relay Pro, Thoracic Stent-graft System recalled by Bolton Medical | Bolton Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Relay Pro, Thoracic Stent-graft System recalled by Bolton Medical | Bolton Medical | Packaging Defects | Nationwide |
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