Merci 9F 90077Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815742000771), received between Jul 21, 2018 and Jul 24, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K112404); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON BURST. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713219 ↗
• MalfunctionJul 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON BURST. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7708968 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112404. One submission often covers many models, so check the product and lot details in each record.

• Z-0065-2020 · Nov 13, 2018 · Terminated
  Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771