Manufacturer field safety notice (removal) · FSN2026-003 · Bolton Medical / Terumo Aortic · Last updated

Are RelayPlus, RelayPro, or TREO stent graft systems recalled?

The manufacturer is conducting a voluntary recall (removal) of all unexpired units. Bolton Medical Inc., operating as Terumo Aortic, is removing all Relay®Plus Thoracic Stent Graft System, Relay®Pro Thoracic Stent Graft System, and TREO® Abdominal Stent-Graft System units that are still within expiry, because of potential endotoxins on the delivery system (FSN2026-003). The notice is listed by UK MHRA (published 10 November 2026) and posted in English by the Dutch IGJ. This page is not an FDA notice for that endotoxin issue. A separate FDA Class I recall covers a narrower RelayPro N4 subset for a different problem (proximal clasp / failure to release) — do not merge the two.

Last updated: · Primary: manufacturer letter FSN2026-003 (English PDF posted by IGJ) and the UK MHRA Field Safety Notices list published 10 November 2026 (list-level issued date 2 November 2026; IGJ FSN date 3 November 2026). A unit count and a US or global distribution list were not published — this page does not invent them. This is not a confirmed FDA or United States recall for the endotoxin issue, and it is not accurate to describe the listing as United Kingdom-only.

Framing
Manufacturer FSN (removal) FSN2026-003; listed by UK MHRA; posted by Dutch IGJ
Firm
Bolton Medical Inc., operating as Terumo Aortic
Devices
RelayPlus, RelayPro, and TREO — all units within expiry
Problem
Elevated endotoxins on the delivery systems; about 1% of units may exceed specification
Complaints (since 2023)
26 related to fever, infection, inflammation, and sepsis; 4 included death; manufacturer-stated rate 0.07%; causal link not confirmed and not ruled out
Already implanted
Notice does not require explant; routine observation and follow-up
MHRA reference
41342809 2026/011/001/601/005
Contact
[email protected]

Identify product ↓ · Why it matters ↓ · Already implanted ↓ · What to do ↓

Which systems are affected

Per the manufacturer letter, Bolton Medical Inc., operating as Terumo Aortic, is conducting a voluntary medical device recall (removal) of all RelayPlus, RelayPro, and TREO stent-graft systems within expiry due to potential endotoxins present on the delivery system. Refer to Appendix 1 of the official notice for the full material / EAN-GTIN list — this page does not paste the entire table.

Device (manufacturer letter)Scope on the notice
Relay®Plus Thoracic Stent Graft SystemAll such systems within expiry
Relay®Pro Thoracic Stent Graft SystemAll such systems within expiry
TREO® Abdominal Stent-Graft SystemAll such systems within expiry
  1. The MHRA list entry is titled Bolton Medical: TREO / RelayPro / RelayPlus 48060, Ref FSN2026-003, Model: ALL models, MHRA reference 41342809 2026/011/001/601/005.
  2. IGJ identifies the manufacturer as Bolton Medical, with authorized representative Terumo Europe N.V., and lists the FSN date as 3 November 2026.
  3. A unit count and a US or global distribution list were not published on the notice — left blank on purpose. This page does not invent them.

Reason for the field safety notice

Through an internal review, elevated endotoxins on the delivery systems has been identified. The notice states that current testing shows about 1% of the units have the risk of endotoxin levels above the specification.

Endotoxin is a pyrogen that can create reactions from fever to more serious and rarely potentially life-threatening outcomes, including sepsis, septic shock, organ failure, and death.

The manufacturer states that since 2023, 26 complaints have been received related to fever, infection, inflammation, and sepsis. Four of these complaints included the outcome of death. The notice describes this as a rate of 0.07%; it does not publish the denominator used for that rate, and this page does not invent one. As the etiology of an infection or inflammatory response can be related to circumstances unrelated to the procedure or device, the root cause of the complaints was not necessarily tied to this issue but cannot be ruled out at this time. Those figures are historical complaints summarized on the notice — not a confirmation of product causation for the deaths mentioned, not a fatality rate calculated from the 26 complaints, and not new deaths reported today.

