Merci 8F 90073Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00815742000733), received between May 9, 2018 and Nov 28, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY (ICA) OCCLUSION CASE WHEN THE BALLOON (SUBJECT DEVICE) WAS DELIVERED TO THE TREATMENT SITE AND INFLATED, CONTRAST AGENT WAS FOUND LEAKING FROM IT. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868757 ↗
• MalfunctionOct 10, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE BALLOON (SUBJECT DEVICE) WAS INFLATED IN THE ICA (INTERNAL CAROTID ARTERY) BUT ONCE THE CLOT RETRIEVAL WAS COMPLETED THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO DEFLATE AND BURST THE BALLOON BEFORE PULLING THE SUBJECT BALLOON GUIDE CATHETER OUT OF THE PATIENT WHILE THE BALLOON WAS INFLATED RESULTING IN SURGICAL DELAY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15568616 ↗
• MalfunctionDec 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLOON (SUBJECT DEVICE) COULD NOT BE DILATED DURING THE PROCEDURE. THE SUBJECT BALLOON WAS FOUND LEAKING DURING THE PROCEDURE WHEN REMOVED FROM THE PATIENT'S ANATOMY. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11073970 ↗
• MalfunctionJul 29, 2020Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE INFLATING THE BALLOON (SUBJECT DEVICE), THE CONTRAST MEDIUM WAS LEAKING INTO THE VESSEL. THE SUBJECT BALLOON HAD DIFFICULTY DEFLATING INSIDE THE PATIENT¿S ANATOMY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10341250 ↗
• MalfunctionApr 3, 2020Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT BALLOON CATHETER WAS EXPERIENCING DIFFICULTY INFLATING AND WAS NOTED TO BE LEAKING. UPON REMOVAL OF THE SUBJECT DEVICE, PHYSICIAN IDENTIFIED THAT THE BALLOON HAD RUPTURED. THE PHYSICIAN REPLACED THE DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9925234 ↗
• MalfunctionJul 19, 2018Deflation Problem; Deflation Problem

  MEDWATCH REPORT (MW5077097) WAS RECEIVED FROM THE FDA ON JUNE 21, 2018. IT WAS REPORTED THAT AFTER THE THROMBECTOMY PROCEDURE, THE BALLOON CATHETER COULD NOT BE DEFLATED. THE BALLOON CATHETER EVENTUALLY WAS DEFLATED ENOUGH TO BE REMOVED FROM THE PATIENT¿S ANATOMY AND THE PROCEDURE WAS COMPLETED. NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7701816 ↗
• MalfunctionMay 9, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THE BALLOON FAILED TO INFLATE DURING PREPARATION AND A LEAK WAS NOTED. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7501441 ↗

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