EmergeRecalls & reported problems across all models
Boston Scientific Corporation · 54 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 476
- Deaths reported
- 7
- Injuries reported
- 45
- Recalls
- 1
We found 54 models of Emerge by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 476 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2017 and Sep 18, 2026 — classified as 7 deaths, 45 injuries, 424 malfunctions.
The most frequently reported specific device problem is “Break” (208 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Emerge recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 24, 2019Terminated
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Z-0577-2020 · Root cause: Process control · names 7 of these models · Recall details · FDA record ↗
Most reported Emerge problems
Device problems
- Break208
- Material Rupture99
- Adverse Event Without Identified Device or Use Problem28
- Material Deformation25
- Difficult to Remove24
- Detachment of Device or Device Component23
- Entrapment of Device22
- Failure to Advance22
Patient problems
- No Clinical Signs, Symptoms or Conditions247
- No Consequences Or Impact To Patient161
- No Patient Involvement23
- No Known Impact Or Consequence To Patient14
- Foreign Body In Patient11
- Cardiac Arrest6
- Low Blood Pressure/ Hypotension6
- Chest Pain4
Emerge models
54 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Emerge™ H7493918912200Catheters, transluminal coronary angioplasty, percutaneous1 recall3 deaths54 reports
- Emerge™ H7493918915200Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death54 reports
- Emerge™ H7493918912250Catheters, transluminal coronary angioplasty, percutaneous1 recall45 reports
- Emerge™ H7493918915300Catheters, transluminal coronary angioplasty, percutaneous1 recall21 reports
- Emerge™ H7493918915250Catheters, transluminal coronary angioplasty, percutaneous63 reports
- Emerge™ H7493918912300Catheters, transluminal coronary angioplasty, percutaneous1 recall12 reports
- Emerge™ H7493918915150Catheters, transluminal coronary angioplasty, percutaneous1 recall9 reports
- Emerge™ H7493918915350Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death9 reports
- Emerge™ H7493918920250Catheters, transluminal coronary angioplasty, percutaneous32 reports
- Emerge™ H7493918920200Catheters, transluminal coronary angioplasty, percutaneous1 death23 reports
- Emerge™ H7493918920300Catheters, transluminal coronary angioplasty, percutaneous18 reports
- Emerge™ H7493919108200Catheters, transluminal coronary angioplasty, percutaneous12 reports
- Emerge™ H7493918908200Catheters, transluminal coronary angioplasty, percutaneous11 reports
- Emerge™ H7493918930250Catheters, transluminal coronary angioplasty, percutaneous1 death9 reports
- Emerge™ H7493918920220Catheters, transluminal coronary angioplasty, percutaneous6 reports
- Emerge™ H7493918908150Catheters, transluminal coronary angioplasty, percutaneous6 reports
- Emerge™ H7493919108150Catheters, transluminal coronary angioplasty, percutaneous5 reports
- Emerge™ H7493918912220Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Emerge™ H7493918912350Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Emerge™ H7493918920150Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Emerge™ H7493918908120Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Emerge™ H7493918908300Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Emerge™ H7493919115250Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Emerge™ H7493919108250Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Emerge™ H7493918912150Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493918912400Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493918915120Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493918930200Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493918930300Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493918930400Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493918908250Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493919112150Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493919112200Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493919112250Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493919115150Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493919115200Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Emerge™ H7493918912120Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Emerge™ H7493918912270Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Emerge™ H7493918915270Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Emerge™ H7493918930350Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Emerge™ H7493919120200Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Emerge™ H7493918915220Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493918915400Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493918920120Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493918920270Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493918920350Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493918920400Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493918908350Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493919115120Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493919115400Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493919120120Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493919120150Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493919130220Catheters, transluminal coronary angioplasty, percutaneous1 report
- Emerge™ H7493919108120Catheters, transluminal coronary angioplasty, percutaneous1 report
Recent Emerge adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Fluid/Blood Leak; Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828663 ↗MalfunctionAug 20, 2026Fluid/Blood Leak; Material Rupture