This page is not medical advice. If symptoms appear, seek medical care and follow the treating clinician.

If a stent is already implanted

The notice does not require explant or removal of an already implanted stent. It recommends close observation for signs of inflammation during the initial hospitalization and provider follow-up at regular intervals as routinely performed after implant, especially in high-risk patients (significant comorbidities or who are immunocompromised).

The letter lists these signs to monitor:

  • Fever, chills, malaise
  • Nausea, vomiting, diarrhea
  • Hypotension (low blood pressure)
  • Respiratory distress
  • Coagulopathy (clotting abnormalities)
  • In severe cases: sepsis, multi-organ dysfunction

If such symptoms are identified, the notice says routine evaluation and assessment for other, more common causes, such as infection or post-implant syndrome, is recommended, and treatment should follow standard medical practice for the symptoms.

What consignees should do

The manufacturer letter’s customer actions are:

  1. Immediately discontinue use of the Relay Plus, Relay Pro, and Treo.
  2. Isolate affected inventory to prevent future use.
  3. If devices have been transferred to another facility, provide a copy of the notification and instruct them to follow these actions.
  4. Complete Appendix 2 with the number of units in your control to be returned to Terumo. The form is required even if you do not have product on hand.
  5. Contact a Terumo Representative to initiate the return.

Questions on this letter: [email protected] or the Terumo Aortic Representative. The firm says a thorough root-cause investigation is ongoing; one potential source has been identified at a supplier and a corrective action has already been implemented.

More: what to do with a recalled product · search FDA food/drug/device recalls

Date notes

  • IGJ lists the FSN date as 3 November 2026. The IGJ page and PDF are dated around 6 November 2026.
  • MHRA published the Field Safety Notices list on 10 November 2026, with a list-level issued date of 2 November 2026.
  • The MHRA page title refers to the window 2–6 November 2026; a line on that same page also says “October.” This page keeps that discrepancy and does not invent a single recall start date.

Not the FDA Class I RelayPro N4 clasp recall

This page is FSN2026-003 (endotoxin on the delivery system, covering all unexpired RelayPlus, RelayPro, and TREO systems). A separate FDA Class I recall concerns RelayPro N4 Non-Bare Stent Configuration 32 mm and above (proximal clasp / failure to release from the delivery system), not endotoxin, with a different complaint and death set. The firm update for that issue is FSN2026-002. Do not merge the counts or the remedies.

Official sources

A unit count, a US or global distribution list, and a confirmed FDA notice for this endotoxin issue are not published on the sources above — this page does not invent them.

Not affiliated with MHRA, IGJ, FDA, Bolton Medical Inc., or Terumo. This page is independent reporting of official notices, not medical advice.

FDA food and drug recall checker · Latest product recalls · Latest UK recalls

FAQ

Are RelayPlus, RelayPro, or TREO stent graft systems recalled?

Bolton Medical Inc., operating as Terumo Aortic, is conducting a voluntary medical device recall (removal) of all RelayPlus, RelayPro, and TREO stent-graft systems that are still within expiry, because of potential endotoxins on the delivery system (FSN2026-003). The notice is listed by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and published in English by the Dutch Health and Youth Care Inspectorate (IGJ). This page is not an FDA notice for that endotoxin issue.

Which devices and models are included?

The manufacturer letter covers the Relay®Plus Thoracic Stent Graft System, the Relay®Pro Thoracic Stent Graft System, and the TREO® Abdominal Stent-Graft System — all such systems within expiry. The MHRA list entry is titled “Bolton Medical: TREO / RelayPro / RelayPlus 48060,” reference FSN2026-003, model: ALL models, MHRA reference 41342809 2026/011/001/601/005. The full material / EAN-GTIN list is in Appendix 1 of the official field safety notice; this page does not reproduce the entire table. A unit count and a country-by-country distribution list are not published on the notice — this page does not invent them.

What is the problem and the health risk?

