MHRA's latest device safety notice list names Medtronic, Dexcom, Siemens, with date mismatch
The UK regulator's weekly roundup spans about two dozen manufacturers, from cardiac pumps to lab reagents, but gives no detail on faults or fixes, and its dates conflict.
The UK Medicines and Healthcare products Regulatory Agency published its newest weekly roundup of manufacturer field safety notices on 10 November 2026. It covers products from roughly two dozen device and diagnostics companies, among them Abiomed, Dexcom, Medtronic, Hologic, Philips, Intuitive Surgical and Siemens. The extract carries no information on sales exposure, recalls by volume or financial impact for any of them.
The page is inconsistent on timing. Its title places the notices in the week of 2 to 6 November 2026, while the description line says 2 to 6 October 2026. The page's own issue date is 2 November 2026, and many entries are dated in November, which points to the later period. Even so, the discrepancy remains unresolved and needs confirming with the MHRA.
Listed products include Abiomed's Automated Impella Controller, Datascope's Cardiosave balloon pumps, Dexcom's G7 iOS app, Hologic's 3Dimensions and Selenia Dimensions mammography systems, Philips' Lumify ultrasound and Maquet's Rotaflow. Medtronic has two entries: Vanta with AdaptiveStim Technology (model 977006) and the MyPTM App (model A820). Diagnostics entries span INOVA, Myogenes, Remel and several Siemens Atellica and Dimension products. The source text stops partway through an entry for Saluda Medical's Evoke Closed Loop Stimulator, so the list may be incomplete.
The entries give product names, models, MHRA reference numbers and manufacturer notice dates, but not the nature of each problem or the action requested. The agency says the list is for information only. Anyone who receives a notice directly from a manufacturer must act on it, and questions about a specific notice go to that manufacturer. By way of context, a field safety notice is the communication a manufacturer sends to users about a corrective action in the field.
Why it matters
- The list gives no data on units affected, costs or sales impact, so any commercial consequence for the named companies cannot be gauged from it.
- The names span implantable, hospital-capital, digital-health and laboratory categories, showing how broadly field actions reach across the UK device and diagnostics market.
- The conflicting October and November dates mean the coverage period should be verified at the MHRA source before the list is used in records.
- Detail on each issue sits with the manufacturers' own notices, not the regulator's roundup.
Official record: MHRA alerts ↗
Written by CompePharma's editorial system from the official record. AI-assisted; check the source before acting. Not investment advice.