Wolverine Coronary Cutting BalloonRecalls & reported problems across all models
Boston Scientific Corporation · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 206
- Deaths reported
- 1
- Injuries reported
- 31
- Recalls
- 0
We found 22 models of Wolverine Coronary Cutting Balloon by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 206 adverse event reports in the FDA's MAUDE database, received between Feb 20, 2018 and Sep 14, 2026 — classified as 1 death, 31 injuries, 174 malfunctions.
The most frequently reported specific device problem is “Break” (112 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 Wolverine Coronary Cutting Balloon problems
Device problems
- Break112
- Material Rupture34
- Difficult to Remove24
- Difficult to Advance18
- Adverse Event Without Identified Device or Use Problem17
- Detachment of Device or Device Component17
- Failure to Advance14
- Material Deformation13
Patient problems
- No Clinical Signs, Symptoms or Conditions107
- No Consequences Or Impact To Patient68
- Vascular Dissection6
- Foreign Body In Patient5
- No Known Impact Or Consequence To Patient5
- Insufficient Information3
- No Code Available3
- Device Embedded In Tissue or Plaque2
Wolverine Coronary Cutting Balloon models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Wolverine Coronary Cutting Balloon H74939401103000Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring1 death36 reports
- Wolverine Coronary Cutting Balloon H74939401103500Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring21 reports
- Wolverine Coronary Cutting Balloon H74939401104000Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring19 reports
- Wolverine Coronary Cutting Balloon H74939401153000Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring19 reports
- Wolverine Coronary Cutting Balloon H74939401153500Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring19 reports
- Wolverine Coronary Cutting Balloon H74939401102500Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring16 reports
- Wolverine Coronary Cutting Balloon H74939401154000Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring15 reports
- Wolverine Coronary Cutting Balloon H74939401063000Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring9 reports
- Wolverine Coronary Cutting Balloon H74939401062500Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring8 reports
- Wolverine Coronary Cutting Balloon H74939401102000Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring7 reports
- Wolverine Coronary Cutting Balloon H74939401152500Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring7 reports
- Wolverine Coronary Cutting Balloon H74939401102750Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring6 reports
- Wolverine Coronary Cutting Balloon H74939401102250Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring5 reports
- Wolverine Coronary Cutting Balloon H74939401103250Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring5 reports
- Wolverine Coronary Cutting Balloon H74939401103750Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring3 reports
- Wolverine Coronary Cutting Balloon H74939401062750Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring2 reports
- Wolverine Coronary Cutting Balloon H74939401063250Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring2 reports
- Wolverine Coronary Cutting Balloon H74939401064000Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring2 reports
- Wolverine Coronary Cutting Balloon H74939401152000Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring2 reports
- Wolverine Coronary Cutting Balloon H74939401062000Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring1 report
- Wolverine Coronary Cutting Balloon H74939401062250Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring1 report
- Wolverine Coronary Cutting Balloon H74939401063500Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring1 report
Recent Wolverine Coronary Cutting Balloon adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Fluid/Blood Leak; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757894 ↗MalfunctionSep 1, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550331 ↗InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient complications occurred.The patient presented for planned percutaneous coronary intervention. The 80% in-stent restenosed target lesion was located from the mid to distal LAD. The target lesion was pre-treated with a 2.50 x 6 mm Wolverine cutting balloon. Following pre-treatment with the Wolverine balloon, a dissection and spasm were observed and were treated with nitroglycerin and a 2.00 x 12 mm Agent DCB balloon inflated to 4 ATM. After treatment with the Agent DCB, the angiographic appearance normalized. The lesion was then successfully treated with additional 3.00 x 12 mm and 2.50 x 20 mm Agent DCB devices. The patient tolerated the procedure well and was discharged home in stable condition.
