Apex™ H7493895808200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729474753), received between Feb 22, 2017 and Feb 2, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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.

• MalfunctionFeb 2, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION SLOW OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 2.00MM X 8MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER THE THIRD INFLATION, IT TOOK TIME FOR THE BALLOON TO DEFLATE; THE BALLOON WAS REMOVED IN A DEFLATED STATE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7235983 ↗
• MalfunctionDec 20, 2017Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07-DEC-2017. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 8MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED TWICE AT 6 ATMOSPHERES, THE FIRST INFLATION WAS FOR 15 SECONDS AND THE SECOND WAS FOR 39 SECONDS. HOWEVER, THE BALLOON WOULD NOT STAY INFLATED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7135298 ↗
• MalfunctionFeb 22, 2017Hole In Material; Hole In Material

  SAME CASE AS MDR ID: 2134265-2017-01111. 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 6349597 ↗

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-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
• 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