Quantum™ Maverick™ H7493808015400Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729392828), received between Dec 6, 2016 and Jun 26, 2023 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED, 3.8X20, CONCENTRIC, DE NOVO TARGET LESION WITH A BEND OF <=45 DEGREES WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17204361 ↗
• MalfunctionNov 25, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS UNPACKED. HOWEVER; IT WAS FOUND FRACTURED IN TWO PIECES AND KINKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15866705 ↗
• MalfunctionJun 2, 2022Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE, HOWEVER, THE BALLOON CATHETER WAS FRACTURED AND THE DEVICE COULD NOT BE EFFECTIVELY DILATED. THE PHYSICIAN REPLACED A NEW DEVICE AND COMPLETED THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14584033 ↗
• MalfunctionMar 3, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY (RCA). A GUIDEWIRE AND A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WERE ADVANCED FOR USE; HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE FAILED TO ADVANCE. THE GUIDEWIRE WAS THEN REMOVED BUT IT WAS UNABLE TO DETACH FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664892 ↗
• MalfunctionJan 26, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THERE WAS DIFFICULTY ADVANCING THE DEVICE ON THE LESION SITE AND DIFFICULTY PULLING BACK THE BALLOON. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13361116 ↗
• MalfunctionFeb 20, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31JAN2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING PROCEDURE, THE BALLOON DELIVERY SHAFT WAS KINKED. THE DEVICE WAS STILL INTACT WHEN IT WAS REMOVED FROM THE PATIENT, AND WAS ALSO STILL INTACT WHEN PACKED FOR RETURN TO BSC. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9734384 ↗
• MalfunctionApr 26, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED, 4.0X15MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE TO DILATE THE LESION. HOWEVER, THE SHAFT WAS FRACTURED AND IT COULD NOT ENTER TO PATIENT'S BODY. 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 8556015 ↗
• MalfunctionJan 28, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-JAN-2019. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281866 ↗
• MalfunctionJan 23, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-JAN-2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. DURING PREPARATION OF A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE SHAFT WAS KINKED. 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 HYPOTUBE SEPARATION.

  Patient problems: No Patient Involvement

  MAUDE report 8272674 ↗
• MalfunctionJan 22, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-JAN-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED, BUT FAILED TO 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. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8268661 ↗
• MalfunctionJan 10, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-DEC-2018. IT WAS REPORTED THAT SHAFT KINK OCCURRED. DURING INTRODUCTION OF A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE DELIVERY SHAFT OF THE BALLOON WAS KINKED. 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 SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8234086 ↗
• MalfunctionJan 18, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED, 15X4.00MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. DURING UNPACKING OF A 4.0MM X 15MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER, IT WAS NOTED THAT THE DEVICE DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7204334 ↗
• MalfunctionJul 26, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE BALLOON RUPTURED. 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 6744110 ↗
• MalfunctionJul 12, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-JUN-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 4.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO 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. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6709523 ↗
• MalfunctionMay 5, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-APR-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.0MM X 15MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED BUT FAILED TO 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. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6547488 ↗
• MalfunctionDec 15, 2016Kinked; Kinked

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12-DEC-2016. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.0MM X 15MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING THE PROCEDURE, THE BALLOON SHAFT WAS KINKED. 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 HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6179203 ↗
• MalfunctionDec 6, 2016Break; Break

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6149451 ↗

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-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-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