Apex™ H7493895915200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729475590), received between Dec 20, 2016 and Jul 28, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2022Material Twisted/Bent

  EARLY 80¿S MALE WITH DIABETES AND RECENT CHEST PAIN. PROCEDURE; PERCUTANEOUS INTERVENTION PROXIMAL RIGHT CORONARY, STENT PLACEMENT AND BALLOON ANGIOPLASTY. BALLOON SHAFT KINKED AND NOT ABLE TO USE FOR PROCEDURE. REMOVED AND USED ANOTHER DEVICE WITHOUT COMPLICATIONS. NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120946 ↗
• MalfunctionOct 22, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 15MM APEX BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. THE BALLOON WAS INFLATED USING A NON-BSC INDEFLATOR WITH 50/50 OMNIPAQUE CONTRAST AT 6 ATMOSPHERES FOR 15 SECONDS. HOWEVER, THE PHYSICIAN ENCOUNTERED DIFFICULTY IN INFLATING AND DEFLATING THE BALLOON. THE BALLOON WAS THEN MANAGED TO BE FULLY DEFLATED WHEN REMOVED. THE PROCEDURE WAS COMPLETED AS PLANNED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7991885 ↗
• MalfunctionDec 21, 2017Kinked; Kinked

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2017. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.00MM X 15MM APEX¿ BALLOON CATHETER WAS ADVANCED BUT IT WAS NOTED THAT THE DEVICE DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.00MM X 15MM APEX¿ BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BROKEN SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7140914 ↗
• MalfunctionDec 20, 2016Fracture; Fracture

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 15MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INTRODUCTION, THE SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6190704 ↗

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-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