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MHRA publishes weekly Field Safety Notices list covering about two dozen device manufacturers

🇬🇧 MHRA alerts · Tue 10 Nov 2026

The list names Abiomed, Dexcom, Medtronic, Siemens and others; its title and description give different months, so teams should check the dates at source.

The Medicines and Healthcare products Regulatory Agency (MHRA) published its latest list of Field Safety Notices (FSNs) on 10 November 2026. The page title refers to notices from 2 to 6 November 2026, but the description line says 2 to 6 October 2026. The page itself gives an issue date of 2 November 2026, and many entries carry November dates, but the discrepancy should be confirmed with the MHRA.

Entries include Abiomed's Automated Impella Controller, Aerogen's benchtop nebulizer, Bolton Medical's TREO, RelayPro and RelayPlus devices, Datascope's Cardiosave intra-aortic balloon pumps and Dexcom's G7 iOS CGM app. The list also names Hologic's 3Dimensions and Selenia Dimensions mammography systems, Maquet's Rotaflow and Getinge Poladus 150 sterilizer, Philips' Lumify ultrasound system and Intuitive Surgical's SP Monopolar Curved Scissors Tip Cover.

Two Medtronic products appear: Vanta with AdaptiveStim Technology (model 977006) and the MyPTM App (model A820). Diagnostics and laboratory products are also listed, among them INOVA's Aptiva CTD Essential Reagent, the Myogenes Clozapine Test, Remel's Streptex latex agglutination test and several Siemens Atellica and Dimension products. The source text ends partway through an entry for Saluda Medical's Evoke Closed Loop Stimulator, so the list may be incomplete here.

The extract gives product names, models, MHRA reference numbers and manufacturer notice dates, but not the nature of each problem or the action requested. The MHRA says the notices are published for information only. It states that anyone who receives an FSN from a manufacturer must always act on it, and that questions about a specific notice should go to the manufacturer. As general context, an FSN is the communication a manufacturer sends to users about a field safety corrective action.

What it means for your team

  • Confirm the coverage period (October or November 2026) against the MHRA page before logging the list in your surveillance records.
  • Check the list against devices you make, distribute or use, then read the manufacturer's own FSN, because the MHRA entry does not describe the issue or the required action.
  • Act on any FSN you have received directly from a manufacturer; the MHRA list does not replace that notice.
  • Contact the relevant manufacturer with questions about a particular notice, as the MHRA directs.

Official source: MHRA alerts ↗

Article written by VigiEye from the official source (MHRA alerts). AI-assisted; check the source before acting.

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