Through an internal review, the manufacturer identified elevated endotoxins on the delivery systems. The notice states that current testing shows about 1% of the units have the risk of endotoxin levels above the specification. Endotoxin is a pyrogen that can create reactions from fever to more serious and rarely potentially life-threatening outcomes, including sepsis, septic shock, organ failure, and death.

What do the 26 complaints and four deaths on the notice mean?

The manufacturer states that since 2023, 26 complaints have been received related to fever, infection, inflammation, and sepsis, and that four of these complaints included the outcome of death. The notice describes this as a rate of 0.07%; it does not publish the denominator used for that rate, and this page does not invent one. The notice also states that the etiology of an infection or inflammatory response can be related to circumstances unrelated to the procedure or device, so the root cause of the complaints was not necessarily tied to this issue but cannot be ruled out at this time. This page does not treat those historical complaints as a confirmed causal finding, as a fatality rate calculated from the 26 complaints, or as new deaths reported today.

What should hospitals and other consignees do?

The letter’s customer actions are: 1) Immediately discontinue use of the Relay Plus, Relay Pro, and Treo. 2) Isolate affected inventory to prevent future use. 3) If devices were transferred to another facility, provide a copy of the notification and instruct them to follow these actions. 4) Complete Appendix 2 with the number of units in your control to be returned (the form is required even if you do not have product on hand). 5) Contact a Terumo Representative to initiate the return. Questions: [email protected] or the Terumo Aortic Representative. The firm says a root-cause investigation is ongoing; one potential supplier source has been identified and a corrective action has already been implemented.

I already have an implanted RelayPlus, RelayPro, or TREO stent. Does the notice require it to be removed?

No. The notice does not require explant or removal of an already implanted stent. It recommends close observation for signs of inflammation during the initial hospitalization and provider follow-up at regular intervals as routinely performed after implant, especially in high-risk patients (those with significant comorbidities or who are immunocompromised). Symptoms listed on the notice include fever, chills, or malaise; nausea, vomiting, or diarrhea; hypotension; respiratory distress; coagulopathy; and, in severe cases, sepsis or multi-organ dysfunction. If symptoms appear, seek medical care. This page is not medical advice.

Is this the same as the FDA Class I RelayPro N4 recall?

No. This page is FSN2026-003 (endotoxin on the delivery system, covering all unexpired RelayPlus, RelayPro, and TREO systems). A separate FDA Class I recall concerns RelayPro N4 Non-Bare Stent Configuration 32 mm and above (proximal clasp / failure to release from the delivery system), not endotoxin, with a different complaint and death set. The firm update for that issue is FSN2026-002. Do not merge the counts or the remedies.

Is this an FDA or United States recall? Where does it apply?

This is a manufacturer field safety notice (removal) listed by UK MHRA and also posted in English by the Dutch IGJ. The letter addresses consignees of all within-expiry units. It does not publish a unit count or a US or global distribution list, and this page does not invent either. This page does not treat FSN2026-003 as a confirmed FDA or United States recall for the endotoxin issue, and it does not infer a worldwide expansion or a US synchronization from the manufacturer’s contact details. Because IGJ also published the English notice, it is not accurate to describe the listing as United Kingdom-only.

When was this notice dated and published?

Keep the dates distinct; this page does not invent a single recall start date. The IGJ listing gives the FSN date as 3 November 2026, and the IGJ page and PDF are dated around 6 November 2026. MHRA published its Field Safety Notices list on 10 November 2026, with an issued date of 2 November 2026 at list level. The MHRA page title refers to the window 2–6 November 2026; a line on that same page also says “October.” This page keeps that discrepancy.

Update log
  • November 10, 2026 — Shipped curated landing from manufacturer FSN2026-003 (English PDF posted by Dutch IGJ) and the UK MHRA Field Safety Notices list published 10 November 2026. Kept separate from the FDA Class I RelayPro N4 clasp recall (FSN2026-002). No invented unit count, US/global distribution, or FDA endotoxin recall. No catch-up daily; fold into next Sunday weekly high-risk section.