Merit Medical warns of guidewire resistance with Philips Bridge occlusion balloon catheters in prep kit
Merit Medical has issued a field safety notice, published by the Dutch inspectorate, over resistance when Philips Bridge balloons are advanced over the guidewire in the Bridge Prep Kit.
The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer field safety notice (FSN) from Merit Medical Systems concerning the Bridge Prep Kit, which Merit makes and Philips distributes. The FSN is dated 22 October 2026, and the IGJ listing carries the date 28 October 2026.
Merit says it recently became aware of a possible device interaction problem. In some cases, the Philips Bridge Occlusion Balloon catheter, which Philips manufactures, may meet resistance when advanced over the 0.035-inch InQwire Amplatz guidewire supplied in the kit (model IQA502P).
The notice sets out the health risk. Where a bleed must be brought under control quickly, being unable to advance the Philips balloon over the Merit guidewire to the intended site could delay haemostasis.
The IGJ lists Merit Medical Systems as manufacturer and Merit Medical Ireland Limited as authorised representative. The product is named as the Philips Bridge Balloon Prep Kit. The inspectorate's page links to a four-page PDF of the notice. The text available here does not describe affected lots, corrective actions or the instructions given to users, so these should be checked in the full document.
The IGJ explains that manufacturers must monitor devices after they reach the market and act when users face a risk, informing users and the inspectorate through a field safety notice.
What it means for your team
- Quality and regulatory teams at hospitals and distributors should read the full FSN PDF for affected lots, user instructions and any required response.
- Vigilance staff may wish to check for any reports of difficulty advancing Bridge balloons over the IQA502P guidewire.
- Manufacturers combining components from different companies in a kit should note that this notice concerns an interaction between a Merit guidewire and a Philips catheter.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
Market accessCompany releaseMedicare begins paying for Lucid's EsoGuard as PAVmed's Veris nears FDA 510(k) filing
Market accessOfficialDenmark updates Voltabak eye drop supply notice, with shortage expected to run to mid-May 2027
Market accessOfficialMethergin 0.2 mg/ml injection withdrawn from Danish market, DKMA reports
Market accessOfficialDenmark updates import window for estradiol 25 microgram patches in supply failure
Market accessOfficialDKMA updates Vivelle Dot 37.5 supply notice: shortage expected to last until end of December
Market accessOfficial