Wolverine Coronary Cutting Balloon H74939401152500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729888338), received between Jun 5, 2018 and Jan 18, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (P950020); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND DEVICE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT LEG. A 15MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN WAS DOING A PERIPHERAL ANGIOGRAM AND INFLATED THE BALLOON IN THE VESSEL MORE THAN ONCE. WHEN THE PHYSICIAN TRIED TO MOVE THE WOLVERINE BACK, THERE WAS SOME RESISTANCE. THE CATHETER GOT CAUGHT IN THE VESSEL AND BROKE. UPON REMOVAL, PART OF THE DEVICE REMAINED IN THE PERIPHERAL. THE PERIPHERAL WAS NOT LIMITED IN BLOOD FLOW NOR DID THE PATIENT NEED ANY EXTRA SURGICAL INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16195133 ↗
• MalfunctionDec 16, 2021Break; Break

  IT WAS REPORTED THAT THE DEVICE BREAK. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR ARTERY. A 15MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020988 ↗
• MalfunctionNov 9, 2021Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A BLADE BECAME LIFTED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE TARGET LESION WAS LOCATED IN THE 80% STENOSED, MILDLY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THIS 2.5MM X 15MM WOLVERINE CUTTING BALLOON WAS SELECTED AND INFLATED WITHIN THE LESION. INITIALLY REMOVAL DIFFICULTIES FROM THE LESION WERE ENCOUNTERED, BUT THE DEVICE WAS ABLE TO BE FREED. WHEN THE BALLOON WAS PULLED INTO THE GUIDE CATHETER ONE OF THE BLADES IN THE MIDDLE OF THE BALLOON BECAME PARTIALLY LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779293 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT BALLOON SHAFT BROKE. THE TARGET LESION WAS MODERATELY CALCIFIED. A 15MM X 2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS INTRODUCED AND DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON SHAFT BROKE MIDWAY OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10971436 ↗
• MalfunctionOct 30, 2018Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. DURING A PROCEDURE A 15MM X 2.5MM WOLVERINE CORONARY CUTTING BALLOON WAS BEING USED AND THE SHAFT BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES OR EFFECTS THAT OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019584 ↗
• MalfunctionAug 15, 2018Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING THE PROCEDURE, THE 15MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON SHAFT BROKE INTO TWO PIECES AT MID SHAFT. THE BROKEN DEVICE WAS CONTAINED WITHIN THE GUIDE AND THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7786986 ↗
• InjuryJun 5, 2018Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY REMOVING OCCURRED AND A CUTTING BALLOON BLADE LIFTED. THE TARGET LESIONS WERE LOCATED IN THE CIRCUMFLEX (CX) AND OBTUSE MARGINAL (OM) ARTERIES. THE ARTERIES HAD A MEDIUM AMOUNT OF CALCIFIED PLAQUE. THERE WAS A STENT PLACED IN THE CX ACROSS THE OM ARTERY OVER ONE YEAR AGO. THERE WAS A GUIDEZILLA 2 CATHETER INSIDE THE GUIDE CATHETER. THERE WAS A NON-BSC GUIDEWIRE IN THE OM AND ANOTHER NON-BSC GUIDEWIRE IN THE CX. BOTH OF THE LESIONS WERE PRE-DILATED. THEN A 2.5 X 15MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL WAS PASSED THROUGH THE EXISTING STENT STRUT WITHOUT ANY DIFFICULTIES. THE PROXIMAL OM LESION BEYOND THE STENT WAS DILATED MULTIPLE TIMES AT 12 ATMOSPHERES. WHEN THEY TRIED TO REMOVE THE WOLVERINE IT WAS STUCK IN THE LESION AREA. A SNARE WAS PLACED AROUND THE WOLVERINE AND A GUIDEZILLA 2 OVER THE WOLVERINE AND THE WOLVERINE WAS ABLE TO BE REMOVED FROM THE PATIENT. THE PROCEDURE AS FINISHED BY BALLOONING THE OM AND PLACING A STENT IN THE CX. UPON VISUAL INSPECTION, IT APPEARS THAT ONE OF THE BLADE PROXIMAL EDGES MIGHT HAVE LIFTED OFF OF THE BALLOON SURFACE. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY ILL EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7571533 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950020. One submission often covers many models, so check the product and lot details in each record.

• Z-2137-2013 · Jul 31, 2013 · Terminated
  Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angiopla
• Z-2138-2013 · Jul 31, 2013 · Terminated
  Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H74
• Z-0621-2009 · Nov 21, 2008 · Terminated
  Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No. CB0340006, 4.00mm, Sterile. Made in Ireland:
• Z-1512-06 · Jul 21, 2006 · Terminated
  Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.
• Z-0409-06 · Dec 7, 2005 · Terminated
  The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Ball
• Z-0410-06 · Dec 7, 2005 · Terminated
  The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface.