MAMBA™ Flex H7493928713540Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729940289), received between Nov 2, 2020 and Sep 11, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 5, 2021Terminated

   The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

   Z-1429-2021 · Root cause: Labeling False and Misleading · Recall details · FDA record ↗

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.

• MalfunctionSep 11, 2025Difficult to Remove; Difficult to Remove

  IT REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT WITH STABLE CORONARY ARTERY DISEASE (CAD) UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TARGET LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) LOCATED IN THE CIRCUMFLEX ARTERY (CX), WHICH WAS MODERATELY TORTUOUS AND MILDLY CALCIFIED. A 135CM MAMBA FLEX MICROCATHETER WAS SELECTED FOR USE. A NON-BSC GUIDEWIRE WAS USED TO DELIVER THE MAMBA, THEN EXCHANGED FOR ANOTHER NON-BSC WIRE THAT SUCCESSFULLY CROSSED THE LESION. THE MAMBA WAS ADVANCED INTO THE DISTAL CX, AFTER WHICH THE SECOND WIRE WAS REMOVED, AND THE ORIGINAL GUIDEWIRE REINTRODUCED. DURING SUBSEQUENT REMOVAL OF THE MAMBA CATHETER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO RETRACT THE NON-BSC GUIDEWIRE. THE NON-BSC GUIDEWIRE BECAME FROZEN IN THE MAMBA CATHETER. AFTER CONSIDERABLE EFFORT, THE WIRE WAS SUCCESSFULLY REMOVED. DESPITE INCREASING RESISTANCE DURING MAMBA CATHETER REMOVAL, THE NON-BSC GUIDEWIRE WAS WIPED DOWN MULTIPLE TIMES IN AN EFFORT TO FACILITATE RETRACTION. FORTUNATELY, THE MAMBA WAS SUCCESSFULLY REMOVED WITHOUT COMPLICATION AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH OTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027422 ↗
• MalfunctionMar 6, 2024Difficult to Flush; Difficult to Remove; Difficult to Flush; Difficult to Remove

  IT REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE 70% STENOSED TARGET LESION WAS NONE TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). A 135 CM MAMBA FLEX WAS USED AS AN EXCHANGE DEVICE DURING A ROTABLATION PROCEDURE. THE MAMBA WAS FLUSHED, AND THE NON-BOSTON SCIENTIFIC (BSC) WIRE WAS INSERTED INTO THE CATHETER. THE MAMBA AND NON-BSC WIRE DEVICES PLACED INTO THE GUIDE CATHETER AT THE SAME TIME AND ADVANCED TO THE LESION WITH THE NON-BS WIRE LEADING ACROSS THE CALCIFIED LESION. THEN, THE NON-BSC WIRE WAS REMOVED, AND THE ROTOWIRE DRIVE WAS ADVANCED IN LESION. ONCE THE ROTOWIRE DRIVE WAS AT DISTAL TO THE LESION, THE MAMBA WAS REMOVED. THE ROTABLATION SUCCESSFULLY COMPLETED AND THE ROTAPRO WAS REMOVED OVER THE ROTAWIRE. THEN, THE MAMBA ADVANCED INTO THE DISTAL LAD OVER THE ROTAWIRE. UPON REMOVAL, THE ROTAWIRE WAS DIFFICULT TO REMOVE FROM THE MAMBA. THE PHYSICIAN REMOVED BOTH THE MAMBA CATHETER AND ROTAWIRE TOGETHER. THEN, THE ROTAWIRE REMOVED FROM THE MAMBA OUTSIDE THE PATIENT, AND TRIED TO FLUSH THE MAMBA BUT COULD NOT FLUSH IT. THE MAMBA CATHETER WAS ABLE TO FLUSH IT WITH A NON-BOSTON SCIENTIFIC SYRINGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852286 ↗
• MalfunctionAug 23, 2022Difficult to Flush; Physical Resistance/Sticking; Difficult to Flush; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022 IT WAS REPORTED THAT A GUIDEWIRE COULD NOT ADVANCE THROUGH THE DEVICE. A MAMBA INFUSION CATHETER WAS SELECTED FOR USE. DURING PREPARATION A GUIDEWIRE FAILED TO LOAD THROUGH THE MAMBA. THE MAMBA WAS REPLACED WITH ANOTHER MAMBA AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED FOREIGN MATERIAL WITHIN THE MAMBA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279041 ↗
• MalfunctionMar 20, 2022Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking; Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking

  IT REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE TARGET LESION WAS LOCATED IN THE 99% STENOSED SEVERELY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THIS 135CM MAMBA FLEX MICROCATHETER ALONG WITH A ROTAWIRE GUIDEWIRE WERE SELECTED. DURING THE PROCEDURE THE MAMBA MICROCATHETER BECAME STICKY AND WAS VERY DIFFICULT TO REMOVE FROM THE ROTAWIRE. THEY ATTEMPTED TO FLUSH THE LUMEN WHICH WAS ALSO DIFFICULT, THEY REMOVE THE DEVICE FROM THE PATIENT BY FIRMLY PULLING THE MAMBA OFF OF THE ROTAWIRE. DURING THE REMOVAL THE ROTAWIRE GUIDEWIRE BECAME SEVERELY MANGLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13830516 ↗
• MalfunctionMar 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A SEPARATION HAD OCCURRED. WHILE A PROCEDURE WAS IN PROGRESS, THE TIP OF THE 135CM MAMBA FLEX CATHETER SEPARATED FROM THE REST OF THE DEVICE. ALL COMPONENTS OF THE DEVICE REMAINED ON THE WIRE, AND THE PHYSICIAN WAS ABLE TO REMOVE EVERYTHING FROM THE PATIENT ANATOMY. IT WAS NOTED THAT THE VESSEL WAS SEVERELY CALCIFIED AND THOUGHT TO HAVE CAUSED THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11419052 ↗
• MalfunctionFeb 3, 2021Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THE CATHETER WAS DIFFICULT TO REMOVE AND FROZE ON THE GUIDEWIRE. AN ATHERECTOMY PROCEDURE WAS BEING PERFORMED ON A 90% STENOSED, SEVERELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. A MAMBA FLEX MICROCATHETER WAS BEING ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE AND COULD NOT BE ADVANCED ANY FURTHER OR BE REMOVED. IT BECAME STUCK ON THE GUIDEWIRE AND BOTH THE GUIDEWIRE AND MICROCATHETER HAD TO BE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272179 ↗
• MalfunctionNov 2, 2020Device Contamination with Chemical or Other Material; Physical Resistance/Sticking; Device Contamination with Chemical or Other Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED TO TREAT A BLOCKAGE IN THE OSTIAL RIGHT CORONARY ARTERY. A ROTA WIRE WAS BEING USED AND WOULD NOT ADVANCE THROUGH THE MAMBA FLEX MICROCATHETER. THE CATHETER WAS REMOVED AND FLUSHED AND A HAIR-LIKE SUBSTANCE CAME OUT. THE MAMBA DEVICE WAS NOT REINSERTED IN THE BODY. THE ROTA WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10771583 ↗