Quantum™ Maverick™ H7493808012300Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 08714729392675), received between Dec 4, 2016 and Sep 17, 2026 — classified as 4 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Break” (47 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 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Rupture; Failure to Deflate

  It was reported that a balloon rupture occurred.A 3.00 mm x 12 mm Quantum Maverick was selected for use. The balloon was advanced to the target lesion and inflated once at 12 ATM for 5 to 10 seconds. During inflation, the balloon ruptured, resulting in improper deflation of the device. The device was successfully removed from the patient, and the procedure was completed with another same device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800566 ↗
• MalfunctionApr 2, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING INFLATION, A LEAK WITHOUT ANY VISIBLE PINHOLES WAS DETECTED AND UPON INSPECTION, THE BALLOON DELIVERY SHAFT WAS NOTED TO BE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766872 ↗
• InjuryDec 24, 2025Break; Nonstandard Device; Difficult to Advance; Break; Nonstandard Device; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PREVIOUSLY UNDERWENT DUAL STENTING ON THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE LEFT CIRCUMFLEX ARTERY (LCX). DUE TO SUSPICIONS THAT THE LCX STENT MIGHT NOT HAVE BEEN OPTIMALLY DEPLOYED AND THE PATIENT'S RECURRENT SYMPTOMS, A DECISION WAS MADE TO PROCEED WITH A REPEAT SURGICAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LCX. THE PHYSICIAN INITIALLY ATTEMPTED TO IMPLANT AN ADDITIONAL STENT IN THE LCX. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS PRE-POSITIONED IN THE LAD. THE STENT WAS THREADED THROUGH A NON-BOSTON SCIENTIFIC IMPLANTED STENT IN LAD TOWARD THE LCX BUT WAS UNSUCCESSFUL. THE BALLOON WAS THEN WITHDRAWN, AND THE PHYSICIAN OPTED TO PLACE A STENT FROM THE LAD TO THE LEFT MAIN ARTERY. POST-DEPLOYMENT, A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS USED FOR POST-DILATATION; HOWEVER, DURING ADVANCING, RESISTANCE WAS ENCOUNTERED. THE BALLOON WAS REMOVED USING A 2.0MM BALLOON TO ANCHOR THE QUANTUM MAVERICK WITHIN THE GUIDING CATHETER. UPON INSPECTION, THE DISTAL END OF THE BALLOON'S DELIVERY SHAFT WAS FOUND TO B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889601 ↗
• MalfunctionDec 15, 2025Break; Difficult to Advance; Human-Device Interface Problem; Break; Difficult to Advance; Human-Device Interface Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 3.00 X 12 MM QUANTUM? MAVERICK? BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A HIGHLY RESISTANT, 90% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. WITH THE ASSISTANCE OF A GUIDE EXTENSION CATHETER, THE BALLOON WAS ADVANCED WITH SIGNIFICANT RESISTANCE TO THE AREA WHERE A PREVIOUSLY POSITIONED NON-BOSTON SCIENTIFIC SENT WAS POORLY APPOSED. AFTER SEVERAL DILATIONS, THE DELIVERY SHAFT WAS NOTED TO BE BROKEN WITHIN THE GUIDE CATHETER. ANCHORING WITH A 2.00 MM NON-COMPLIANT BALLOON WAS NECESSARY IN ORDER TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23807126 ↗
• MalfunctionJan 1, 2024Break; Break

