Emerge™ H7493918908150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729806493), received between Jan 5, 2017 and Feb 11, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM X 8MM AND A 2.50MM X 15MM EMERGE BALLOON CATHETERS WERE SELECTED TO PERFORM KISSING BALLOON TECHNIQUE. HOWEVER, BOTH DEVICES HAD DIFFICULTY ADVANCING THROUGH THE GUIDE CATHETER AND THE SHAFT BROKE ON BOTH BALLOONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9695686 ↗
• MalfunctionJun 25, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.50MM X 8MM EMERGE BALLOON CATHETER WAS USED FOR DILATATION BUT THE DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733020 ↗
• MalfunctionDec 18, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 6FR JR4 NON-BSC GUIDE CATHETER WAS USED AND A 180CM NON-BSC GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. A 1.50MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, IT WAS NOTED THAT THE SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8176917 ↗
• MalfunctionOct 24, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-OCT-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 100% STENOSED, 38MMX2.75MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MID AND DISTAL RIGHT CIRCUMFLEX ARTERY. A 1.50MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.   DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN EMERGE BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED MULTIPLE KINKS ON THE HYPOTUBE. THE HYPOTUBE IS SEPARATED 33.9CM FROM THE HUB. MICROSCOPIC EXAMINATION REVEALED THAT THE TIP IS DAMAGED. THERE IS BLOOD PRESENT IN THE GUIDEWIRE LUMEN AND THE BALLOON IS LOOSE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES CONTRIBUTING TO THE REPORTED CROSSING DIFFICULTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001924 ↗
• MalfunctionSep 25, 2018Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT DETACHMENT OCCURED. DURING PREPARATION, WHILE THE PHYSICIAN PLACED THE 1.5 X 8MM EMERGE BALLOON CATHETER ON THE GUIDEWIRE, IT WAS NOTED THAT THE DISTAL TIP OF THE CATHETER WAS COMPLETELY DETACHED FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7908378 ↗
• MalfunctionJan 5, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 1.50MM X 8MM EMERGE¿ CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE INSIDE THE TUOHY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6226664 ↗