Bolton Medical flags elevated endotoxins on TREO, RelayPro and RelayPlus delivery systems
A Dutch IGJ notice reports that Bolton Medical's internal review found about 1% of units may exceed the endotoxin specification, prompting a field safety notice.
The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer warning concerning Bolton Medical's TREO, RelayPro and RelayPlus devices. The company identified elevated endotoxins on the delivery systems of these products through an internal review.
According to the notice, current testing indicates that roughly 1% of units carry a risk of endotoxin levels above the specification. The text published by IGJ does not set out further detail on the testing, the affected batches or any clinical consequences.
The field safety notice (FSN) is dated 3 November 2026, and the IGJ page carries a date of 5 November 2026. The English-language PDF of the warning, 17 pages long, is titled with 6 November 2026. Terumo Europe N.V. is named as the authorised representative for Bolton Medical.
IGJ explains that manufacturers must monitor devices after they are placed on the market and improve them where necessary. When a risk to users arises, the manufacturer must act and inform both users and the inspectorate through a field safety notice. The page does not describe the specific corrective actions requested; these are presumably set out in the attached document.
What it means for your team
- Affected users and distributors should consult the full 17-page FSN for the scope of affected units and any instructions, as the IGJ summary gives no actions.
- Quality and complaint-handling teams should check inventory and any reports linked to TREO, RelayPro and RelayPlus delivery systems against the notice.
- Regulatory affairs teams at distributors should confirm receipt of the FSN and coordinate with Terumo Europe N.V. as authorised representative.
- Endotoxin specification exceedances are a product quality and patient safety matter, so vigilance teams may wish to review related incident reports.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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