Apex™ H7493895808250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729474777), received between Feb 22, 2017 and Aug 10, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 8MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INITIALLY INFLATED AT 6 ATMOSPHERES. HOWEVER, DURING THE SECOND INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6787356 ↗
• MalfunctionMay 28, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED (CTO) TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER A NON-BSC GUIDE WIRE CROSSED THE LESION, A 2.50MM X 8MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS FIRST INFLATED AT 10 ATMOSPHERES AND SECOND TO THE THIRD INFLATION AT 12 ATMOSPHERES. HOWEVER, DURING THE FOURTH INFLATION AT 12 ATMOSPHERES FOR 40 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X10MM NON-BSC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR DAMAGED REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596300 ↗
• MalfunctionFeb 22, 2017Hole In Material; Hole In Material

  SAME CASE AS MDR ID: 2134265-2017-01112. IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.00MM X 8MM AND A 2.50MM X 8MM APEX¿ BALLOON CATHETERS WERE ADVANCED FOR DILATION BUT CROSSING DIFFICULTIES WERE ENCOUNTERED. AFTER A LOT OF PUSHING, THE DEVICES WERE ABLE TO CROSS THE LESION. WHEN EACH OF THE BALLOONS WERE INFLATED, IT WAS UNABLE TO HOLD PRESSURE. WHEN THE DEVICES WERE REMOVED, A SMALL HOLE WAS NOTICED IN EACH OF THE BALLOONS. THE PHYSICIAN THEN ADVANCED A DIFFERENT BALLOON CATHETER AND DEPLOYED A STENT WHICH COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6349504 ↗

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