Quantum™ Maverick™ H7493808008370Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729392590), received between Jul 5, 2018 and Jul 14, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 3.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN FELT THAT THE DEVICE DID NOT ENTER SMOOTHLY INTO THE PATIENT. THE CATHETER WAS WITHDRAWN, AND THE CATHETER HAD A CREASE AND WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15015778 ↗
• MalfunctionApr 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. A 3.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS RETURNED WITHOUT ANY REPORTED ISSUE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED LONGITUDINAL BALLOON TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8487591 ↗
• MalfunctionJan 31, 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 12MMX3.5MM, MODERATELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A 3.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT SEPARATED/DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8293101 ↗
• MalfunctionSep 17, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 8X3.75MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.75MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, IT WAS NOTED THAT THE SHAFT WAS FRACTURED AT 30CM FROM THE DISTAL END. 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 7883108 ↗
• MalfunctionJul 5, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 95% STENOSED, 30MM IN LENGTH TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS, MILDLY CALCIFIED AND 3.75MM IN DIAMETER PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. A 3.75MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE SHAFT WAS FRACTURED. THE DEVICE WAS REMOVED WITH THE GUIDE CATHETER 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 7663939 ↗

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