Maverick²™ H7493892820250Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 08714729370185), received between Nov 15, 2016 and Jul 27, 2026 — classified as 4 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (38 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 79 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Material Rupture

  It was reported that a device issue occurred resulting in patient complications.The occluded target lesion was located in the left anterior descending artery (LAD). A non-Boston Scientific (BSC) guidewire successfully crossed the occluded segment and reached the distal vessel. A 2.50mm x 20mm Maverick balloon catheter was advanced from the proximal to the distal LAD. Repeat angiography showed no flow through the mid-segment. Pre-dilatation was then performed at 12 atmospheres. Repeat angiography demonstrated a thin thread of blood flow through the occluded segment with significant thrombus burden. There was an indication for intracoronary thrombolysis. The balloon was intentionally ruptured and advanced to the proximal end of the thrombus. A total of 20 mg of pro-urokinase was administered through the punctured balloon. Repeat angiography demonstrated reduced thrombus burden with subtotal occlusion and TIMI 1 flow in the distal segment. Significant thrombus burden remained following repeat angiography. A thrombus aspiration catheter was advanced to the proximal end of the thrombus. Continuous negative pressure aspiration was initiated while slowly advancing the catheter to the mid-

  Patient problems: Foreign Body In Patient; Reduced Blood Flow; Thrombosis/Thrombus

  MAUDE report 50009735 ↗
• MalfunctionJan 14, 2026Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM MAVERICK. BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. 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 24071424 ↗
• MalfunctionJan 5, 2026Material 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 (LAD). A 2.50MM X 20MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. 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 23966959 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT HAD SUFFERED WITH AN ACUTE MYOCARDIAL INFARCTION AND UNDERWENT AN EMERGENCY PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED TO PRE-DILATE THE LESION. DURING THE PROCEDURE, WHEN THE BALLOON WAS REMOVED FROM THE PATIENT, THE CATHETER FRACTURED. THE CATHETER WAS THEN SLOWLY WITHDRAWN FROM THE PATIENT'S BODY THROUGH A NON-BOSTON SCIENTIFIC SHEATH, AND NO HARM WAS CAUSED TO THE PATIENT. THE BALLOON WAS REPLACED WITH A NEW TRANSLUMINAL CORONARY ANGIOPLASTY BALLOON, AND THE PROCEDURE WAS COMPLETED. THE PATIENT REMAINED STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017472 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.50 MM X 20 MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE DEVICE WAS FRACTURED WHEN IT WAS TAKEN OUT DUE TO SLIGHT BENDING IN THE PUSHING PROCESS. 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 22984732 ↗
• MalfunctionJun 23, 2025Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE CORONARY ANGIOGRAPHY OF THE PATIENT SHOWED 95% TUBULAR STENOSIS OF THE RIGHT CORONARY ARTERY. A 2.50MM X 20MM MAVERICK BALLOON CATHETER WAS SELECTED TO PRE-DILATE THE LESION. HOWEVER, AFTER OPENING ITS INNER PACKAGING, IT WAS FOUND OUT THE SHAFT WAS BROKEN AND THE FRONT END OF THE BALLOON TIP FRACTURED. THE DEVICE WAS REPLACED IMMEDIATELY, AND THE PROCEDURE WAS COMPLETED. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309680 ↗
• MalfunctionApr 2, 2025Material Rupture; 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 2.50MM X 20MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DUE TO SEVERAL CALCIFICATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752458 ↗
• InjuryDec 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED RESULTING IN REDUCED BLOOD FLOW, CHEST PAIN, HYPOTENSION, AND BRADYCARDIA WHICH REQUIRED TREATMENT. THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50MM X 20MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON REACHED 12 ATMOSPHERES, THE BALLOON RUPTURED RESULTING IN INTERRUPTION OF BLOOD FLOW IN THE LAD. THE PATIENT EXPERIENCED CHEST PAIN, LOW BLOOD PRESSURE, AND SLOW HEART RATE. MEDICATION WAS ADMINISTERED IMMEDIATELY AND THE PATIENT SYMPTOMS IMPROVED. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: Bradycardia; Chest Pain; Low Blood Pressure/ Hypotension; Reduced Blood Flow

