ImpulseRecalls & reported problems across all models
Boston Scientific Corporation · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 2
- Injuries reported
- 8
- Recalls
- 0
We found 13 models of Impulse by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Oct 22, 2018 and Sep 24, 2026 — classified as 2 deaths, 8 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (8 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. 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
Most reported Impulse problems
Device problems
- Tear, Rip or Hole in Device Packaging8
- Adverse Event Without Identified Device or Use Problem6
- Contamination6
- Device Contaminated During Manufacture or Shipping5
- Material Integrity Problem5
- Difficult to Advance4
- Detachment of Device or Device Component3
- Material Deformation3
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Chest Pain5
- No Consequences Or Impact To Patient4
- No Patient Involvement3
- Vascular Dissection3
- Cardiac Arrest2
- Cardiac Perforation2
- Cardiac Tamponade2
Impulse models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Impulse™ H74916391221CATHETER, INTRAVASCULAR, DIAGNOSTIC7 reports
- Impulse™ H74916391021CATHETER, INTRAVASCULAR, DIAGNOSTIC1 death6 reports
- Impulse™ H74916391411CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- Impulse™ H74916391401CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- Impulse™ H74916599220CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Impulse™ H749165993010CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impulse™ H74916599400CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Impulse™ H74916391011CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impulse™ H749163911951CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impulse™ H74916391211CATHETER, INTRAVASCULAR, DIAGNOSTIC1 death1 report
- Impulse™ H74916599240CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impulse™ H74916391421CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Impulse™ H749163911001CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
Recent Impulse adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Difficult to Remove; Material Separation; Device-Device Incompatibility
It was reported that the device was fractured.The target lesion was located in the coronary artery. An Impulse Catheter-Diagnostic was selected for use. During the procedure, upon insertion of the device outside the patient, the catheter seemed to get stuck in a non-Boston Scientific valve and was fractured. The physician was unable to unscrew the valve and pull out the rest of the catheter, so the catheter was physically cut. The procedure was completed with another of the same device. The patient is stable post procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882175 ↗MalfunctionAug 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PIGTAIL CATHETER BROKE OFF. A 5F IMPULSE CATHETER-DIAGNOSTIC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PIGTAIL PART OF THE CATHETER BROKE OFF. THERE WAS NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22715081 ↗MalfunctionJul 8, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT STERILITY WAS COMPROMISED. FIVE MODEL-5F IMPULSE FL4 (5PK) WERE SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT PART OF THE PACKAGING OF THE CATHETERS COMPLETELY CAME APART UPON TRYING TO OPEN THEM. THE SEAL REMAINED INTACT, BUT DEVICE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT COMPLICATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19692379 ↗MalfunctionJul 8, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT STERILITY WAS COMPROMISED. FIVE MODEL-5F IMPULSE FL4 (5PK) WERE SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT PART OF THE PACKAGING OF THE CATHETERS COMPLETELY CAME APART UPON TRYING TO OPEN THEM. THE SEAL REMAINED INTACT, BUT DEVICE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT COMPLICATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19691990 ↗MalfunctionJul 8, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT STERILITY WAS COMPROMISED. FIVE MODEL-5F IMPULSE FL4 (5PK) WERE SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT PART OF THE PACKAGING OF THE CATHETERS COMPLETELY CAME APART UPON TRYING TO OPEN THEM. THE SEAL REMAINED INTACT, BUT DEVICE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT COMPLICATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19691902 ↗MalfunctionJul 8, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT STERILITY WAS COMPROMISED. FIVE MODEL-5F IMPULSE FL4 (5PK) WERE SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT PART OF THE PACKAGING OF THE CATHETERS COMPLETELY CAME APART UPON TRYING TO OPEN THEM. THE SEAL REMAINED INTACT, BUT DEVICE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT COMPLICATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19691900 ↗MalfunctionJul 8, 2024Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT STERILITY WAS COMPROMISED. FIVE MODEL-5F IMPULSE FL4 (5PK) WERE SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT PART OF THE PACKAGING OF THE CATHETERS COMPLETELY CAME APART UPON TRYING TO OPEN THEM. THE SEAL REMAINED INTACT, BUT DEVICE STERILITY WAS COMPROMISED. THERE WAS NO PATIENT COMPLICATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19691859 ↗InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS THROMBUS PRESENT IN THE PATIENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PHYSICIAN SUCCESSFULLY PERFORMED THE TRANSSEPTAL PUNCTURE AND THEN INSERTED THE WAS INTO THE PATIENT. THE IMPULSE PIGTAIL CATHETER WAS INSERTED TO HELP POSITION THE WAS IN THE LAA OF THE PATIENT. THE IMPULSE PIGTAIL CATHETER WAS THEN REMOVED FROM THE PATIENT, AND IT WAS NOTED THAT THERE WERE CLOTS ALL OVER THE DEVICE. THE PHYSICIAN ASPIRATED THE WAS, BUT NO THROMBUS REMAINED IN THE PATIENT. THE PHYSICIAN CONTINUED THE PROCEDURE USING THE SAME WAS. THE WDS WAS INSERTED, AND THE CLOSURE DEVICE WAS DEPLOYED IN THE PATIENT. AFTER ALL RELEASE CRITERIA WAS MET THE CLOSURE DEVICE WAS RELEASED FROM THE CORE WIRE OF THE WDS AND SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY OTHER COMPLICATIONS AND IS EXPECTED TO MAKE A FULL RECOVERY.
Patient problems: Thrombosis/Thrombus
MAUDE report 19643570 ↗InjuryJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PIGTAIL SHEARED OFF AND SNARING OCCURRED. A 5F IMPULSE CATHETER-DIAGNOSTIC WAS SELECTED FOR USE. UPON INSERTING THE CATHETER, THE PIGTAIL PORTION OF THE CATHETER WAS COMPLETELY SHEARED OFF INTO TWO PIECES, A FEW INCHES FROM THE DISTAL TIP. THE FRAGMENT SHOT DOWN THE DESCENDING AORTA AND LODGED NEAR THE RENAL. SNARING WAS USED TO REMOVE THE FRAGMENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19511034 ↗MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT STERILITY OF THE DEVICE WAS COMPROMISED. AN IMPULSE AND EXPO GUIDE CATHETER DID ARRIVE WITH A DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS ARE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE STERILITY CAN BE COMPROMISED UPON OPENING OF THE DEVICES SINCE THE FRAGMENTS CAN FALL IN. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17294968 ↗MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN IMPULSE GUIDE CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17294474 ↗MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN IMPULSE GUIDE CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17294386 ↗MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN IMPULSE GUIDE CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17294112 ↗MalfunctionJul 7, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. UPON ARRIVAL, IT WAS NOTED THAT AN IMPULSE GUIDE CATHETER HAD DEBRIS STUCK ON ITS PACKAGING. BITS OF CARDBOARD AND OTHER FRAGMENTS WERE LODGED IN THE TOP OF THE PACKAGE AS WELL AS IN THE INSIDE OF THE INDIVIDUAL WHITE CARDBOARD PACKAGING. THE DEVICE COULD NOT BE PLACED IN A CLEAN ROOM SINCE IT WAS COVERED WITH NON-STERILE DEBRIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17278811 ↗InjuryAug 18, 2022Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT AN EMBOLIC STROKE OCCURRED RESULTING IN EXPRESSIVE APHASIA. ON (B)(6) 2022, AN IMPLUSE DIAGNOSTIC GUIDE CATHETER WAS SELECTED FOR USE IN A CORONARY INTERVENTION PROCEDURE. THE IMPLUSE TOOK 4 MINS TO CROSS THE VALVE. POST PROCEDURE, WITHIN THE SAME MONTH AS THE INITIAL PROCEDURE, THE PATIENT EXPERIENCED AN EMBOLIC STROKE REQUIRING HOSPITAL TREATMENT. THE PATIENT EXPERIENCED MEMORY LOSS AND LEFT SIDE WEAKNESS POST STROKE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Brain Injury; Muscle Weakness/Atrophy; Stroke/CVA
MAUDE report 15255055 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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