Maverick²™ H7493892812350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729370024), received between Jan 2, 2018 and Nov 19, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Bent” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID SEGMENT OF RIGHT CORONARY ARTERY. AFTER A 6F NON-BSC GUIDE CATHETER WAS IN PLACE AND A NON-BSC GUIDEWIRE CROSSED THE LESION, A 3.50MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT BALLOON AND A STENT WAS DEPLOYED FOLLOWING POST DILATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12842426 ↗
• MalfunctionJun 24, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON OVERHANG OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50MM X 12MM MAVERICK 2 BALLOON CATHETER WAS USED FOR POST-DILATATION. HOWEVER, WHEN INFLATED, THE BALLOON GOT OVERHANG OF ALMOST 5MM OUTSIDE THE MARKERS. THE DEVICE WAS COMPLETELY REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10191752 ↗
• MalfunctionJan 2, 2018Bent; Failure to Advance; Bent; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED AND SHAFT DAMAGE OCCURRED. THE 82% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATION WITH A 3.0X12MM NON-BSC BALLOON CATHETER, A 3.50MMX12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE MID SHAFT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7159280 ↗

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-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
• Z-0031-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051