Maverick²™ H7493892815300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729370109), received between Oct 10, 2018 and May 26, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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

• MalfunctionMay 26, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 100% STENOSED, 35X2.5MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DELIVERY SHAFT WAS FRACTURED AND IT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10088698 ↗
• MalfunctionMay 11, 2020Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 100% STENOSED, 2.5MM X 35MM, TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT WAS FRACTURED AND THE BALLOON FAILED TO CROSS THE CHRONIC TOTAL OCCLUSION LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10043330 ↗
• MalfunctionMay 8, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED OVER THE WIRE AND THROUGH THE GUIDE CATHETER; HOWEVER, SOMETHING STRANGE WERE FELT. THE BALLOON WAS RETRIEVED FROM THE GUIDE CATHETER AND IT WAS NOTED THAT THE SHAFT BROKE INTO 2 PIECES. THE BALLOON CATHETER WAS NEVER INTRODUCED INTO THE PATIENT'S BODY, ONLY INSIDE THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8590859 ↗
• MalfunctionMay 2, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER A MACH 1 GUIDING CATHETER AND A NON-BSC GUIDE WIRE WERE USED FOR CANNULATION ON THE OSTIAL TO DISTAL RCA, A 3.00MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, WHEN THE BALLOON CATHETER WAS NOT YET FULLY INSIDE THE GUIDE CATHETER, IT WAS NOTED THAT THE SHAFT BROKE 64CM FROM THE PROXIMAL SHAFT. THE DEVICE WAS SIMPLY REMOVED AND WAS REPLACED WITH A 4.0X12MM NC EMERGE BALLOON CATHETER TO OPEN THE PROXIMAL RCA AND ANOTHER 2.5X20MM MAVERICK BALLOON CATHETER WAS USED TO OPEN THE MID RCA. THE PROCEDURE WAS COMPLETED WITH PLAIN OLD BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8574892 ↗
• MalfunctionJan 15, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED MIDDLE CIRCUMFLEX (CX). A 3.00MM X 15MM MAVERICK WAS ADVANCED BUT COULDN'T REACH THE TARGET LESION BY 2CM. THE BALLOON WAS PULLED BACK INTO THE GUIDE CATHETER, AND WHILE PULLING THE DEVICE INSIDE THE GUIDE CATHETER, THE SHAFT BROKE APPROXIMATELY 25 CM FROM HUB. THE DEVICE WAS COMPLETELY LOCATED WITHIN THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8251234 ↗
• MalfunctionNov 2, 2018Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS PROXIMAL RAMUS INTERVENTRICULARIS ANTERIOR (RIVA). A 3.00 MM X 15 MM MAVERICK 2 BALLOON WAS USED TO DILATE THE LESION. THE MAVERICK 2 WAS WITHDRAWN INTO THE GUIDE CATHETER. AFTER THE MAVERICK 2 WAS PULLED OUT OF THE GUIDE CATHETER, A BROKEN SHAFT WAS NOTICED. THE GUIDE CATHETER, GUIDEWIRE, AND THE BROKEN MAVERICK 2 WERE REMOVED COMPLETELY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS: RETURNED PRODUCT CONSISTED OF THE HUB AND PROXIMAL HYPOTUBE OF A MAVERICK 2 BALLOON CATHETER. THE DISTAL PORTION OF THE HYPOTUBE, SHAFT, BALLOON AND TIP WERE NOT RETURNED. THE HYPOTUBE WAS MICROSCOPICALLY EXAMINED. THE HYPOTUBE WAS COMPLETELY SEPARATED 74.5CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACE WAS OVALED AND TORN, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THERE ARE NUMEROUS HYPOTUBE KINKS. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8034432 ↗
• MalfunctionOct 10, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.00MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE PROXIMAL END OF THE BALLOON TO THE TIP WAS MISSING. RETURNED PRODUCT CONSISTED OF A MAVERICK 2 BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, AND BALLOON WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED THE PROXIMAL END OF THE BALLOON TO THE TIP MISSING. APPROXIMATELY 3MM OF THE PROXIMAL BALLOON IS LEFT. THE DISTAL GUIDE WIRE, DISTAL BALLOON, MARKER BAND, AND TIP WERE NOT RETURNED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES CONTRIBUTING TO THE REPORTED CROSSING DIFFICULTY, WHICH COULD NOT BE CONFIRMED BECAUSE THE CLINICAL CIRCUMSTANCES COULD NOT BE REPLICATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7954576 ↗

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