It was reported that balloon rupture occurred.The 82% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery. A 1.50mm X 8mm Emerge? balloon catheter was prepared for dilatation. However, due to poor sealing the balloon has ruptured and observed a water leaking. The procedure was completed with another of the same device. There were no patient complications, and the patient condition is stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50360113 ↗MalfunctionAug 16, 2026Break; Nonstandard Device; Difficult to Remove; Device-Device Incompatibility
It was reported that removal difficulties and shaft break occurred.The patient presented with a thrombus in the saphenous vein graft (SVG) to the diagonal artery and underwent percutaneous coronary intervention. The origin of the SVG was difficult to cannulate, and the vessel was moderately tortuous without calcification. The thrombus was described as severe and required thrombectomy with a non-Boston Scientific (BSC) thrombectomy device. A 2.00mm X 15mm Emerge balloon catheter was used to block a branch from thrombus while tissue plasminogen activator was being delivered through a non-BSC guide extension catheter. A non-BSC guide catheter was used and was not coaxial to the SVG ostium. Although a lot of push was required, the balloon was delivered to the intended branch and inflated. During withdrawal, the distal shaft broke and the device appeared to be stuck within the non-BSC guide catheter/non-BSC guide extension catheter. The device was in two pieces but was removed together with the non-BSC guide catheter and non-BSC guide extension catheter. There were no patient complications, and the patient outcome was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263549 ↗MalfunctionAug 11, 2026Material Rupture; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216492 ↗DeathJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient death occurred.The patient underwent percutaneous coronary intervention (PCI) to the diagonal artery and then returned four days later for a PCI to the left anterior descending artery (LAD). During the second procedure, the LAD was successfully wired, the OptiCross imaging catheter was used for intravascular ultrasound (IVUS) examination of the target lesion without issue. It was noted that the motor drive used during IVUS appeared to make a strained noise when the catheter was running and being flushed at the same time. IVUS images were clear. A 2.00 x 12mm Emerge catheter was used to balloon the artery. Following the second balloon inflation, the patient became hypotensive and lost blood pressure. CPR was initiated immediately; however, the patient did not recover. The official cause of death was asystole.
Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension
MAUDE report 50091055 ↗MalfunctionJul 19, 2026Break; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25867987 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON CATHETER BROKE PRIOR TO REACHING THE LESION. THE BALLOON WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25044653 ↗MalfunctionApr 21, 2026Deflation Problem; Failure to Advance
IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. A 2.50MM X 30MM EMERGE BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, THE BALLOON DID NOT DEFLATE ENTIRELY WHEN PULLING NEGATIVE. THE BALLOON WAS PREPPED AGAIN, AND IT WOULD NOT CROSS THE LESION. THE PROCEDURE WAS THEN COMPLETED USING A DIFFERENT DEVICE, AND IT WORKED FINE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939779 ↗MalfunctionApr 8, 2026Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON CATHETER BROKE WHILE INSERTING INTO THE SHEATH. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818940 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50MM X 8MM EMERGE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND THAT THE SHAFT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507310 ↗MalfunctionMar 3, 2026Nonstandard Device; Failure to Advance
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10FEB2026. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 8MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR TREATMENT BUT COULD NOT PASS THROUGH THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON LONGITUDINAL TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498625 ↗MalfunctionFeb 26, 2026Material Integrity Problem
IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE 4.00MM X 15MM EMERGE MR BALLOON CATHETER WAS SELECTED FOR USE. DURING AN ATTEMPT TO ADVANCE THE BALLOON OVER THE BACK END OF A NON-BOSTON SCIENTIFIC GUIDEWIRE, THE WIRE EXITED THROUGH THE BALLON. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456299 ↗MalfunctionFeb 11, 2026Break; Nonstandard Device
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH A CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE OFF IN THE CORONARY ARTERY. ANOTHER 1.20MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED; BUT THE BALLOON ALSO BROKE OFF IN THE CORONARY ARTERY. THE DEVICES WERE SIMPLY REMOVED FROM THE PATIENT IN ONE PIECE, AND AN ALTERNATE DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314530 ↗MalfunctionFeb 11, 2026Break; Nonstandard Device
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH A CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BROKE OFF IN THE CORONARY ARTERY. ANOTHER 1.20MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED; BUT THE BALLOON ALSO BROKE OFF IN THE CORONARY ARTERY. THE DEVICES WERE SIMPLY REMOVED FROM THE PATIENT IN ONE PIECE, AND AN ALTERNATE DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314520 ↗MalfunctionFeb 10, 2026Fluid/Blood Leak; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 92% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 1.50MM X 8MM EMERGE? BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PREPARATION, IT WAS NOTED THAT THE BALLOON WAS RUPTURED AND LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304764 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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