NC EmergeRecalls & reported problems across all models
Boston Scientific Corporation · 61 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 456
- Deaths reported
- 3
- Injuries reported
- 98
- Recalls
- 1
We found 61 models of NC Emerge by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 456 adverse event reports in the FDA's MAUDE database, received between Feb 26, 2018 and Sep 17, 2026 — classified as 3 deaths, 98 injuries, 355 malfunctions.
The most frequently reported specific device problem is “Break” (211 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
NC 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, 2019Class IITerminated
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-0579-2020 · Root cause: Process control · names 7 of these models · Recall details · FDA record ↗
Most reported NC Emerge problems
Device problems
- Break211
- Material Rupture132
- Difficult to Remove50
- Detachment of Device or Device Component36
- Material Deformation22
- Adverse Event Without Identified Device or Use Problem19
- Entrapment of Device17
- Deflation Problem14
Patient problems
- No Clinical Signs, Symptoms or Conditions267
- No Consequences Or Impact To Patient99
- Foreign Body In Patient25
- No Known Impact Or Consequence To Patient19
- No Patient Involvement17
- Device Embedded In Tissue or Plaque10
- Chest Pain7
- No Code Available6
NC Emerge models
61 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NC Emerge® H7493926712250Catheters, transluminal coronary angioplasty, percutaneous1 recall33 reports
- NC Emerge® H7493926715300Catheters, transluminal coronary angioplasty, percutaneous1 recall32 reports
- NC Emerge® H7493926715350Catheters, transluminal coronary angioplasty, percutaneous1 recall17 reports
- NC Emerge® H7493926712400Catheters, transluminal coronary angioplasty, percutaneous1 recall11 reports
- NC Emerge® H7493926712320Catheters, transluminal coronary angioplasty, percutaneous1 recall8 reports
- NC Emerge® H7493926712270Catheters, transluminal coronary angioplasty, percutaneous1 recall7 reports
- NC Emerge® H7493926708350Catheters, transluminal coronary angioplasty, percutaneous1 recall3 reports
- NC Emerge® H7493926712300Catheters, transluminal coronary angioplasty, percutaneous40 reports
- NC Emerge® H7493926712350Catheters, transluminal coronary angioplasty, percutaneous28 reports
- NC Emerge® H7493926720300Catheters, transluminal coronary angioplasty, percutaneous23 reports
- NC Emerge® H7493926720250Catheters, transluminal coronary angioplasty, percutaneous18 reports
- NC Emerge® H7493926720350Catheters, transluminal coronary angioplasty, percutaneous1 death16 reports
- NC Emerge® H7493926715250Catheters, transluminal coronary angioplasty, percutaneous15 reports
- NC Emerge® H7493926715400Catheters, transluminal coronary angioplasty, percutaneous14 reports
- NC Emerge® H7493926708400Catheters, transluminal coronary angioplasty, percutaneous12 reports
- NC Emerge® H7493926715270Catheters, transluminal coronary angioplasty, percutaneous12 reports
- NC Emerge® H7493926712200Catheters, transluminal coronary angioplasty, percutaneous10 reports
- NC Emerge® H7493926708300Catheters, transluminal coronary angioplasty, percutaneous9 reports
- NC Emerge® H7493926708500Catheters, transluminal coronary angioplasty, percutaneous1 death8 reports
- NC Emerge® H7493926712220Catheters, transluminal coronary angioplasty, percutaneous7 reports
- NC Emerge® H7493926712450Catheters, transluminal coronary angioplasty, percutaneous7 reports
- NC Emerge® H7493926715220Catheters, transluminal coronary angioplasty, percutaneous7 reports
- NC Emerge® H7493926715450Catheters, transluminal coronary angioplasty, percutaneous7 reports
- NC Emerge® H7493926708450Catheters, transluminal coronary angioplasty, percutaneous6 reports
- NC Emerge® H7493926715200Catheters, transluminal coronary angioplasty, percutaneous1 death6 reports
- NC Emerge® H7493926715370Catheters, transluminal coronary angioplasty, percutaneous6 reports
- NC Emerge® H7493926720220Catheters, transluminal coronary angioplasty, percutaneous6 reports
- NC Emerge® H7493926708250Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Emerge® H7493926712500Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Emerge® H7493926715320Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Emerge® H7493926720200Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Emerge® H7493926720500Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Emerge® H7493926730350Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Emerge® H7493926708600Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC Emerge® H7493926712370Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC Emerge® H7493926720320Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC Emerge® H7493926720370Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC Emerge® H7493926720400Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC Emerge® H7493926708200Catheters, transluminal coronary angioplasty, percutaneous3 reports