  IT WAS REPORTED SHAFT BREAK OCCURRED. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE DEVICE FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423243 ↗
• InjuryJul 18, 2023Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE 70% STENOSED, 60MMX2.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON SHAFT FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON SHAFT FRACTURED A THIRD OF THE WAY FROM THE HUB DURING DELIVERY INTO THE BODY, THE DEVICE WAS REMOVED FROM THE PATIENT WITH A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17346972 ↗
• MalfunctionJan 18, 2023Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT THE STERILE PACKAGE OF THE BALLOON WAS BROKEN AND COULD NOT BE USED. THE DEVICE WAS REPLACED IMMEDIATELY WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196095 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE DEVICE WAS SEPARATED INTO TWO PIECES. THE DEVICE WAS NEVER USED AND WAS REPLACED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14620341 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. 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 13447800 ↗
• MalfunctionJan 5, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ATHEROSCLEROTIC ANGINA PECTORIS. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, 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 13169990 ↗
• InjuryNov 13, 2021Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT MAIN ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED AND THE SHAFT WAS SEPARATED IN TWO PIECES 80 CENTIMETERS FROM THE HUB. THE DEVICE WAS REMOVED BY SNARING AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808170 ↗
• MalfunctionJun 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY TO MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 12 ATMOSPHERES FOR 20 SECONDS, 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 12065332 ↗
• MalfunctionJun 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE FRONT TIP OF THE DEVICE WAS FRACTURED. THE FRACTURED PART WAS REMOVED MANUALLY, NO INTERVENTION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971309 ↗
• MalfunctionFeb 17, 2021Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30JAN2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT CORONARY ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, THE SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340374 ↗
• MalfunctionFeb 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% IN-STENT RESTENOSED TARGET LEISON WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED FROM LOW PRESSURE AND EVERY 5 SECONDS, IT WAS INCREASED AT 1 ATMOSPHERE PRESSURE. HOWEVER, WHEN PRESSURE WAS AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310948 ↗
• MalfunctionFeb 4, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28JAN2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CORONARY ARTERY (LCA). A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE DELIVERY SHAFT WAS KINKED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278430 ↗
• MalfunctionJan 11, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE DEVICE WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED BY JUST SIMPLY PULLING IT OUT AND 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11147215 ↗
• MalfunctionJan 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL END OF THE LEFT ANTERIOR DESCENDING ARTERY. AFTER A 3.5 NON-BOSTON SCIENTIFIC (BSC) SHEATH WAS PLACED IN THE OSTIUM OF THE LEFT CORONARY ARTERY (LCA) AND A NON-BSC GUIDEWIRE CROSSED THE LESION, A 2.5-20 NON-BSC BALLOON CATHETER WAS ADVANCED FOR PREDILATATION AND WAS FOLLOWED BY IMPLANTATION OF A 3.0-24 NON-BSC STENT. SUBSEQUENTLY, A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING INITIAL INFLATION, THE BALLOON RUPTURED. POST-DILATATION WAS PERFORMED WITH ANOTHER OF THE SAME DEVICE AND THE STENT WAS WELL APPOSED TO THE VESSEL. TIMI 3 FLOW WAS ESTABLISHED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11146874 ↗
• MalfunctionJan 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL END OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER A NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ADVANCED TO THE OSTIAL OF THE LAD AND A NON-BSC GUIDEWIRE CROSSED AND WAS POSITIONED IN THE DISTAL END, PRE-DILATION WAS PERFORMED WITH 2.5X20 NON-BSC BALLOON CATHETER UNDER 6 ATMOSPHERES. FOLLOWING PRE-DILATION, A 3.0X24 NON-BSC STENT WAS IMPLANTED TO TREAT THE LESION. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST-DILATION; HOWEVER, DURING INITIAL INFLATION, THE BALLOON RUPTURED. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11146867 ↗
• MalfunctionDec 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. AFTER ADVANCING A 5F NON-BOSTON SCIENTIFIC IMAGING CATHETER, A COMPLETE OCCLUDED LESION WAS NOTED IN THE OSTIAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING FIRST INFLATION AT 13 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHIN THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10998930 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. WHEN A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS UNPACKED, IT WAS NOTED THAT THE DEVICE WAS FRACTURED INTO TWO PIECES. THE DEVICE NEVER ENTERED INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10776061 ↗
• MalfunctionSep 22, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE IT WAS NOTED THAT THE CATHETER WAS FRACTURED. THE DEVICE WAS SIMPLY PULLED OUT AND 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10568002 ↗
• MalfunctionSep 15, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENTS BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10534665 ↗
• MalfunctionAug 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO KNOWN PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. THE BALLOON RUPTURED DURING THIRD INFLATION AT 12 ATMOSPHERES FOR 5 SECONDS. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10475016 ↗
• MalfunctionAug 20, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. 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 10431183 ↗

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-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