Maverick²™ H7493892812250Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729369981), received between Apr 12, 2017 and Dec 15, 2024 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50 MM X 12 MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED, AND THE BALLOON CATHETER DID NOT BREAK INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20935426 ↗
• MalfunctionAug 17, 2022Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND MODERATELY CALCIFIED OBTUSE MARGINAL ARTERY. A 2.50MM X 12MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED AND THE SHAFT WAS BROKEN 10-15 CENTIMETERS FROM THE HUB. THE DEVICE WAS PULLED INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241405 ↗
• MalfunctionJun 13, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN, AND A PERCUTANEOUS CORONARY ANGIOPLASTY WAS PERFORMED ON THE RIGHT CORONARY ARTERY (RCA). A 2.50MM X 12MM MAVERICK BALLOON WAS SELECTED FOR TREATMENT, BUT AN ACCIDENTAL BREAKAGE AT THE JUNCTION OF THE BALLOON HYPOTUBE AND SHAFT OCCURRED. THE FRACTURED BALLOON WAS INSIDE THE GUIDE CATHETER, WHICH WAS INSIDE THE PATIENT. THE BALLOON DEVICE WAS REMOVED TOGETHER WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT, AND THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14680852 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED, 24X2.50MM, CONCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PREDILATATION. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE SHAFT OF THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662246 ↗
• InjuryOct 7, 2021Break; Entrapment of Device; Difficult to Remove; Break; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT A SHAFT DETACHMENT OCCURRED. THIS 2.50MM X 12MM MAVERICK BALLOON CATHETER WAS SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION. DURING REMOVAL FROM THE LESION DIFFICULTIES WERE ENCOUNTERED AND THE DISTAL END OF THE BALLOON BECAME STUCK INSIDE THE GUIDE CATHETER AND BROKE. IF WAS NOTED THAT THE BALLOON WAS DEFLATED PRIOR TO REMOVAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591886 ↗
• MalfunctionNov 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION UNDER NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10912792 ↗
• MalfunctionJun 23, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE DE NOVO TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED; HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE. THE DEVICE WAS SIMPLY REMOVED AS A WHOLE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184613 ↗
• MalfunctionJun 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.50MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION, BUT FAILED TO CROSS THE LESION DUE TO SEVERE CALCIFICATION. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10112970 ↗
• InjuryApr 30, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUES AND ELECTROCARDIOGRAM (ECG) ELEVATIONS OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LESS CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 2.50MM X 12MM MAVERICK BALLOON WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED. IT WAS NOTED THAT INFLATION WAS ALREADY "JERKY" AND THE BALLOON OPENED SUDDENLY AT 14 BAR. WHEN ATTEMPTING TO DEFLATE THE BALLOON, IT WAS NOT POSSIBLE. AS THE PROXIMAL LAD WAS CLOSED, ELEVATIONS WERE NOTED IN THE ECG. THE PROXIMAL END OF THE BALLOON CATHETER WAS THEN CUT AND A GUIDELINER WAS ADVANCED TO AID IN DEFLATING THE BALLOON. WITH THE HELP OF THE GUIDELINER, THE BALLOON COULD BE PARTIALLY DEFLATED. THE MAVERICK BALLOON AND GUIDELINER WERE THEN WITHDRAWN TOGETHER INTO A NON BSC GUIDE CATHETER AND OUT OF THE VESSEL. THE PROXIMAL LAD HAD BEEN CLOSED FOR TWO TO THREE MINUTES. UPON REMOVAL OF THE DEVICES, THE PATIENT'S CONDITION BECAME STABLE AGAIN AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Cardiac Enzyme Elevation

  MAUDE report 10013203 ↗
• MalfunctionDec 3, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13NOV2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES AND SHAFT KINK WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE CONCENTRIC TARGET LESION WITH A BEND OF >= 90 DEGREES WAS LOCATED IN THE MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. A 2.50MM X 12MM MAVERICK 2 BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, IT FAILED TO CROSS THE LESION AND AN ACUTE KINKED WAS NOTED WITH THE BALLOON SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON WITH THE SUPPORT OF GUIDEZILLA. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404474 ↗
• MalfunctionJun 14, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.50MMX12MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED INTACT FROM THE PATIENT'S BODY AND WAS REMOVED BY THE PHYSICIAN DIRECTLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701179 ↗
• MalfunctionFeb 20, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED, 20MM X 3.5MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT 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 Consequences Or Impact To Patient

  MAUDE report 8356587 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS REPORTED THE SHAFT BROKE. A 2.50MM X 12MM MAVERICK 2 MR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO PUSH THE BALLOON INSIDE THE GUIDE CATHETER, THE MID SECTION OF THE HYPOTUBE BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8258626 ↗
• MalfunctionDec 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION AS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE FIRST DILATION WAS DONE AT 10 ATMOSPHERES AND THE SECOND DILATION WAS DONE AT 12 ATMOSPHERES. HOWEVER, UPON THE THIRD INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED WITHOUT ANY ISSUES 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 8169308 ↗
• MalfunctionOct 24, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-OCT-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 32 X 4MM, DE NOVO TARGET LESION WAS LOCATED IN THE TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. SUBSEQUENTLY, PRE-DILATATION WAS PERFORMED WITH A NON-BSC BALLOON CATHETER FOLLOWED BY STENTING AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE BALLOON WAS TORN CIRCUMFERENTIALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7998464 ↗
• MalfunctionFeb 21, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26-JAN-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED, 12 X 2.5MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM MAVERICK²¿ 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 HOLE/PERFORATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286162 ↗
• MalfunctionOct 24, 2017Kinked; Kinked

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 04-OCT-2017. IT WAS REPORTED THAT SHAFT KINK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 24X3.0MM, DE NOVO TARGET LESION WAS LOCATED IN THE NONE TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. A 2.50MM X 12MM MAVERICK²¿ BALLOON CATHETER ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN LONGITUDINALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6975070 ↗
• MalfunctionAug 21, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED, 12X2.0MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 12MM MAVERICK2 BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, 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 6808081 ↗
• MalfunctionJun 1, 2017Failure to Advance; Failure to Advance

  SAME CASE AS MDR ID: 2134265-2017-05281 REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER A NON-BSC GUIDE WIRE WAS PLACED IN THE LESION, A 2.50MM X 12MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND ANOTHER 2.50MM X 12MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED BUT ALSO FAILED TO CROSS. 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 HYPOTUBE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6604212 ↗
• MalfunctionJun 1, 2017Failure to Advance; Failure to Advance

  SAME CASE AS MDR ID: 2134265-2017-05282. REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12MAY2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER A NON-BSC GUIDE WIRE WAS PLACED IN THE LESION, A 2.50 MM X 12 MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND ANOTHER 2.50 MM X 12 MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED BUT ALSO FAILED TO CROSS. 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 HYPOTUBE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6604200 ↗
• MalfunctionApr 12, 2017Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30-MAR-2017. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50MM X 12MM MAVERICK²¿ BALLOON CATHETER WAS ADVANCED BUT THE BALLOON WAS DAMAGED WHILE CROSSING THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6488840 ↗

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