Quantum™ Maverick™ H7493808008450Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729392613), received between Apr 13, 2017 and May 18, 2023 — classified as 1 injury, 10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2023Wrong Label; Wrong Label

  IT WAS REPORTED, THAT IMPROPER LABELING OCCURRED. A 4.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USED. HOWEVER, DURING UNPACKING OF THE DEVICE, IT WAS FOUND, THAT THE INTERNAL PACKAGE SHOWED DIFFERENT SIZE TO THE EXTERNAL PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16957578 ↗
• MalfunctionNov 13, 2020Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION, THE BALLOON FAILED TO INFLATE AND A PINHOLE WAS NOTED ON THE BALLOON MATERIAL. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10840170 ↗
• MalfunctionSep 22, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY. A 4.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS USED; HOWEVER, IT WAS NOTED THAT THE DEVICE BROKE INTO TWO PIECES. 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 10568007 ↗
• MalfunctionSep 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED, 4X28MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10525841 ↗
• InjuryMay 7, 2020Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL TAMPONADE OCCURRED. DURING A PROCEDURE INVOLVING A 4.5MM X 8MM QUANTUM MAVERICK BALLOON CATHETER, PERICARDIAL TAMPONADE OCCURRED. THE PROCEDURE WAS NOT COMPLETED.

  Patient problems: Cardiac Tamponade

  MAUDE report 10034663 ↗
• MalfunctionJun 7, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14MAY2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESIONS WERE LOCATED IN THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY AND LEFT ANTERIOR DESCENDING ARTERY. A 4.5MM 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 SHAFT SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8678876 ↗
• MalfunctionMay 29, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-MAY-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED, 10X4.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.5MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED; HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE TARGET 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 THE SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7549947 ↗
• MalfunctionJan 18, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A CORONARY ARTERY. DURING UNPACKING OF A 4.5MM X8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER, IT WAS NOTED THAT THE DEVICE DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7204313 ↗
• MalfunctionDec 11, 2017Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRODUCT WAS NOT STERILE. DURING UNPACKING OF A 4.5MMX8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER, IT WAS NOTED THAT THE STERILE PACKAGING OF BALLOON WAS ALREADY OPENED HOWEVER; THE OUTSIDE BOX WAS SEALED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH THE SAME DEVICE. THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7107157 ↗
• MalfunctionNov 17, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.5MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH AN NC EMERGE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7040666 ↗
• MalfunctionApr 13, 2017Break; Break

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6491005 ↗

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