Quantum™ Maverick™ H7493808015450Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729392835), received between May 17, 2018 and Nov 20, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

• InjuryNov 20, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION AND REMOVAL ISSUES OCCURRED RESULTING IN ADDITIONAL INTERVENTION. THE 70 - 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, NON-CALCIFIED RIGHT CORONARY ARTERY. FOLLOW DEPLOYMENT OF A NON-BOSTON SCIENTIFIC STENT, IT WAS NOTED THAT THE STENT DID NOT FULLY ADHERE TO THE VESSEL WALL, NECESSITATING RE-EXPANSION AND FINE-TUNING. A 4.50 MM X 15 MM QUANTUM? MAVERICK? BALLOON CATHETER WAS INTRODUCED BUT COULD NOT BE WITHDRAWN. A LARGE SYRINGE AND NEW PRESSURE PUMP WERE USED TO DEFLATE AND WITHDRAW THE BALLOON. A TRANSIENT OCCURRENCE OF CARDIAC ISCHEMIA WAS ALSO REPORTED. AFTER WITHDRAWAL, THE BALLOON STILL COULD NOT BE FULLY DEFLATED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED USING A NON-BSC POST-DILATATION BALLOON AND THE PATIENT WAS STABLE.

  Patient problems: Ischemia

  MAUDE report 23609420 ↗
• MalfunctionJan 30, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10-JAN-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED, 15MM X4.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.5MM X 15MM 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 DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289458 ↗
• MalfunctionAug 28, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-AUG-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.5MM X 15MM 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 7823543 ↗
• MalfunctionAug 20, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-AUG-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.5MM X 15MM 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 LONGITUDINAL BALLOON TEAR AND SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797659 ↗
• MalfunctionMay 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER THE SECOND INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY 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 7524575 ↗

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-0030-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
• 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