PharmacovigilanceOfficial

Merit Medical recalls Surfacer Inside-Out access catheter system sheath over detaching radiopaque tip

🇨🇦 Health Canada · Tue 10 Nov 2026

Health Canada lists a Type I recall of the Surfacer system's Workstation Sheath and Dilator after four complaints, two involving adverse events.

Merit Medical Systems is voluntarily recalling the Workstation Sheath and Dilator supplied with the Surfacer Inside-Out Access Catheter System, Health Canada has announced. The problem is that the radiopaque tip of the sheath can detach.

The regulator classes the action as Type I and gives a recall date of 3 November 2026. Its notice, reference RA-82937, was published on 10 November 2026 under the cardiovascular medical devices category.

Merit has received four product complaints to date. Two of them were adverse events. The notice does not describe the nature of those events or the patient outcomes.

Five lots of model or catalogue number 600200/C are affected: 3434780000, 3414970000, 3409530000, 3416110000 and 3404290000. Health Canada's advice is that healthcare users should contact the manufacturer if they need more information. Merit is based in South Jordan, Utah.

For context, a Type I recall in Canada is the category used where use of a product could cause serious adverse health consequences or death.

What it means for your team

  • Healthcare facilities in Canada should check inventory against the five listed lots of model 600200/C and contact Merit for further instructions.
  • Quality and complaint-handling teams should note that the failure mode is component detachment, a performance issue, and that two of the four complaints were adverse events.
  • Regulatory teams with the same device on other markets should check whether equivalent field actions have been or will be notified, since the Health Canada notice covers only Canada and gives no wider scope.

Official source: Health Canada ↗

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

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