Maverick²™ H7493892815200Recalls & reported problems

Summary

The FDA's MAUDE database contains 203 adverse event reports that list this exact device (DI 08714729370062), received between Nov 11, 2016 and Apr 21, 2026 — classified as 1 death, 4 injuries, 198 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (107 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 203 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION AND UNDERWENT EMERGENCY CORONARY INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED PROXIMAL TO MIDDLE SEGMENT OF THE ANTERIOR DESCENDING BRANCH. A 2.00MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS, THE INFLATION PRESSURE FAILED TO RISE AND THE BALLOON RUPTURED, WHICH OCCURRED WHEN SEVERE VASCULAR CALCIFICATION WAS ENCOUNTERED. SUBSEQUENTLY, A HIGH-PRESSURE BALLOON WAS USED FOR DILATATION, AND THE TREATMENT WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941255 ↗
• MalfunctionMar 30, 2026Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. AFTER 6F EBU 3.5 NON-BOSTON SCIENTIFIC GUIDE CATHETER WAS ENGAGED, A 2.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION IN AN ATTEMPT TO REACH THE LESION. HOWEVER, HALFWAY THROUGH THE PROCEDURE, THE SHAFT OF THE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLOON DILATATION CATHETER FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 24720029 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED ON A 70% STENOSED TARGET LESION LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS USED TO ENGAGE THE VESSEL, AND A 2.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE ADVANCING THE BALLOON THROUGH THE NON-BSC GUIDE CATHETER, THE BALLOON CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 24636781 ↗
• MalfunctionMar 8, 2026Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION, A 2.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST DUE TO SEVERE CALCIFICATION. THE BALLON WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY, AND 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 24542036 ↗
• MalfunctionMar 3, 2026Material Separation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 2.00MM X 15MM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. DURING PREPARATION INSPECTION IT WAS NOTED THAT THE CATHETER TIP WAS FRACTURED. THE DEVICE WAS REPLACED AND THE PROCEDURE PROCEEDED SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24502253 ↗
• MalfunctionMar 3, 2026Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.00MM 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. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500672 ↗
• MalfunctionMar 2, 2026Nonstandard Device; Material 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 (LAD). A 2.00MM 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. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489647 ↗
• MalfunctionMar 2, 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 2.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED, AND 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 24479763 ↗
• MalfunctionMar 2, 2026Nonstandard Device; Material Rupture

  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. A 2.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED, AND 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 24479739 ↗
• MalfunctionFeb 23, 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 2.00MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED. THE DEVICE WAS SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414374 ↗
• MalfunctionFeb 13, 2026Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHILE THE PHYSICIAN TRIED TO INSERT THE DEVICE INTO THE LESION, THE BALLOON BURST DUE TO SEVERE CALCIFICATION. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337566 ↗
• MalfunctionFeb 10, 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 2.00MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND 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 24307998 ↗
• MalfunctionFeb 2, 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 2.00MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND 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 24229249 ↗
• MalfunctionJan 29, 2026Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217836 ↗
• MalfunctionJan 12, 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. A 2.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED 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 24044428 ↗
• MalfunctionDec 28, 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 LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM 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 23903867 ↗
• MalfunctionDec 22, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, DURING THE PROCEDURE, THE PUSHER ROD OF THE CATHETER FRACTURED, RESULTING IN THE INABILITY TO ADVANCE THE DEVICE. THE DEVICE WAS RETRIEVED, AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868072 ↗
• MalfunctionDec 21, 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 LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DUE TO SEVERAL CALCIFICATIONS, THE BALLOON RUPTURED. 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 23860335 ↗
• MalfunctionDec 19, 2025Nonstandard Device; Material Rupture; Nonstandard 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 2.00MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLON 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 23853449 ↗
• MalfunctionDec 9, 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 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 WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758023 ↗
• MalfunctionNov 12, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PATIENT PRESENTED WITH A 50% STENOSED TARGET LESION IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION HAD AN ANGULATION OF LESS THAN 45 DEGREES. A 2.00 MM X 15 MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, DURING PROCEDURE, THE PUSH ROD OF THE BALLOON CATHETER BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535316 ↗
• MalfunctionNov 12, 2025Material Rupture; 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 2.00MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535164 ↗
• MalfunctionNov 11, 2025Nonstandard Device; Material Rupture; Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST DUE TO SEVERE CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 23521619 ↗
• MalfunctionNov 7, 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 2.00MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATATION. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497367 ↗
• MalfunctionOct 31, 2025Nonstandard Device; Material Rupture; Nonstandard 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 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433494 ↗

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-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