Emerge™ H7493918908300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729806547), received between Sep 10, 2018 and Jan 5, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. A 3.00MM X 8MM EMERGE BALLOON CATHETER WAS USED IN A PERCUTANEOUS CORONARY INTERVENTION; HOWEVER, DEFLATION ISSUE WAS NOTED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450062 ↗
• MalfunctionOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04OCT2018. THIS 3.00MM X 8MM EMERGE BALLOON CATHETER WAS RECEIVED WITH NO REPORTED ISSUES. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SEPARATED HYPOTUBE. DEVICE EVALUATED BY MANUFACTURER: THE 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 ALONG THE HYPOTUBE. THE HYPOTUBE IS SEPARATED 79.6CM FROM THE HUB. MICROSCOPIC EXAMINATION REVEALED THAT THE TIP IS DAMAGED AND THE BALLOON IS LOOSE. THERE IS BLOOD PRESENT IN THE HUB, INFLATION LUMEN, AND BALLOON. THE BROKEN SHAFT WAS CONNECTED TO A TUOHY ADAPTER AND STOPCOCK THEN INFLATED USING A BALLOON INFLATION DEVICE TO CHECK FOR POSSIBLE DAMAGES TO THE BALLOON. THE BALLOON WAS INFLATED TO RBP OF 14ATM AND COULD HOLD PRESSURE FOR 5 MINUTES BEFORE IT WAS DEFLATED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005690 ↗
• MalfunctionSep 25, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF THE DEVICE, THE PHYSICIAN TOOK THE BALLOON OUT OF THE LOOP IN THE HYPOTUBE. IT WAS NOTICED THAT THE SHAFT SEPARATED WHERE THE HYPOTUBE MEETS THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7906161 ↗
• MalfunctionSep 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A HEAVILY CALCIFIED VESSEL. A 3.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON MATERIAL WAS TORN IN THE PROCESS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7862427 ↗