Quantum™ Maverick™ H7493808012200Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729392637), received between Dec 12, 2018 and May 7, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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.

• MalfunctionMay 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL END OF LEFT ANTERIOR DESCENDING ARTERY. A 2.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION UPON REACHING THE RATED BURST PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795082 ↗
• MalfunctionNov 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 35% STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION UNDER NOMINAL PRESSURE FOR A FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS SIMPLY REMOVED AND 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 Consequences Or Impact To Patient

  MAUDE report 10912805 ↗
• MalfunctionSep 12, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20AUG2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 2.0MM X 12MM QUANTUM MAVERICK BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT WAS KINKED. 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 9005731 ↗
• MalfunctionFeb 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90% STENOSED, CONCENTRIC AND THE DE NOVO TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. AFTER A JR 3.5 NON-BSC GUIDE CATHETER WAS ENGAGED AND A NON-BSC GUIDE WIRE CROSSED THE LESION. A 2.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION; HOWEVER, UPON INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8334023 ↗
• MalfunctionDec 12, 2018Inflation Problem; Inflation Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 20-NOV-2018. IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE CONCENTRIC TARGET LESION CONTAINED A BEND >=90 DEGREES AND WAS LOCATED IN THE MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY. A 2.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON FAILED TO INFLATED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON WITH BUDDY WIRE SUPPORT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHMENT. DEVICE EVALUATED BY MANUFACTURER: THE RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER. THE SHAFT, HYPOTUBE, TIP AND BALLOON WERE MICROSCOPICALLY AND VISUALLY EXAMINED. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE NUMEROUS HYPOTUBE KINKS THROUGHOUT THE DEVICE. THERE WAS A COMPLETE HYPOTUBE SEPARATION 19.2CM DISTAL OF THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. FUNCTIONAL TESTING WAS PERFORMED BY ATTACHING INFLATION DEVICE FILLED WATER TO THE REMAINING DISTAL END OF THE DEVICE BY ATTACHING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156243 ↗

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-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