Quantum™ Maverick™ H7493808012370Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729392705), received between Nov 15, 2016 and Jun 28, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT INFLATION FAILURE OCCURRED. THE 90% STENOSED, 30MM IN LENGTH TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT LESS THAN 20 ATMOSPHERES, THE BALLOON FAILED TO INFLATE. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633878 ↗
• MalfunctionAug 31, 2021Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25AUG2021. IT WAS REPORTED THAT INFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SLIGHTLY TORTUOUS AND MODERATELY CALCIFIED 15MM IN LENGTH AND 3.75MM IN DIAMETER MID LEFT ANTERIOR DESCENDING ARTERY. A 3.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON COULD NOT FULLY INFLATE AND COULD NOT OPPOSE THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393487 ↗
• MalfunctionNov 30, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 3.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE BALLOON WAS FRACTURED. 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 Patient Involvement

  MAUDE report 10919536 ↗
• MalfunctionNov 11, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, IT WAS NOTICED THAT THE DELIVERY SHAFT WAS FRACTURED FROM ITS MIDSECTION. THE DEVICE WAS REMOVED BY SIMPLY PULLING IT OUT FROM THE PATIENT'S BODY AND 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 10823710 ↗
• MalfunctionOct 22, 2020Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CHEST. A 3.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE SHAFT OF THE CATHETER WAS KINKED AND NOT A BALLOON RUPTURE AS WHAT WAS PREVIOUSLY REPORTED. THE DEVICE WAS REMOVED WITHIN THE GUIDECATHER AND COMPLETELY REMOVED FROM THE PATIENTS BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10720662 ↗
• MalfunctionJun 24, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MIDDLE OF THE LEFT ANTERIOR DESCENDING ARTERY. A 3.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, BEFORE USAGE, THE DELIVERY SHAFT WAS FRACTURED. 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 10189757 ↗
• MalfunctionApr 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 88% STENOSED, 28-32MMX4.0-4.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING FIRST INFLATION AND THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY INTERVENTION PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946744 ↗
• MalfunctionJul 31, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09JUL2019. IT WAS REPORTED THAT SHAFT KINKED OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. DURING THE PROCEDURE, A 3.75MM X 12MM QUANTUM WAS NOTED TO HAVE A SHAFT KINK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 8846575 ↗
• MalfunctionMar 21, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.75MM X 12MM 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 SEPARATED HYPOTUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8440898 ↗
• MalfunctionNov 1, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12-OCT-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. DEVICE EVALUATED BY MANUFACTURER: THE TARGET LESION WAS LOCATED IN THE SERIOUSLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 3.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT UNABLE 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 THAT COULD GO INTO THE PATIENT'S BODY. THE DEVICE WAS RETURNED FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER. THE RETURNED DEVICE SEPARATED UPON UNPACKING WHEN RECEIVED. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED THAT THE HYPOTUBE IS SEPARATED AT 53.3CM FROM THE HUB AND APPEARED TO BE KINKED PRIOR TO SEPARATION. THERE ARE MULTIPLE KINKS ALONG THE WHOLE DEVICE. MICROSCOPIC EXAMINATION REVEALED THAT THE TIP IS DAMAGED. THERE IS CONTRAST PRESENT IN THE INFLATION LUMEN AND BALLOON. THERE IS BLOOD PRESENT IN THE GUIDEWIRE LUMEN AND THE BALLOON IS LO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8028803 ↗
• MalfunctionSep 26, 2018Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. WHEN THE 3.75MM X 12MM QUANTUM MAVERICK WAS REMOVED FROM THE PACKAGING, IT WAS FOUND TO BE BROKEN.

  Patient problems: No Patient Involvement

  MAUDE report 7911065 ↗
• MalfunctionJun 20, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26-MAY-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED AND 12MM X 3.75MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 3.75MM X 12MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.75MM X 12MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED CATHETER ENTRAPMENT AND SHAFT SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7620514 ↗
• MalfunctionFeb 15, 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 80% STENOSED, 12X3.75MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE TARGET 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 7274850 ↗
• MalfunctionJan 18, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.75MM X 12MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, THE SHAFT BROKE OVER 15CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED WITH THE GUIDE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7204221 ↗
• MalfunctionJan 16, 2017Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.75MM X 12MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHILE THE DEVICE WAS STILL OUTSIDE THE PATIENT'S BODY, THE SHAFT WAS FRACTURED. 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 Patient Involvement

  MAUDE report 6255145 ↗
• MalfunctionNov 15, 2016Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.75 MM X 12 MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON UNPACKING, IT WAS NOTED THAT THE BALLOON SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 6101384 ↗

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-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