Quantum™ Maverick™ H7493808012350Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 08714729392699), received between Nov 16, 2016 and Mar 24, 2026 — classified as 4 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Break” (35 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 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 12MM QUANTUM? MAVERICK? BALLOON CATHETER WAS ADVANCED FOR USED. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674472 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, SHAFT WAS FRACTURED DURING DELIVERY. 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 23680319 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON DELIVERY SHAFT WAS FRACTURED, AND THE FRACTURED PART WAS REMOVED FROM THE PATIENT. 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 23442114 ↗
• MalfunctionSep 17, 2025Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK AND BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A SHUNT GRAFT IN A MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. FOLLOWING STENT IMPLANTATION, A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING THE DELIVERY OF THE CATHETER, THE DELIVERY SYSTEM WAS FRACTURED, AND THE PROCEDURE TOOK LONGER DUE TO THE BALLOON RUPTURE. THE DEVICE WAS PROMPTLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077854 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884175 ↗
• MalfunctionNov 20, 2024Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-NOV-2024. IT WAS REPORTED THAT CROSSING DIFFICULTIES OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PINHOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735581 ↗
• MalfunctionNov 29, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.5MM X 12MM FG QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS ABOUT TO INSERT FROM THE GUIDE CATHETER, THE SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18224546 ↗
• InjuryMar 30, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN NON-TORTUOUS AND MILDLY CALCIFIED LEFT CORONARY ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING THE INSERTION THE REAR PART OF THE DELIVERY SHAFT WAS SEPARATED IN TWO PIECES. THE DEVICE WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13950525 ↗
• MalfunctionMar 2, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653753 ↗
• MalfunctionOct 13, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION. HOWEVER, THE PHYSICIAN FOUND THAT THE BALLOON WAS FRACTURED AFTER OPENING THE INNER PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THAT THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628442 ↗
• MalfunctionJun 15, 2021Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT INFLATION FAILURE OCCURRED. THE 4.1 X 22 MM, 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). FOLLOWING STENT IMPLANTATION, A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE COULD NOT BE PRESSURIZED TO DILATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12003306 ↗
• MalfunctionApr 8, 2021Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT SHAFT DAMAGE OCCURRED. DURING PREPARATION OF A 3.50MM X 12MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE DELIVERY SHAFT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS HYPOTUBE SEPARATION. THIS EVENT WAS REPORTED IN ERROR. THE COMPLAINT DEVICE WAS A 2.00MM X 15MM FG MAVERICK 2 MR BALLOON CATHETER AND NOT A 3.50MM X 12MM QUANTUM MAVERICK BALLOON CATHETER. THERE WAS NO DEVICE RETURNED FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636069 ↗
• MalfunctionJan 11, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION AND WAS INITIALLY INFLATED. HOWEVER, DURING PREPARATION FOR SECOND DILATION, THE BALLOON FAILED TO DEFLATE WHILE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

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

  MAUDE report 11148336 ↗
• MalfunctionDec 23, 2020Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16-DEC-2020. IT WAS REPORTED THAT SLOW BALLOON INFLATION OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE LEFT CIRCUMFLEX CORONARY ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS USED. HOWEVER, THE BALLOON COULD NOT FULLY INFLATE. THE DEVICE WAS REMOVED AND 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 DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11064940 ↗
• MalfunctionDec 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED, 3.5MMX13MM TARGET LESION WAS LOCATED IN THE MODERATEY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE FIRST INFLATION AT 15 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE RUPTURED PART DID NOT REMAIN IN THE PATIENT'S BODY. 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 10954494 ↗
• MalfunctionNov 17, 2020Inflation Problem; Failure to Advance; Inflation Problem; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28OCT2020. IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE AND FAILED TO CROSS THE LESION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT MAIN ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING PROCEDURE, THE DEVICE COULD NOT CROSS THE LESION AND THE BALLOON COULD NOT BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED SHAFT SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10853269 ↗
• MalfunctionSep 22, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT THE DELIVERY SHAFT BROKE IN TWO PIECES. THE DEVICE WAS REMOVED BY SIMPLY PULLING IT OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10571182 ↗
• MalfunctionSep 10, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE DELIVERY SHAFT WAS FRACTURED AND THE DEVICE COULD NOT BE ADVANCED. THE DEVICE WAS COMPLETELY REMOVED BY SIMPLY PULLING OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515609 ↗
• MalfunctionAug 11, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE DELIVERY SHAFT WAS FRACTURED. 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 10393488 ↗
• MalfunctionJul 29, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS SIMPLY PULLED OUT, WITHOUT ANY INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10341096 ↗
• MalfunctionJul 29, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MIDDLE RIGHT CORONARY ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY BY SIMPLY PULLING IT OUT 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 10341023 ↗
• MalfunctionJul 16, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE DEVICE WAS FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10282743 ↗
• MalfunctionApr 13, 2020Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE CATHETER 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 9954687 ↗
• MalfunctionDec 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. DURING THE PROCEDURE AND WHILE THE 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS OUTSIDE THE PATIENT, IT WAS NOTED THAT THE TIP OF THE BALLOON WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9448742 ↗
• MalfunctionNov 6, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18OCT2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE SHAFT KINKED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9284226 ↗

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