Patient problems: Vascular Dissection; Vasospasm
MAUDE report 50246804 ↗MalfunctionAug 14, 2026Device-Device Incompatibility; Device Dislodged or Dislocated
It was reported that the blades were opened.The target lesion was located in the coronary artery. A 10mmX4.00mm Wolverine Coronary Cutting Balloon was selected for use. During preparation, at removal from the package, the physician observed that the blades appeared winged/opened. During use, the balloon was unable to cross through the 6F guide catheter. The procedure was completed with another of the same device. There were no patient complications, and the patient was in good condition after the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245618 ↗MalfunctionJul 28, 2026Nonstandard Device; Material Rupture
It was reported that the balloon burst.A 10mmX3.00mm Wolverine Coronary Cutting Balloon was selected for use. During the procedure, at first inflation, it was noted that the balloon burst. The device was removed without any problem using the normal method and the procedure was completed with another of the same device. There were no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059188 ↗InjuryJul 28, 2026Break; Difficult to Remove
It was reported that the balloon wires broke apart.A two 15mmX3.00mm Wolverine Coronary Cutting Balloon were selected for treatment. During the procedure it was noted that the balloon wires broke apart. Removal of the wire percutaneously were unsuccessful. An incision had to be made to remove the broken wires. There were no patient complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059135 ↗InjuryJul 28, 2026Break; Difficult to Remove
It was reported that the balloon wires broke apart.A two 15mmX3.00mm Wolverine Coronary Cutting Balloon were selected for treatment. During the procedure it was noted that the balloon wires broke apart. Removal of the wire percutaneously were unsuccessful. An incision had to be made to remove the broken wires. There were no patient complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059134 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a dissection type C occurred.The patient was on a prior regimen of Aspirin (>= 72 hours). Before the procedure, the patient received Heparin or other antithrombotic medication and a loading dose of 81 mg of Aspirin. The 2.5 mm x 40 mm target lesion located at the proximal circumflex vessel was pretreated with two devices using the largest balloon diameter 3.0 mm x 30 mm Wolverine cutting balloon and semi-compliant balloon angioplasty catheter resulting in 10% residual stenosis and TIMI flow of 3. The target lesion was then successfully implanted with a 2.5 mm x 38 mm Synergy XD stent achieving 10% stenosis and TIMI flow 3. During the same day of the procedure, it was discovered that post-treatment with the 3.0 mm x 30 mm Wolverine cutting balloon and semi-compliant balloon angioplasty catheter a Grade C dissection with a dissection length of 4.21 mm and dissection stenosis of 34.09% in segment with TIMI Flow 3. No dissection was noted post treatment with the 2.50 mm x 38 mm Synergy XD drug eluting stent. The non-target lesion located at the mid-left anterior descending vessel was also treated prior to the target lesion procedure. It was successfully treated wit
Patient problems: Vascular Dissection
MAUDE report 50057669 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 15MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS USED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, WHEN THE DEVICE WAS DELIVERED TO THE LESION, IT WAS NOTED THAT THE SHAFT BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT IN TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25158613 ↗MalfunctionMar 23, 2026Nonstandard Device; Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED DURING FIRST INFLATION. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, AND PROCEDURE WAS COMPLETED WITH A NEW BALLOON. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24671119 ↗MalfunctionMar 19, 2026Break; Nonstandard Device
IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED OSTIAL RIGHT CORONARY ARTERY (RCA). A 3.00MM X 10MM WOLVERINE CORONARY CUTTING BALLOON WAS USED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING INSERTION, THE WOLVERINE DEVICE WAS ADVANCED INTO POSITION TO TREAT THE LESION. HOWEVER, THE MID SEGMENT OF THE DELIVERY STAINLESS STEEL DELIVERY SHAFT SNAPPED AND BROKE APART. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641789 ↗MalfunctionMar 18, 2026Inflation Problem; Material Separation
IT WAS REPORTED THAT BALLOON BLADE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.00MM X 15MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER 3-4 ATTEMPTS, THERE WAS NO DEPLOYMENT AND THERE WERE NO ATHEROTOMES ON THE DEVICE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO COMPLICATIONS AND PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630431 ↗InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. MULTIPLE INFLATIONS WITH A NON-BOSTON SCIENTIFIC LITHOTRIPSY BALLOON WERE USED TO SIZE THE LESION AT 4.00 MM. AN OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. THE 10 MM X 4.00 MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL WAS THEN INTRODUCED AND DURING THE SECOND INFLATION OF THE BALLOON, A VESSEL PERFORATION WAS NOTED. THE PATIENT BLOOD PRESSURE DROPPED WITH NO ASSOCIATED PAIN AT THE TIME OF THE PERFORATION. ANOTHER BALLOON WAS TEMPORARILY USED TO COVER THE PERFORATION, AND A COVERED STENT WAS SUBSEQUENTLY DEPLOYED TO SEAL IT. IVUS IMAGING WAS THEN PERFORMED TO CONFIRM THAT THE STENT COMPLETELY COVERED THE PERFORATION. THERE WERE NO FURTHER COMPLICATIONS. THE PATIENT RECOVERED AND WAS DISCHARGED THREE DAYS LATER.
Patient problems: Low Blood Pressure/ Hypotension; Perforation
MAUDE report 24508294 ↗MalfunctionFeb 17, 2026Difficult to Remove; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE BALLOON BLADE WAS LIFTED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AT 12 ATMOSPHERES. DURING REMOVAL, IT WAS FULLY DEFLATED; HOWEVER, THERE WAS DIFFICULTY REMOVING BALLOON FROM THE GUIDE. ONE BLADE DID NOT REWRAP AND APPEARED TO BE STICKING OUT. THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. THERE WERE NO COMPLICATIONS AND PATIENT FULLY RECOVERED POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370067 ↗MalfunctionFeb 11, 2026Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 10MM X 3.50MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL WAS SELECTED FOR USE. DURING WITHDRAWAL OF THE WOLVERINE, IT WAS NOTED THAT THE SHAFT BROKE IN HALF NOT UNTIL IT WAS OUTSIDE OF PATIENT'S BODY. THE DEVICE WAS REMOVED AS NORMAL. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312134 ↗
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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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