- NC Emerge® H7493926708320Catheters, transluminal coronary angioplasty, percutaneous3 reports
- NC Emerge® H7493926720600Catheters, transluminal coronary angioplasty, percutaneous3 reports
- NC Emerge® H7493926730250Catheters, transluminal coronary angioplasty, percutaneous3 reports
- NC Emerge® H7493926706400Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Emerge® H7493926708220Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Emerge® H7493926708270Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Emerge® H7493926708550Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Emerge® H7493926712550Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Emerge® H7493926715550Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Emerge® H7493926720450Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Emerge® H7493926706300Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Emerge® H7493926706450Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Emerge® H7493926706500Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Emerge® H7493926715500Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Emerge® H7493926715600Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Emerge® H7493926720270Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Emerge® H7493926730220Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Emerge® H7493926730270Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Emerge® H7493926806350Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Emerge® H7493926815300Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Emerge® H7493926815400Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Emerge® H7493926820200Catheters, transluminal coronary angioplasty, percutaneous1 report
Recent NC Emerge adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Break
It was reported via MedWatch report 2000330000-2026-8055 that shaft break occurred, requiring additional intervention.The intended procedure included right femoral sheath side-port angiography and left heart catheterization. A complex percutaneous coronary intervention of the left main was performed involving multiple pieces of equipment. Following final post-dilatation, it was believed that the wire was unraveled and wrapped around the 5.50mm x 12mm NC Emerge balloon. The balloon catheter shaft broke at the monorail opening. The devices were recovered using a snare from the left radial access. The patient was unharmed and stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808412 ↗MalfunctionSep 3, 2026Break; Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599879 ↗InjuryAug 6, 2026Break
It was reported that shaft break occurred requiring additional intervention.The target lesion was located in a coronary artery. A 4.50mm x 6mm NC Emerge balloon catheter was advanced for dilation. However, it was noted that the balloon shaft broke. The device was removed using snare and the procedure was completed with another of same device. There were no patient complications. Patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166939 ↗MalfunctionMay 7, 2026
THE EVENT HAPPENED DURING A CTO [CHRONIC TOTAL OCCLUSION] CASE PERFORMED IN CATH LAB B. WE HAD CROSSED A WIRE THROUGH A GRAFT LEADING INTO THE RCA [RIGHT CORONARY ARTERY]. THEN A BALLOON WAS PLACED OVER THE WIRE AND LATER BROKE OFF AND DISLODGED IN THE VESSEL. WE DEPLOYED A STENT IN THE PROXIMITY OF THE BALLOON TO SECURE IT IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111496 ↗MalfunctionApr 22, 2026Material Rupture; Failure to Advance
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953119 ↗MalfunctionApr 17, 2026Difficult to Remove; Failure to Deflate
IT WAS REPORTED THAT REMOVAL DIFFICULTY AND DEFLATION ISSUE OCCURRED RESULTING IN A PROLONGED PROCEDURE. THE PATIENT WAS BEING TREATED FOR OCCLUSION AND UNDERWENT AN ANGIOPLASTY PROCEDURE. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED INSIDE THE PATIENT; HOWEVER, THE BALLOON COULD NOT BE DEFLATED, AND REMOVAL DIFFICULTY WAS EXPERIENCED. THE BALLOON WAS REMOVED FROM THE PATIENT IN THE INFLATED STATE. A SECOND 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ALSO ADVANCED; BUT THE SAME ISSUE OCCURRED, RESULTING IN PROLONGATION OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913617 ↗MalfunctionApr 17, 2026Difficult to Remove; Failure to Deflate
