Merit Medical pulls five lots of Surfacer sheath in Canada after tip-detachment complaints

Merit Medical Systems has begun a voluntary recall in Canada of a component supplied with its Surfacer Inside-Out Access Catheter System, according to a notice from Health Canada. The component is the Workstation Sheath and Dilator, and the stated defect is that the sheath's radiopaque tip can come off.

The regulator labelled the action Type I and recorded a recall date of 3 November 2026. It published the entry, reference RA-82937, on 10 November under cardiovascular devices. Five lots of catalogue number 600200/C are covered: 3434780000, 3414970000, 3409530000, 3416110000 and 3404290000.

Merit, which is based in South Jordan, Utah, has logged four complaints so far, two of them classed as adverse events. The notice does not say what happened in those cases or how patients fared. It also gives no count of units affected, no word on replacement stock and no estimate of any financial impact, so the commercial consequences for Merit cannot be judged from the filing.

By way of context, Type I is the Canadian category for situations where using a product could lead to serious harm or death. The notice directs healthcare users to contact the manufacturer for further information. It covers Canada only and says nothing about whether the same lots, or similar actions, apply in other markets.