Quantum™ Maverick™ H7493808008320Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729392576), received between Nov 21, 2016 and Aug 31, 2020 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 75% STENOSED, 30MMX3.5MM TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.25MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE THE DELIVERY SHAFT WAS FRACTURED AT 15CM AWAY FROM THE DISTAL END OF THE BALLOON. THE DEVICE WAS SIMPLY PULLED OUT AND NOTHING WAS LEFT INSIDE THE PATIENT'S BODY. 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 10472116 ↗
• MalfunctionMay 14, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 3.25MMX8MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTICED THAT THE DELIVERY SHAFT WAS FRACTURED. NO PATIENT COMPLICATIONS REPORTED AS THE DEVICE DID NOT ENTER THE PATIENT'S BODY.

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

  MAUDE report 8608559 ↗
• MalfunctionJun 6, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 3.25MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER, IT WAS NOTED THAT THE SHAFT WAS KINKED AND WAS TOTALLY BROKEN DURING REPACKAGE. 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 Patient Involvement

  MAUDE report 7575990 ↗
• MalfunctionJul 12, 2017Kinked; Kinked

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2017. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.25MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE SHAFT GOT KINKED WHEN THE DEVICE REACHED 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 6707351 ↗
• MalfunctionMay 18, 2017Failure to Advance; Failure to Advance

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS INTACT WHEN REMOVED FROM THE PATIENT AND WHEN PACKED FOR RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6577492 ↗
• MalfunctionMay 15, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-MAY-2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED.   THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.25MM X 8MM 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 A HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6567632 ↗
• MalfunctionNov 21, 2016Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-NOV-2016. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.25MM X 8MM QUANTUM¿ MAVERICK¿ WAS ADVANCED BUT FAILED TO CROSS THE LESION. 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. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE HYPOTUBE BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6119589 ↗

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