IT WAS REPORTED THAT REMOVAL DIFFICULTY AND DEFLATION ISSUE OCCURRED RESULTING IN A PROLONGED PROCEDURE. THE PATIENT WAS BEING TREATED FOR OCCLUSION AND UNDERWENT AN ANGIOPLASTY PROCEDURE. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED INSIDE THE PATIENT; HOWEVER, THE BALLOON COULD NOT BE DEFLATED, AND REMOVAL DIFFICULTY WAS EXPERIENCED. THE BALLOON WAS REMOVED FROM THE PATIENT IN THE INFLATED STATE. A SECOND 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ALSO ADVANCED; BUT THE SAME ISSUE OCCURRED, RESULTING IN PROLONGATION OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912536 ↗InjuryMar 30, 2026Nonstandard Device; Material Rupture; Material Separation
IT WAS REPORTED THAT BALLOON RUPTURE AND TIP DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A CALCIFIED VESSEL. A 4.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED TWICE; HOWEVER, THE PHYSICIAN BELIEVES THE BALLOON LIKELY RUPTURED DURING THE FIRST INFLATION. BECAUSE THERE WAS NO BLOOD RETURN IN THE INFLATION DEVICE, THE BALLOON WAS REINFLATED. UPON REMOVAL OF THE DEVICE, THE TIP OF THE CATHETER WAS FOUND TO BE DETACHED. THE PHYSICIAN SEARCHED FOR THE DETACHED COMPONENT UNDER X-RAY BUT WERE UNABLE TO LOCATE IT. THE PROCEDURE WAS DELAYED WHILE THE PHYSICIAN ATTEMPTED TO IDENTIFY THE MISSING TIP. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS EXPECTED TO MAKE A FULL RECOVERY.
Patient problems: Foreign Body In Patient
MAUDE report 24717415 ↗MalfunctionMar 30, 2026Break; Deformation Due to Compressive Stress
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI). A 3.50 MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON REMOVAL FROM THE HOOP, A SHAFT KINKED WAS NOTED. THE PHYSICIAN STILL DECIDED TO USE THE BALLOON, BUT A FRACTURE WAS SUBSEQUENTLY OBSERVED. THE PROCEDURE WAS PROLONGED BUT THERE WERE NO COMPLICATIONS REPORTED. THE PATIENT MADE A FULL RECOVERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714399 ↗MalfunctionMar 20, 2026Material Puncture/Hole
IT WAS REPORTED THAT SHAFT HOLE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 5.00MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED ONTO THE GUIDEWIRE. HOWEVER, IT WAS NOTED THE GUIDEWIRE EXITED DISTAL TO THE MONORAIL EXIT PORT. THE BALLOON WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER 5.0 X 20MM NC EMERGE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651066 ↗MalfunctionMar 18, 2026Material Rupture
IT WAS REPORTED THAT BALLOON BURST. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. A 4.50MM X 20MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON HAD BURST. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24631172 ↗MalfunctionMar 11, 2026Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE PUSHING THE BALLOON, THE SHAFT FRACTURED AND SEPARATED. 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 24574306 ↗InjuryMar 5, 2026Difficult to Remove; Material Separation
IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED RESULTING IN ADDITIONAL INTERVENTION. THE 3.00MM X 12MM NC EMERGE BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON GOT SNARED ON A STENT AND THE DISTAL END OF THE CATHETER SHEARED OFF IN THE VESSEL. ATTEMPTS WERE MADE TO SNARE THE BROKEN PIECE, BUT THEY WERE UNSUCCESSFUL. ST SEGMENT ELEVATION WAS NOTED, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN REMARKED THAT THE PATIENT WOULD LIKELY LOSE THAT DIAGONAL ARTERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Patient problems: Foreign Body In Patient; Non specific EKG/ECG Changes
MAUDE report 24520524 ↗InjuryFeb 26, 2026Material Rupture
IT WAS REPORTED VIA MEDSUN (B)(4) THAT BALLOON RUPTURE OCCURRED AND ADDITIONAL INTERVENTION WAS REQUIRED. THE 3.50MM X 20MM NC EMERGE BALLOON WAS SELECTED FOR USE. THE BALLOON RUPTURED INSIDE THE PATIENT DUE TO CALCIUM. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE BALLOON. AN INTRA-AORTIC-BALLOON PUMP WAS INSERTED, AND THE PATIENT WAS SENT TO SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 24457266 ↗MalfunctionFeb 23, 2026Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 2.50MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE DISTAL SHAFT TO THE BALLOON WAS FOUND TO HAVE SNAPPED. THE DEVICE WAS COMPLETELY REMOVED IN ONE PIECE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAS FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24414381 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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