Maverick²™ H7493892820200Recalls & reported problems

Summary

The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 08714729370161), received between Nov 16, 2016 and Feb 23, 2026 — classified as 5 injuries, 156 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (97 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 161 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED DUE TO SEVERAL CALCIFICATION. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420885 ↗
• MalfunctionFeb 23, 2026Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURE DUE TO SEVERAL CALCIFICATION. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420877 ↗
• MalfunctionFeb 10, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 20MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING RETRIEVAL OF THE BALLOON, THE SHAFT MAY BE KINKED, AND THE DELIVERY ROD WAS FRACTURED INSIDE THE GUIDING CATHETER, WHICH EXTENDED THE SURGICAL TIME AND INCREASED THE SURGICAL RISK. THE NON-BOSTON SCIENTIFIC GUIDING CATHETER AND BALLOON WERE SUBSEQUENTLY WITHDRAWN TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305459 ↗
• MalfunctionJan 30, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219757 ↗
• MalfunctionJan 29, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE FIRST INFLATION AT 15 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS, AND THE PATIENT CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24216048 ↗
• MalfunctionDec 24, 2025Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.00MM X 20MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION, AND DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888793 ↗
• MalfunctionDec 4, 2025Fluid/Blood Leak; Nonstandard Device; Fluid/Blood Leak; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14NOV2025. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 25% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. UPON REACHING THE LESION SITE, THE BALLOON WAS OBSERVED TO BE LEAKING WATER FROM THE TIP OF THE DEVICE. NO VISIBLE PINHOLE WAS NOTED AT THAT TIME. THE BALLOON WAS REPLACED WITH ANOTHER OF THE SAME DEVICE, AND A STENT WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717495 ↗
• MalfunctionNov 12, 2025Nonstandard Device; Material Rupture; Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURE DUE TO SEVERAL CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532142 ↗
• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A PERCUTANEOUS INTERVENTION PROCEDURE WAS BEING PERFORMED. DURING THE PROCEDURE, A 2.00MM X 20MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, BEFORE IT WAS TRIED TO DEPLOY, THE PHYSICIAN FELT THAT THE SHAFT WAS FRACTURED. THE DEVICE WAS IMMEDIATELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784935 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE BALLOON SHAFT FRACTURED INTO TWO PIECES INTO NEARLY HALF OF THE BODY. IT WAS IDENTIFIED IMMEDIATELY, AND THE FRACTURED SEGMENT WAS FOUND OUTSIDE THE BODY. THE BALLOON REMAINED WITHIN THE CATHETER INSIDE THE PATIENT'S BODY AND HAD NOT YET REACHED THE LOCATION OF THE CORONARY ARTERY LESION. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508020 ↗
• MalfunctionJul 7, 2025Material Rupture; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Material Rupture; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.00MM X 20MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414178 ↗
• MalfunctionJan 31, 2025Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED BUT COULD NOT CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286866 ↗
• InjuryOct 10, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE INCORRECT LENGTH OF THE BALLOON OCCURRED. THE PATIENT UNDERWENT INTRAVASCULAR DILATION WITH A BALLOON DURING CORONARY ARTERY STENT IMPLANTATION. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY TO MODERATELY CALCIFIED VESSEL. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE METAL MARKER ON THE INNER WALL OF THE BALLOON MEASURED 20 MM, WHICH THE PHYSICIAN USED TO MEASURE THE LENGTH OF THE DISEASED VESSEL. BASED ON THIS MEASUREMENT, A 3.00 X 16 MM PROMUS PREMIER STENT WAS SELECTED FOR IMPLANTATION. HOWEVER, DURING IMPLANTATION OF THE STENT, IT WAS NOTED THAT THE STENT COULD NOT FULLY COVER THE LESION. UPON RELEASING AND WITHDRAWING THE STENT, IT WAS SUSPECTED THAT THE LENGTH OF THE 2.00 MM X 20MM MAVERICK BALLOON WAS SHORTER THAN 20MM. THEN, THE PHYSICIAN USED THE BALLOON WITHIN THE RELEASED 3.00 X 16 MM PROMUS PREMIER STENT TO COMPARE THE MARKERS OF A 2.00 MM X 20MM MAVERICK BALLOON, MARKERS OF A 2.00 MM X 20MM MAVERICK BALLOON AND 3.00 X 16 MM PROMUS PREMIER STENT ARE THE SAME LENGTH. THEREFORE, THE PHYSICIAN BELIEVED THAT THE 2.00 MM X 20MM MAVERICK BALLOON LENGTH WAS SHORTER THAN 20MM AND ONLY 16MM LONG.

