Quantum™ Maverick™ H7493808020250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729392873), received between Dec 19, 2016 and Dec 2, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Kinked” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGE SEAL WAS BROKEN. DURING PREPARATION OF A 2.5MM X 20MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE SEAL OF THE ASEPTIC PACKAGING WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9398026 ↗
• MalfunctionMar 8, 2018Kinked; Kinked

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. IT WAS REPORTED THAT SHAFT KINK OCCURRED. DURING PREPARATION OF A 2.5MM X 20MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALS HYPOTUBE BREAK.

  Patient problems: No Patient Involvement

  MAUDE report 7325192 ↗
• MalfunctionDec 19, 2016Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5MMX20MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATION AND THE DEVICE WAS INITIALLY INFLATED AT 12 ATMOSPHERES FOR 10 SECONDS. SECOND INFLATION WAS PERFORMED AT 14 ATMOSPHERES FOR 10 SECONDS; HOWEVER, DURING THE THIRD INFLATION AT 18 ATMOSPHERES FOR 10 SECONDS, THE BALLOON DEFLATED SLOWLY BY ITSELF BEFORE DEFLATION. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6187263 ↗

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