MAMBA™ Flex H7493928715000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729940326), received between May 11, 2022 and Jun 20, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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 18, 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.

• MalfunctionJun 20, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DIFFICULTY TO REMOVE A MICROCATHETER OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN A MILDLY TO MODERATELY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED RIGHT CORONARY ARTERY. THIS 150CM MAMBA FLEX MICROCATHETER WAS SELECTED FOR USE. UPON ADVANCEMENT OF MAMBA TOWARDS OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE TO THE MID AND PROXIMAL CHRONIC TOTAL OCCLUSION (CTO) LESION, THE GUIDEWIRE KNUCKLED BACK ONTO ITSELF, AND THE PHYSICIAN WAS ABLE TO STRAIGHTEN GUIDEWIRE. THE PHYSICIAN TRIED TO ADVANCE THE GUIDEWIRE AND MAMBA TOGETHER, BUT THE GUIDEWIRE BECAME FROZEN IN THE MAMBA CATHETER AND WAS UNABLE TO ADVANCE AND REMOVED FROM MAMBA CATHETER. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE GUIDEWIRE BUT WERE UNSUCCESSFUL. THEN, BOTH THE GUIDEWIRE AND MICROCATHETER HAD TO BE PULLED AND REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS CANCELED AND THERE WERE NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161475 ↗
• InjuryMay 11, 2022Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DIFFICULTY TO REMOVE A MICROCATHETER OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF A CHRONIC TOTAL OCCLUDED ARTERY WAS PERFORMED ON A PATIENT WITH CORONARY ARTERY DISEASE (CAD). THE TARGET LESION WAS LOCATED IN THE 100% STENOSED SEVERELY CALCIFIED BIFURCATED LEFT MAIN (LM) ARTERY AND BIFURCATED OBTUSE MARGIN (OM) ARTERY. A 150 CM MAMBA FLEX MICROCATHETER WAS ADVANCED TO THE CALCIFIED LESION, DISTAL TO THE CHRONIC TOTAL OCCLUSION (CTO), BUT DIFFICULTIES REMOVING THE DEVICE OCCURRED. THE DEVICE WAS UNABLE TO PULL BACK. ANOTHER WIRE AND BALLOON WERE INSERTED BESIDE THE MICROCATHETER, AND THE BALLOON WAS INFLATED SEVERAL TIMES. THE MAMBA THEN BECAME UNSTUCK, AND WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH OTHER STENTS, WHICH WERE POST DILATED. THERE WERE NO FURTHER ISSUES, AND NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14360667 ↗