  Patient problems: Insufficient Information

  MAUDE report 20422393 ↗
• MalfunctionSep 10, 2024Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, AFTER INSERTING THE BALLOON FOR TREATMENT ON THE LESION, THE BALLOON RUPTURED AT 6 ATMOSPHERES DURING INFLATION. THE LESION WAS SOMEWHAT CALCIFIED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.0 X 20MM MAVERICK BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183775 ↗
• MalfunctionAug 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED.THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967891 ↗
• InjuryAug 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE AND DISSECTION OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL-MID RIGHT CORONARY ARTERY. A 2.00 X 20 MM MAVERICK WAS ADVANCED FOR TREATMENT. WHEN THE CONTRAST AGENT WAS APPLIED THE BALLOON RUPTURED AND A DISSECTION WAS NOTED. THE BALLOON WAS WITHDRAWN AND THE PROCEDURE WAS COMPLETED BY PLACING A STENT. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 19963268 ↗
• InjuryJun 27, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH CORONARY HEART DISEASE AND UNDERWENT CORONARY ANGIOPLASTY. THE 90% STENOSED TARGET LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS DEFLATED, AND A LITTLE RESISTANCE WAS FELT WHEN REMOVING THE DEVICE. HOWEVER, THE DISTAL PORTION WHICH WAS 30 CENTIMETERS OF THE BALLOON THAT CONNECTS TO THE HYPOTUBE WAS DETACHED. THE FRACTURED PART OF THE DEVICE WAS TRAPPED WITH ANOTHER CORONARY BALLOON. A 2.0 X 20 EMERGE BALLOON CATHETER WAS THEN USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19627054 ↗
• MalfunctionMar 13, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT CROSSING DIFFICULTIES AND SHAFT KINK OCCURRED. THE SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION, AND THE SHAFT CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895600 ↗
• MalfunctionFeb 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED CORONARY ARTERY. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST. SUBSEQUENTLY, POST-DILATATION WAS PERFORMED WITH A 2.5 X 12 BALLOON CATHETER, AND A 2.5 X 19 PROMUS PREMIER DRUG-ELUTING STENT WAS USED, BUT A LARGE RESISTANCE WAS NOTED, AND IT FAILED TO CROSS THE LESION. AFTER WITHDRAWAL, IT WAS FOUND THAT THE SURFACE OF THE STENT WAS NOT SMOOTH AND COULD NOT BE USED NORMALLY. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18677388 ↗
• MalfunctionFeb 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE TRYING TO INSERT THE DEVICE, THE BALLOON BURST DUE TO SEVERAL CALCIFICATION. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18671090 ↗
• MalfunctionJan 3, 2024Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, DURING INFLATION AT NOMINAL ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434215 ↗
• MalfunctionJul 17, 2023Material Rupture; Failure to Advance; Difficult to Advance; Material Rupture; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.00MM X 20MM MAVERICK BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332832 ↗
• MalfunctionMay 1, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 2.00MM X 20MM MAVERICK BALLOON CATHETER, IT WAS NOTICED THAT THE CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16842973 ↗
• MalfunctionNov 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 87% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.0X20MM MAVERICK BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15718654 ↗
• MalfunctionOct 31, 2022Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED, TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.00MM X 20MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 6 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.00MM X 20MM MAVERICK BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698299 ↗

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