Emerge™ H7493918920200Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729806301), received between Jan 11, 2017 and Jan 7, 2026 — classified as 1 death, 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.00MM X 20MM EMERGE? AND 2.00MM X 30MM EMERGE? BALLOON CATHETER WERE ADVANCED FOR USED. HOWEVER, DURING THE PROCEDURE, A DISTAL DISSECTION WAS OBSERVED. A STENT WAS PLACED AND THE EVENT RESOLVED WITHOUT SEQUELAE.

  Patient problems: Vascular Dissection

  MAUDE report 23999650 ↗
• MalfunctionApr 15, 2025Break; Inflation Problem; Adverse Event Without Identified Device or Use Problem; Break; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE DEVICE WAS DELIVERED TO THE TARGET SITE BUT FAILED TO INFLATE. UPON WITHDRAWAL, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21841062 ↗
• InjuryNov 15, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT IN-STENT RESTENOSIS AND DEFLATION ISSUES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING POST-INFLATION AT NOMINAL PRESSURE WITH A 50-50 SALINE CONTRAST, THE BALLOON WOULD NOT DEFLATE AND AN IN-STENT RESTENOSIS THROMBUS OCCURRED. THE DEVICE WAS REMOVED FROM THE PATIENT IN LESS THAN TWO MINUTES, INFLATED STATE AND INTACT. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: Restenosis

  MAUDE report 20695962 ↗
• MalfunctionJun 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CARDIAC CORONARY ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483678 ↗
• MalfunctionJun 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN. THE 28X3.0MM, 90% STENOSED, DE NOVO TARGET LESION CONTAINED A <=45 DEGREES BEND AND WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION IN THE AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING INITIAL INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213074 ↗
• MalfunctionJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED, 3.80MM X 20MM, CONCENTRIC, DE NOVO TARGET LESION WITH A BEND OF <= 45 DEGREES WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED THREE TIMES AT 14 ATMOSPHERES FOR 5 TO 8 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17206285 ↗
• MalfunctionJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH CHEST PAIN AND PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. THE 90% STENOSED, 3.5X25, CONCENTRIC, DE NOVO TARGET LESION WITH A BEND OF <=45 DEGREES WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED ON THE SECOND INFLATION FOR 5 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17204358 ↗
• MalfunctionMar 10, 2022Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18-FEB-2022. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, BALLOON LEAK OCCURRED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13728173 ↗
• InjuryFeb 10, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK AND PATIENT ANXIETY OCCURRED. THE PATIENT PRESENTED WITH ANGINA. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE AND THE PATIENT EXPERIENCED ANXIETY. THE DETACHED PORTION OF THE DEVICE WAS PULLED OUT OF THE BODY FOR REMOVAL, NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Anxiety

  MAUDE report 13503433 ↗
• MalfunctionDec 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80% STENOSED AND SEVERELY CALCIFIED. THE BALLOON WAS INFLATED TWICE AT 10-12 ATMOSPHERES FOR 3 SECONDS EACH. THE BALLOON RUPTURED AT 12 ATMOSPHERES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957945 ↗
• MalfunctionJul 19, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PROXIMAL SHAFT BROKE ON A 2.00MM X 20MM EMERGE BALLOON CATHETER DURING PREPARATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188174 ↗
• MalfunctionOct 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10762593 ↗
• MalfunctionAug 18, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26-JUL-2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10421208 ↗
• MalfunctionFeb 20, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER THE BALLOON WAS INFLATED TO NOMINAL PRESSURE, THE INFLATION DEVICE WOULD NOT DEFLATE THE BALLOON NOR GOING NEGATIVE ON SYRINGE TWICE. THE BALLOON WAS PULLED OUT FROM THE BODY IN INFLATED STATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9733152 ↗
• MalfunctionMay 3, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10-APR-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 87% STENOSED, 2.5X21MM, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE LESION CONTAINED LESS THAN EQUAL TO 45 DEGREES BEND. A 2.00MM X 20MM 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 PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577624 ↗
• MalfunctionApr 11, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX/OBTUSE MARGINAL ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THERE WAS DIFFICULTY PULLING THE BALLOON OVER THE WIRE. THE DEVICE WAS REMOVED TOGETHER WITH THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503758 ↗
• MalfunctionFeb 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED, 3.0-3.5MMX18-20MM TARGET LESIONN WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8313551 ↗
• MalfunctionDec 13, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. AFTER A GUIDE WIRE CROSSED THE LESION, A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON WAS WITHDRAWN ALONG WITH THE GUIDE WIRE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160993 ↗
• MalfunctionDec 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 38MMX3MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148753 ↗
• MalfunctionDec 4, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12-NOV-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 98% STENOSED, 2.0X20MM TARGET LESION WAS LOCATED IN THE SERIOUSLY TORTUOUS AND SERIOUSLY CALCIFIED RIGHT CORONARY ARTERY. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE SEPARATION. 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 THAT THE HYPOTUBE IS SEPARATED 97.6CM FROM THE HUB. THERE ARE MULTIPLE KINKS ALONG THE HYPOTUBE. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. THERE IS BLOOD PRESENT IN THE GUIDEWIRE LUMEN AND THE BALLOON IS STILL TIGHTLY FOLDED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8130215 ↗
• MalfunctionDec 3, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING AN EMERGENT TREATMENT PROCEDURE OF A CHRONIC TOTALLY OCCLUDED TARGET LESION, A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE WHILE WITHDRAWING THE BALLOON. THE PROCEDURE WAS COMPLETED WITH MULTIPLE BALLOONS AND THE IMPLANTATION OF THREE STENTS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8126048 ↗
• MalfunctionSep 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.00MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889933 ↗
• DeathJan 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2016-12259, 2134265-2016-12261, 2134265-2016-12260, 2134265-2016-12257, 2134265-2016-12256. IT WAS REPORTED THAT THE PATIENT DIED. SEVERAL DAYS PRIOR TO THIS PERCUTANEOUS CORONARY INTERVENTION (PCI), THIS PATIENT HAD A REPEAT THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR) FOR A DISSECTION IN THE AORTA. A STENT GRAFT WAS PLACED AT THAT TIME. OPEN SURGERY WAS NOT AN OPTION FOR THIS PCI DUE TO THE PATIENT¿S CONDITION. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESIONS WERE LOCATED IN THE DISTAL LEFT MAIN TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND MID LAD ARTERIES; THE DISEASE WAS NOTED TO BE COMPLEX. DURING THE PROCEDURE AN OPTICROSS¿ IMAGING CATHETER, A SAMURAI GUIDEWIRE, A 2.00MMX20MM EMERGE¿ BALLOON CATHETER AND A 8MMX4.00MM NC QUANTUM APEX¿ BALLOON CATHETER WERE USED. A 2.25X28 SYNERGY II DRUG-ELUTING STENT (DES) WAS DEPLOYED IN THE MID LAD AND A 3.50 X 16 SYNERGY II DES WAS DEPLOYED IN THE DISTAL LEFT MAIN TO PROXIMAL LAD. THE PROCEDURE WENT VERY WELL. HOWEVER, AS STAFF WAS UNDRAPING THE PATIENT AND PREPARING TO TRANSFER, THE PATIENT BEGAN TO BLEED INTERNALLY THROUGH HIS CHEST TUBE. SURGERY AND ANESTHESIA WERE CALLED AND THEY W

  Patient problems: Death

  MAUDE report 6243926 ↗