Apex™ Flex H7493895915150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729475583), received between Oct 16, 2019 and Oct 16, 2019 — classified as 1 injury, 1 malfunction.

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

• InjuryOct 16, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 1.50MM X 15MM APEX FLEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON SHAFT FRACTURED IN ONE OF THE VESSELS. THE BREAK WAS RIGHT ABOUT WHERE THE WIRE EXIT PORT IS. A SECOND 1.50MM X 15MM APEX FLEX BALLOON CATHETER WAS ADVANCED AND WAS USED TO REMOVE THE FRACTURED DEVICE. THE PROCEDURE WAS ENDED WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9199125 ↗
• MalfunctionOct 16, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 1.50MM X 15MM APEX FLEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION, IT WAS NOTED THAT THE SHAFT SEPARATED ABOUT 1 FOOT FROM THE DISTAL END OF THE BALLOON TIP. THE DEVICE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED AFTER STENTING. THERE WAS A DELAY IN THE PROCEDURE FOR MORE THAN HALF AN HOUR BUT NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9196197 ↗

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