Maverick²™ H7493892815270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729370093), received between Jun 3, 2019 and Jun 9, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

5 other recalls cover devices cleared under the same FDA submission (P860019); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AORTA NON-CORONARY CUSP. A 2.75 MM X 15 MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, WHILE ACCESSING THE VALVE, THE SAFARI2 GUIDEWIRE BECAME STUCK WITHIN THE BALLOON, PREVENTING ITS REMOVAL. GIVEN THE PATIENTS SAFETY AS THE PRIMARY CONCERN, BOTH THE WIRE AND BALLOON WERE REMOVED, AND A NEW GUIDEWIRE AND BALLOON WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS STUCK WITH THE SAFARI WIRE WAS A NON-BOSTON SCIENTIFIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169510 ↗
• MalfunctionJun 3, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE INSIDE THE ARCH OF THE AORTA. THE DEVICE WAS REMOVED AND USED ANOTHER MAVERICK 2.75MM X 15MM AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663623 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P860019. One submission often covers many models, so check the product and lot details in each record.

• Z-2165-2008 · May 1, 2007 · Terminated
  Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194 Use before 2010-04 Indicated for balloon dilation of the stenotic portion o
• Z-2166-2008 · Nov 1, 2005 · Terminated
  Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm Made in Ireland Ballybrit Business Park, Galway, Ireland REF 38928-1225 Use before 2007-01 UPN H
• Z-0030-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
• Z-0031-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
• Z-0032-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151