Merci 9F 90074Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00815742000740), received between Mar 4, 2021 and Jun 2, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A PATIENT WITH A RIGHT INTERNAL CAROTID ARTERY THROMBOSIS, THE PHYSICIAN USED A BALLOON GUIDE CATHETER TO ESTABLISH ACCESS AND BLOCK ANTEGRADE FLOOD FLOW IN THE INTERNAL CAROTID ARTERY. THE SUBJECT BALLOON GUIDE CATHETER WAS SUCCESSFULLY DELIVERED TO THE ICA AND POSITIONED. THE PHYSICIAN BEGAN TO INFLATE THE BALLOON GUIDE CATHETER. WHEN 0.6ML OF CONTRAST AGENT WAS INJECTED, CONTRAST AGENT LEAKAGE WAS OBSERVED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360906 ↗
• MalfunctionAug 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING MECHANICAL THROMBECTOMY, INFLATION OF THE SUBJECT BALLOON WITH IMMEDIATE LEAKAGE OF PRODUCT OBSERVED ON FLUOROSCOPY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894575 ↗
• MalfunctionMay 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SUBJECT BALLOON CATHETER WAS FOUND TO BE LEAKING DURING THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19252030 ↗
• MalfunctionMay 3, 2024Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT BALLOON CATHETER RUPTURED INSIDE THE PATIENT ANATOMY. THE CONTRAST LEAKED WHEN INFLATING THE BALLOON. THE SUBJECT BALLOON CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238568 ↗
• MalfunctionJan 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY (ICA) THROMBECTOMY CASE, A BALLOON GUIDE CATHETER WAS USED TO BUILD ACCESS ALONG WITH AN ASPIRATION CATHETER AND IT COULD NOT PASS THROUGH THE TORTUOUS VESSEL, SO A DIFFERENT MODEL OF ASPIRATION CATHETER WAS USED. CONTRAST AGENT WAS FOUND LEAKING WHEN DILATING THE TIP OF THE SUBJECT BALLOON CATHETER AND WHEN RETRACTED IT WAS FOUND DAMAGED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595554 ↗
• MalfunctionNov 3, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING RIGHT INTERNAL CAROTID ARTERY (ICA) THROMBUS PROCEDURE, THE OPERATOR PLACED THE SUBJECT BALLOON GUIDE CATHETER (BGC) TO BUILD ACCESS IN ICA AND THEN PLACED ANOTHER CATHETER. NEXT, THE OPERATOR DELIVERED TO THE LOCATION A STENT AND INFLATED THE SUBJECT BALLOON. HOWEVER, THE CONTRAST WAS FOUND TO BE LEAKING AND THE SUBJECT BALLOON WAS FOUND TO BE BROKEN. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18068158 ↗
• MalfunctionAug 22, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED DURING A RIGHT INTERNAL CAROTID ARTERY (ICA) THROMBUS CASE WHEN THE BALLOON (SUBJECT DEVICE) WAS DELIVERED TO THE TREATMENT SITE AND INFLATED, CONTAST AGENT WAS FOUND LEAKING FROM IT. THE BALLON WAS REMOVED AND A HOLE WAS FOUND ON THE DEVICE. IT WAS REPALCED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266125 ↗
• MalfunctionApr 20, 2021Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT DURING A MIDDLE CEREBRAL ARTERY ACUTE THROMBECTOMY CASE, THE CONTRAST AGENT USED TO DILATE THE BALLOON (SUBJECT DEVICE) LEAKED IN THE PATIENT. THE SUBJECT BALLOON WAS REMOVED FROM THE PATIENT ANATOMY AND DILATED. IT WAS FOUND TO HAVE RUPTURED. THE PHYSICIAN REPLACED THE SUBJECT DEVICE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698196 ↗
• MalfunctionMar 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLOON CATHETER (SUBJECT DEVICE) WAS PREPARED AS PER THE DIRECTION FOR USE OF THE DEVICE FOR STROKE TREATMENT. WHEN THE SUBJECT BALLOON WAS INSIDE THE PATIENT'S ANATOMY, IT WAS FOUND THAT CONTRAST WAS LEAKING FROM IT. 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 11418485 ↗

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