Maverick²™ H7493892815150Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 08714729370055), received between Jan 26, 2017 and Sep 17, 2026 — classified as 1 death, 2 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (54 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient died.The patient presented with 95% stenosis of the left anterior descending artery (LAD) and 90% stenosis of the right coronary artery (RCA) with high calcium and tortuosity of the vessel. After the bed was prepared with a 1.50 x 15 mm Maverick 2 balloon a non-Boston Scientific (non-BSC) stent was deployed and post dilated successfully. The proximal RCA was then pre-dilated with a 2.00 x 12 mm Maverick 2 balloon and another non-BSC stent was successfully deployed and post-dilated. After deployment of the second stent in the RCA, a non-BSC drug coated balloon was used at the proximal end. After completion of the procedure, the patient was stable and sent to the coronary care unit for post-procedural monitoring. During the night, the patient developed hypotension and went into cardiac arrest. Cardiopulmonary Resuscitation was immediately started and continued. Once the pressure got done and the patient did not come back, they were declared expired. An autopsy was not performed.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 50800969 ↗
• MalfunctionMar 13, 2026Nonstandard Device; 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. A 1.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED DUE TO SEVERAL CALCIFICATION. THE PROCEDURE WAS COMPLETED 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 24595854 ↗
• MalfunctionMar 4, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST DUE TO SEVERE CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508054 ↗
• MalfunctionMar 3, 2026Nonstandard Device; 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. A 1.50MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED POST PROCEDURE, AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498127 ↗
• MalfunctionMar 2, 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 ARTERY. A 1.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481048 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED CARDIOPULMONARY ARREST (CPA) POST PROCEDURE. DURING A PULSE FIELD ABLATION PROCEDURE, A VERSACROSS RF WIRE, A FARAWAVE NAV CATHETER, AND A 1.50MM X 15MM MAVERICK 2 BALLOON CATHETER WERE SELECTED FOR USE. THE PROCEDURE WAS COMPLETED. APPROXIMATELY TWO HOURS AFTER RETURNING TO THE ROOM, THE PATIENT EXPERIENCED CPA. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INSERTED. THE PATIENT'S CIRCULATORY DYNAMICS WERE STABLE, BUT BRAIN FUNCTION WILL BE MONITORED FOR FURTHER OBSERVATION. THE EFFECT OF ROCURONIUM WAS CONSIDERED, BUT THE ANESTHESIOLOGIST BELIEVED ITS IMPACT WAS MINIMAL. SINCE IT WAS AFTER PFA (PULMONARY FIBROSIS ABLATION), AND IN THIS CASE, THE NUMBER OF PFAS (67 TIMES) WAS HIGHER THAN USUAL, THE CAUSE COULD NOT BE RULED OUT, BUT THE EXACT CAUSE WAS UNKNOWN.

  Patient problems: Cardiac Arrest

  MAUDE report 24125836 ↗
• MalfunctionDec 19, 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 1.50MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853517 ↗
• MalfunctionNov 17, 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 1.50MM X 15MM MAVERICK 2 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 23568091 ↗
• MalfunctionNov 13, 2025Nonstandard Device; Material Rupture; Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM X 15MM MAVERICK? BALLOON CATHETER. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS IN GOOD CONDITION. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ADVANCED FOR DILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547543 ↗
• MalfunctionNov 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. ON (B)(6) 2025, A PATIENT UNDERWENT CORONARY ANGIOGRAPHY AND STENT IMPLANTATION. AT APPROXIMATELY 10:40 AM, BALLOON DILATION WAS BEING PERFORMED USING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). A 1.50MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTICED THAT THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED. SUBSEQUENTLY, ANOTHER DEVICE WAS USE AND THE PROCEDURE WAS RESUMED AROUND 11:00 AM. THE REMAINDER OF THE PROCEDURE WAS CARRIED OUT WITHOUT INCIDENT. THE RUPTURE OF THE BALLOON DURING THE PROCEDURE RESULTED IN AN EXTENSION OF THE PROCEDURE TIME BY NEARLY 20 MINUTES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498013 ↗
• MalfunctionAug 4, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 22702136 ↗
• InjuryJun 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED RESULTING IN CORONARY DISSECTION. THE PATIENT UNDERWENT A CORONARY INTERVENTION PROCEDURE DURING WHICH A CALCIFIED CORONARY LESION WITH SHARP NODULAR STRUCTURE WAS IDENTIFIED. PRE-DILATION WAS PERFORMED USING A 1.50 MM X 15 MM MAVERICK 2 BALLOON CATHETER. DURING THE THIRD BALLOON INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED, RESULTING IN A NON-FLOW-LIMITING TYPE C CORONARY ARTERY DISSECTION. THE PATIENT EXPERIENCED CHEST PAIN, AND IMMEDIATE PAIN RELIEF WAS PROVIDED. TO MANAGE THE DISSECTION AND RESTORE CORONARY BLOOD FLOW, A NEW 1.50 MM X 15 MM BALLOON CATHETER WAS INTRODUCED AND USED FOR FURTHER DILATION OF THE LESION. FOLLOWING THIS INTERVENTION, CORONARY BLOOD FLOW WAS RESTORED, AND NO ADDITIONAL COMPLICATIONS WERE NOTED AT THE TIME OF REPORTING.

  Patient problems: Chest Pain; Vascular Dissection

  MAUDE report 22311851 ↗
• MalfunctionApr 2, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS CONFIRMED THAT AFTER OPENING THE PACKAGE, THE BALLOON WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753902 ↗
• MalfunctionMar 18, 2025Material 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 1.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED DUE TO SEVERE CALCIFICATION. 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 21636786 ↗
• MalfunctionMar 12, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. IN (B)(6) 2024, THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY AND STENT IMPLANTATION. A 1.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION, AND IT ALSO MET RESISTANCE WHEN ENTERING THE BLOOD VESSEL. HOWEVER, DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS WITHDRAWN, THE BALLOON CATHETER DELIVERY SHAFT FRACTURED. 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 21589353 ↗
• MalfunctionSep 18, 2024Material 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. A 1.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THIRD INFLATION AT NOMINAL PRESSURE FOR 15 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246181 ↗
• MalfunctionAug 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 1.50MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990271 ↗
• MalfunctionApr 25, 2024Material 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 RIGHT CORONARY ARTERY. A 1.50MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED BEFORE PASSING THROUGH THE LESION. 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 19187910 ↗
• MalfunctionApr 19, 2024Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATION, A 1.50MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE FAILED TO TRACK THE LESION AND WHILE THE BALLOON WAS INFLATED AT NOMINAL ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 19147136 ↗
• MalfunctionMar 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 1.50MM X 15MM FG MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION TOGETHER WITH THE 6FR GUIDE CATHETER AND 0.014 GUIDE CATHETER AS PART OF THE PREPARATION OF THE VESSEL. HOWEVER, IT WAS FOUND THAT THE BALLOON WAS RUPTURED AND DOES NOT REACH 4 ATMOSPHERES WHILE TRYING TO INFLATE WITH THE INSUFFLATOR SYRINGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937296 ↗
• MalfunctionMar 11, 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 1.5MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875768 ↗
• MalfunctionMar 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.50MM X 15MM 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 COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852020 ↗
• MalfunctionMar 4, 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 1.50MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS SEVERELY TORTUOUS WITH 90% STENOSIS. IT WAS NOTED THAT THE BALLOON RUPTURED DURING THE FIFTH INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832509 ↗
• MalfunctionFeb 29, 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 1.50MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, 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 POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808330 ↗
• MalfunctionFeb 22, 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 1.50MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18763880 ↗

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