Maverick²™ H7493892809200Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729369875), received between Jan 26, 2017 and Jul 10, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.00MM X 9MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT WAS BROKEN AT THE MIDDLE SEGMENT. THE BROKEN DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289774 ↗
• MalfunctionJun 13, 2023Inflation Problem; Failure to Advance; Inflation Problem; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT CROSSING DIFFICULTIES AND INFLATION FAILURE WERE ENCOUNTERED. THE MORE THAN 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. DURING THE PROCEDURE, A 2.00MM X 9MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS FAILED TO CROSS THE LESION AND WAS NOT ABLE TO INFLATE. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122475 ↗
• MalfunctionApr 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 9MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688748 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 9MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, DURING PROCEDURE, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203841 ↗
• MalfunctionMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23APR2020. A 2.00MM X 9MM MAVERICK BALLOON CATHETER WAS USED DURING A PROCEDURE. AN UNKNOWN ISSUE WAS NOTED WHILE THE DEVICE WAS INSIDE THE PATIENT AND THE DEVICE WAS REMOVED. THE PATIENT STATUS POST PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR ON THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10068222 ↗
• MalfunctionMar 4, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.00MM X 9MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, THE DEVICE FAILED TO CROSS DUE TO CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8388034 ↗
• MalfunctionAug 24, 2018Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMPLEXLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.00MM X 9MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION BUT RESISTANCE WAS ENCOUNTERED. THE DEVICE WAS COMPLETELY REMOVED AND IT WAS NOTED THAT THE DISTAL SEGMENT OF THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED USING A MAVERICK BALLOON CATHETER WITH A SMALLER DIAMETER. HOWEVER, WHILE MANIPULATING THE BALLOON FOR DECONTAMINATION, THE CATHETER BROKE AND THE PORTIONS THAT WERE ORIGINALLY BENT WERE SEPARATED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813759 ↗
• MalfunctionJun 4, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 2.00MM X 9MM MAVERICK²¿ BALLOON CATHETER, UPON WIRING THE BALLOON, IT WAS NOTED THAT THE BALLOON SNAPPED OFF. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Patient Involvement

  MAUDE report 7566965 ↗
• MalfunctionDec 11, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WITH A BEND OF BETWEEN 45 AND 90 DEGREES WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.00MM X 9MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7106085 ↗
• MalfunctionJul 18, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-JUN-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE ECCENTRIC TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX) WITH LESION BEND BETWEEN 45 AND 90 DEGREES. A 2.00MM X 9MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED FOR DILATION BUT THE DEVICE FAILED TO CROSS THE LESION AFTER THREE ATTEMPTS. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2MMX10MM BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6722248 ↗
• MalfunctionJul 12, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-JUN-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE PATIENT WAS DIAGNOSED WITH SINGLE VESSEL DISEASE (SVD). VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED, 2.5X17MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. AFTER A NON-BSC GUIDE WIRE CROSSED THE LESION, A 2.00MM X 9MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE LESION AND AFTER SO MANY EFFORTS, THE DEVICE WAS REMOVED. PRE-DILATATION WAS THEN PERFORMED WITH A 1.50X8MM APEX PUSH BALLOON CATHETER, FOLLOWED BY THE IMPLANTATION OF A 2.50X20MM PROMUS ELEMENT STENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE AND RESPONDING WELL TO MEDICINES. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL BALLOON TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6709751 ↗
• MalfunctionJun 28, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 9MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6673830 ↗
• MalfunctionMay 31, 2017Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-MAY-2017. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE 75% STENOSED, 22MM IN LENGTH, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, SEVERELY CALCIFIED, AND 3.00MM IN DIAMETER RIGHT CORONARY ARTERY (RCA). THE LESION CONTAINED >45 AND <90 DEGREES BEND. AFTER A NON-BSC GUIDE CATHETER WAS ENGAGED AND A NON-BSC GUIDE WIRE CROSSED THE LESION, A 2.00MM X 9MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. THE BALLOON WAS INFLATED TWICE; HOWEVER, WHEN THE BALLOON WAS INFLATED AT 8 ATMOSPHERES, IT WAS NOTED THAT THE BALLOON COULD NOT BE INFLATED. THE DEVICE WAS REMOVED FROM THE PATIENT FULLY DEFLATED AND INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL BALLOON TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6603253 ↗
• MalfunctionJan 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 2.00MM X 9MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION BUT FAILED TO CROSS. HOWEVER, A VESSEL DISSECTION WAS NOTICED IN THE RCA. THE PHYSICIAN THEN REFERRED THE PATIENT FOR CORONARY ARTERY BYPASS GRAFT (CABG). NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Intimal Dissection

  MAUDE report 6278677 ↗

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