Quantum™ Maverick™ H7493808008400Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729392606), received between Dec 15, 2016 and Jan 2, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Break

  IT WAS REPORTED THAT A DETACHMENT OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 4.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE DEVICE WAS FRACTURED AFTER UNPACKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946097 ↗
• MalfunctionApr 23, 2025Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 4.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. A NON-BOSTON SCIENTIFIC 6F GUIDE CATHETER AND A GUIDE CATHETER EXTENSION WERE ALSO USED. DURING ADVANCEMENT, THE DEVICE SHAFT BECAME KINKED, LEADING TO INCREASED RESISTANCE. AN ATTEMPT WAS MADE TO STRAIGHTEN THE SHAFT; HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE. AN ATTEMPT WAS MADE TO STRAIGHTEN THE KINKED SHAFT, AND A RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE DEVICE WAS NORMALLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE THROUGHOUT AND FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21888172 ↗
• MalfunctionAug 10, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH UNSTABLE ANGINA PECTORIS AND UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 4.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS PREPARED FOR POST-DILATION. HOWEVER, DURING UNPACKING THE ANTERIOR HALF OF THE BALLOON CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503297 ↗
• MalfunctionOct 5, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED AT THE LEFT MAIN CORONARY ARTERY. A 4.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, 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 STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579281 ↗
• MalfunctionNov 12, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28OCT2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 90% STENOSED, 4.0 X 8MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR USE; HOWEVER, DURING PROCEDURE, THE BALLOON DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830102 ↗
• MalfunctionAug 13, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, UPON CROSSING THE LESION, THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10404739 ↗
• MalfunctionJan 29, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JAN2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 93% STENOSED, 4X10MM TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE THE BALLOON DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9643313 ↗
• MalfunctionDec 6, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED ON A CORONARY ARTERY. A 4.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED; HOWEVER, SHAFT BREAK WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9430394 ↗
• MalfunctionNov 6, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 4.0MM X 8MM BALLOON CATHETER IT WAS NOTED THAT THE DELIVERY SHAFT WAS FRACTURED ABOUT 50CM AWAY FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9288669 ↗
• MalfunctionOct 1, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY AND WAS DIRECTLY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY INTERVENTION PERFORMED. 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 9141132 ↗
• MalfunctionJul 29, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08JUL2019. IT WAS REPORTED THAT SHAFT KINKED OCCURRED. THE 85% STENOSED, 30-33MMX4.0-5.0MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.0MM X 8MM QUANTUM MAVERICK BALLON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8837852 ↗
• MalfunctionJun 21, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 75% STENOSED, 10 MM X 4 MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.0 MM X 8 MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DELIVERY SHAFT WAS FRACTURED 60 CM FROM THE DISTAL END OF THE BALLOON. THE DEVICE WAS COMPLETELY REMOVED AND 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 8722160 ↗
• MalfunctionJun 6, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14MAY2019. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE 10MM IN LENGTH TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED 4.0MM IN DIAMETER RIGHT CORONARY ARTERY. A 4.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION, 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 SHAFT SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8677139 ↗
• MalfunctionDec 12, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 16NOV2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED. 12MMX4MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A 4.0MM X 8MM 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 SHAFT DETACHMENT. DEVICE EVALUATED BY MANUFACTURER: THE RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED THAT THE HYPOTUBE IS SEPARATED 89CM FROM THE HUB. THE SEPARATION IN THE HYPOTUBE APPEARS TO HAVE BEEN KINKED PRIOR TO SEPARATION. THERE ARE MULTIPLE KINKS ALONG THE HYPOTUBE. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. THERE IS BLOOD PRESENT IN THE INFLATION LUMEN, GUIDEWIRE LUMEN AND BALLOON FOLDS. THE BALLOON IS STILL TIGHTLY FOLDED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8154538 ↗
• MalfunctionAug 22, 2017Kinked; Kinked

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02AUG2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 75% STENOSED, 8 MM IN LENGTH TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, MILDLY CALCIFIED AND 3.8 MM IN DIAMETER LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.0 MM X 8 MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT OF THE DEVICE GOT KINKED AT ABOUT 40 CM AWAY FROM THE HUB. 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 6811116 ↗
• MalfunctionAug 11, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 4.0MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE TIP FRACTURED. THE FRACTURED TIP WAS REMOVED TOGETHER WITH THE GUIDE CATHETER FROM THE PATIENT'S BODY. 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 6788291 ↗
• MalfunctionJul 23, 2017Kinked; Kinked

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15-JULY-2017. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.0 MM X 8 MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE DEVICE DELIVERY SHAFT WAS KINKED. 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 A HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6734966 ↗
• MalfunctionMay 5, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.0 MM X 8 MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, 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 THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6549192 ↗
• MalfunctionMar 23, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.0 MM X 8 MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE DELIVERY 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 Consequences Or Impact To Patient

  MAUDE report 6430278 ↗
• MalfunctionDec 15, 2016Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 18MM X 3.5MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.0MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, IT WAS NOTED THAT THE SHAFT HAD FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND 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 6178460 ↗

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