  MAUDE report 20995881 ↗
• MalfunctionSep 11, 2024Deflation Problem; Difficult to Remove; Failure to Deflate; Deflation Problem; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUES OCCURRED. THE TARGET LESION, WHICH WAS 100% STENOSED, WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 6F GUIDE CATHETER WAS UTILIZED AND A 2.50MM X 20MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED, WITH RESISTANCE ENCOUNTERED, TO 6 ATMOSPHERES FOR 2 SECONDS DURING THE PROCEDURE BUT EXPERIENCED POOR RETRACTION DURING DEFLATION. DESPITE EFFORTS TO DEFLATE THE BALLOON FOR 5 SECONDS, IT FAILED TO RETRACT PROPERLY, NECESSITATING THE REMOVAL OF THE ORIGINAL BALLOON. THE DEVICE WAS REMOVED ALONG THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193055 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 2.50MM X 20MM MAVERICK BALLOON CATHETER, IT WAS FOUND THAT THE DEVICE BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469981 ↗
• MalfunctionApr 18, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. UPON UNPACKING OF A 2.50MM X 20MM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE SHAFT WAS DAMAGED AND BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT RAPID EXCHANGE PART OF THE BALLOON WAS FOUND TO BE FRACTURED AFTER BEING UNPACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19137760 ↗
• MalfunctionMar 26, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11-MAR-2024. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION IS LOCATED IN THE RIGHT FEMORAL ARTERY. A 2.50MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, IT WAS FOUND THAT THE BALLOON WAS LEAKING GAS AND COULD NOT INFLATE NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983419 ↗
• MalfunctionFeb 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703090 ↗
• MalfunctionApr 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16699337 ↗
• MalfunctionDec 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE NOT TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 2.50 X 20MM MAVERICK BALLOON WAS ADVANCE FOR DILATION OF THE TARGET LESION. ON THE FIRST INFLATION, WITH MINIMAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970717 ↗
• MalfunctionDec 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-DEC-2022. IT WAS REPORTED THAT NO KNOWN DEVICE ISSUES WERE ENCOUNTERED. THE 85% STENOSED, TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50MM X 20MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, PHYSICIAN TRIED TO POST BALLOON AFTER STENTING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969061 ↗
• MalfunctionOct 7, 2022Material Rupture; Material 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 ARTERY. AFTER STENT IMPLANTATION, A 2.50MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, DURING INFLATION AT 17 ATMOSPHERES FOR 16-18 SECONDS, THE BALLOON RUPTURED. THERE WERE NO BALLOON PIECES LEFT IN THE PATIENT'S BODY AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15565430 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED TO LEFT CIRCUMFLEX (LCX) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LAD. AFTER A 7F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED AND A NON-BSC GUIDEWIRE CROSSED THE LESION, PRE-DILATION WAS PERFORMED IN LCX WITH A 2.50 X 20MM MAVERICK 2 BALLOON CATHETER. FOLLOWING PRE-DILATION, A 3.00 X 28MM SYNERGY WAS IMPLANTED AND FURTHER POST DILATED. THE SAME 2.50 X 20MM MAVERICK 2 BALLOON CATHETER WAS TRIED TO USE FOR THE LAD; HOWEVER, THE SHAFT BROKE 27 INCHES FROM THE PROXIMAL HUB OUTSIDE THE Y CONNECTOR, OUTSIDE THE PATIENT. THE DEVICE WAS SIMPLY PULLED OUT TO REMOVE IT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 2.50 X20 MM NON -BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15123058 ↗
• MalfunctionJul 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. INFLATION WAS PERFORMED TWICE AT 12 ATMOSPHERES FOR 21-22 SECONDS. HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15067902 ↗
• MalfunctionMay 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14440751 ↗
• MalfunctionMay 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES FOR 21-22 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278986 ↗
• MalfunctionApr 5, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. A 2.50MM X 20MM MAVERICK 2 MR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE DEVICE REACHED THE LESION POSITION, THE PHYSICIAN FOUND BLOOD FLOWED INTO THE BALLOON AND WAS NOTED TO BE LEAKING BEFORE IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED 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 14016428 ↗
• MalfunctionMar 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED TWICE AT 12 ATMOSPHERES RESPECTIVELY FOR 21-22 SECONDS AND 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13728166 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID CIRCUMFLEX (CX). A 2.50 X 20MM MAVERICK BALLOON, WAS ADVANCED TO THE TARGET LESION, BUT WHILE INFLATING THE BALLOON, THE DEVICE BROKE IN THREE PIECES. IT WAS NOTED THAT THE BREAK OCCURRED IN BETWEEN THE STENOSIS. THE DEVICE BROKE IN SEVERAL PIECES DURING INFLATION OF THE DEVICE. IT WAS NOTED THAT THE DEVICE BROKE WITHOUT ANY VISIBLE REASON. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PROBLEM FOR THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535711 ↗
• MalfunctionJan 24, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE MIDDLE PART OF THE SHAFT WAS CUT OFF. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13337915 ↗

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