Quantum™ Maverick™ H7493808015250Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08714729392767), received between Jan 17, 2017 and Sep 16, 2025 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Nonstandard Device; Material Rupture; Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065939 ↗
• MalfunctionJul 3, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH ACUTE ANTERIOR WALL MYOCARDIAL INFARCTION. A CORONARY ANGIOGRAM SHOWED CORONARY ARTERY DISEASE WITH TRIPLE VESSEL DISEASE. THE PROCEDURES WERE PERFORMED ON LEFT ANTERIOR DESCENDING (LAD) AND RIGHT CORONARY ARTERIES (RCA). DURING TREATMENT OF 70% STENOSED, MODERATELY TORTUOUS AND NON-CALCIFIED RCA, A 2.5MM X 15MM QUANTUM? MAVERICK? BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, THE SHAFT BENT AND EVENTUALLY FRACTURED. THE DEVICE WAS THEN REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394291 ↗
• MalfunctionMay 2, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED MID-TO-DISTAL SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, AFTER OPENING THE PACKAGE AND PULLING OUT THE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY EXPANSION CATHETER, IT WAS NOTICED THAT THE DELIVERY CATHETER WAS FRACTURED AT 56CM FROM THE HUB. THE DEVICE WAS IMMEDIATELY REPLACED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229466 ↗
• MalfunctionMay 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS INITIALLY INFLATED AT 10 ATMOSPHERES BUT RUPTURED ON THE SECOND INFLATION AT 12 ATMOSPHERES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19223010 ↗
• MalfunctionNov 14, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 15MM FG QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT WAS KINKED AND WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130192 ↗
• MalfunctionApr 10, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY HEART DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS FRACTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709565 ↗
• MalfunctionAug 25, 2022Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE OCCLUDED TARGET LESION WAS LOCATED IN THE MIDDLE OF LEFT CIRCUMFLEX. DURING PREPARATION OF A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER, THE DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294254 ↗
• MalfunctionJul 27, 2022Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-JUL 2022. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 95% STENOSED AND 28MM IN LENGTH TARGET LESION WAS LOCATED IN THE 3.0MM IN DIAMETER, SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DELIVERY SHAFT WAS KINKED APPROXIMATELY 50CM FROM THE HUB. THE DEVICE WAS SIMPLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHMENT/SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15116618 ↗
• MalfunctionJun 2, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NONE CALCIFIED AND NON TORTUOUS MID OF LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING STENT IMPLANTATION, A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING EXPANSION THE PHYSICIAN FOUND THE FRONT END OF THE CATHETER WAS BROKEN, 40 CM FROM THE HUB BUT NOT COMPLETELY FRACTURED. THE DEVICE WAS COMPLETELY REMOVED IN A NORMAL MANNER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925803 ↗
• MalfunctionMay 14, 2021Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23APR2021. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT COULD NOT BE DILATED AFTER RETRACTING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829389 ↗
• MalfunctionDec 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT MAIN AND LEFT ANTERIOR DESCENDING ARTERY (LAD). A NON-BOSTON SCIENTIFIC STENT WAS ADVANCED BUT COULD NOT REACH THE LESION. AFTER REMOVING THE STENT, A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED ALONG WITH A GUIDEWIRE IN THE PROXIMAL END OF LAD. HOWEVER, DURING THIRD DILATATION AT 18 ATMOSPHERES, THE BALLOON BURST. THE DEVICE WAS REMOVED WITHIN THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10998924 ↗
• MalfunctionNov 25, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-NOV-2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING PROCEDURE, THE BALLOON DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10907057 ↗
• MalfunctionNov 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE WAS ENCOUNTERED. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, A BALLOON PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10837070 ↗
• MalfunctionNov 2, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL WAS INCORRECT. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT THE DEVICE MODEL WAS INCORRECT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE STENT WAS SHORTER THAN THE ESTIMATED LESION.

  Patient problems: No Patient Involvement

  MAUDE report 10774257 ↗
• MalfunctionAug 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION; HOWEVER, DURING INFLATION AT 16 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 STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10464424 ↗
• MalfunctionNov 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING INTRODUCTION, IT WAS NOTED THE DISTAL TIP OF THE DEVICE WAS FRACTURED. THE DEVICE WAS COMPLETELY 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 Patient Involvement

  MAUDE report 9343399 ↗
• MalfunctionSep 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED, 22-26 MM X 2.5 - 2.75 MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.5 MM X 15 MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THERE WERE NO FRACTURED PARTS REMAINED IN 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 8960579 ↗
• MalfunctionJul 18, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-JUN-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 88% STENOSED TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY. A .5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION HOWEVER THE STENT WAS NOT ABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8805361 ↗
• MalfunctionJun 13, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20-MAY-2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.5MMX 15MM QUANTUM MAVERICK BALLOON CATHETER WAS USED BUT SHAFT KINK WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695874 ↗
• MalfunctionMay 15, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 100% STENOSED, 55MM X 2.75MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE TIP OF THE DEVICE AND THE DELIVERY SHAFT OF THE BALLOON WERE FRACTURED. 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 Consequences Or Impact To Patient

  MAUDE report 8611709 ↗
• InjuryMay 7, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 24MM X 2.75MM TAGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE DELIVERY SHAFT FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY NOR COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN USED THE SECOND BALLOON TO REMOVED THE FIRST DEVICE OUT ON THE PATIENT'S BODY TOGETHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587852 ↗
• MalfunctionDec 17, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30NOV2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO SERIOUS INJURIES NOR ADVERSE PATIENT EFFECTS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HOLES IN THE BALLOON. RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED A KINK ON THE HYPOTUBE 22CM FROM THE HUB. THERE ARE KINKS TO THE GUIDEWIRE LUMEN AT 11MM AND 13MM FROM THE TIP. MICROSCOPIC EXAMINATION REVEALED TWO PINHOLES IN THE BALLOON ON OPPOSITE SIDES AT APPROXIMATELY 9MM FROM THE TIP. THERE IS CONTRAST PRESENT IN THE INFLATION LUMEN AND BALLOON. THERE IS BLOOD IN THE GUIDEWIRE LUMEN AND THE BALLOON IS LOOSELY FOLDED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES CONTRIBUTING TO THE REPORTED CROSSING DIFFICULT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171763 ↗
• MalfunctionAug 21, 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 2.5MM X 15MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LEISON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, THE RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE BREAK AND HUB DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801320 ↗
• MalfunctionJul 10, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.5MM 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 7674012 ↗
• MalfunctionMay 24, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING THE PROCEDURE AND WHILE OUTSIDE THE PATIENT, A 2.5MM X 15MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER SHAFT FRACTURE WAS NOTED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE 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 7540063 ↗

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-0030-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
• Z-0031-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051