Quantum™ Maverick™ H7493808008270Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729392552), received between Mar 23, 2017 and Jun 20, 2023 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT STENT IMPLANTATION DUE TO CORONARY ATHEROSCLEROTIC HEART DISEASE. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL END OF THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AFTER ENTERING THE GUIDE CATHETER FOR 70CM, IT WAS FRACTURED INTO TWO SECTIONS. THE DEVICE WAS REPLACED WITH A NEW PTCA BALLOON CATHETER AND PERFORMED VASCULAR DILATION AND STENT IMPLANTATION FOR THE PATIENT NORMALLY. THE PATIENT REPORTED IN GOOD CONDITION AND WAS DISCHARGED 5 DAYS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164281 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS FOUND THAT THE DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597471 ↗
• MalfunctionDec 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED TO DILATE THE LESION; HOWEVER, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907613 ↗
• MalfunctionDec 13, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PLACEMENT, TH DEVICE WAS FRACTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10999800 ↗
• MalfunctionOct 7, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 2.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON ADVANCING, THE MIDDLE PART OF THE SHAFT GOT FRACTURED. THE DEVICE WAS SIMPLY PULLED OUT AND WAS COMPLETELY REMOVED. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10641938 ↗
• MalfunctionMay 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 80% STENOSED, 20MMX2.75MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION ATTEMPT, THE BALLOON FAILED TO INFLATE DUE TO A PINHOLE ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10093707 ↗
• MalfunctionJul 19, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28 JUN 2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.75MM X 8MM 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'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808146 ↗
• MalfunctionMar 13, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE DISTAL END OF THE LEFT CIRCUMFLEX ARTERY. A 2.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, 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 8416316 ↗
• MalfunctionFeb 19, 2019Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON  24-JAN-2019. IT WAS REPORTED THAT FAILURE TO INFLATE WAS ENCOUNTERED.   THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX CORONARY ARTERY (LCX). A 2.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED. HOWEVER, DURING POST DILATE, BALLOON FAILED TO INFLATE AND WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8350708 ↗
• MalfunctionOct 23, 2018Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29SEP2018. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED. DEVICE EVALUATED BY MANUFACTURER: THE RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED A SEPARATION IN THE HYPOTUBE AT 84CM FROM THE HUB. THERE ARE MULTIPLE KINKS ALONG THE WHOLE DEVICE. MICROSCOPIC EXAMINATION DID NOT REVEAL ANY DAMAGES. THERE IS BLOOD PRESENT IN THE GUIDEWIRE LUMEN AND THE BALLOON IS 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 7995887 ↗
• MalfunctionOct 8, 2018Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12-SEP-2018. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON WAS UNABLE TO BE DILATED BY ENCORE INFLATION DEVICE. 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 BALLOON PINHOLE. 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 A KINK 88MM FROM THE HUB. MICROSCOPIC EXAMINATION REVEALED A PINHOLE SIZED TEAR 11MM FROM THE TIP. FURTHER EXAMINATION REVEALED THE TIP AND EXIT HUB IS DAMAGED. THE BALLOON IS LOOSELY FOLDED AND THERE IS BLOOD PRESENT IN THE SHAFT AND IN THE BALLOON. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE COMPLAINT INVESTIGATION CONCLUSION CODE IS: ADVERSE EVENT RELATED TO PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7942265 ↗
• MalfunctionDec 20, 2017Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK AND BALLOON RUPTURE OCCURRED. THE 95% STENOSED, 7MM IN LENGTH TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, MODERATELY CALCIFIED AND 2.75MM IN DIAMETER LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.75MMX8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. IT WAS ALSO NOTED THAT THE SHAFT FRACTURED AT ABOUT 70CM FROM THE HANDLE. 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 7134802 ↗
• MalfunctionDec 13, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED, 7X2.75MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 15.0 KILOPASCALS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT 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 7112719 ↗
• MalfunctionAug 9, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-AUG-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. A 2.75MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6778976 ↗
• MalfunctionApr 26, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED, 6X2.75MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED AT 1520 KILOPASCALS (KPA) FOR 30 SECONDS DURING THE INITIAL AND SECOND INFLATION. HOWEVER, DURING THE THIRD INFLATION AT 1621 KPA, THE BALLOON RUPTURED. 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 6523131 ↗
• MalfunctionApr 18, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 10APR2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75 MM X 8 MM 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 6500160 ↗
• MalfunctionMar 23, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING ADVANCING, IT WAS NOTED THAT 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 6430515 ↗

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-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