Apex™ H7493895940200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729475910), received between Dec 19, 2016 and May 1, 2019 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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.

• MalfunctionMay 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT LOADING DIFFICULTIES WERE ENCOUNTERED. A 2.00MM X 40MM APEX BALLOON CATHETER WAS SELECTED FOR USE TO DILATE THE LESION. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO BE LOADED ONTO THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PROLAPSE AND HOLE IN GUIDEWIRE LUMEN AND PUNCTURE MARK IN THE INFLATION LUMEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569982 ↗
• DeathMar 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID #: 2134265-2018-02589, 2134265-2018-02590, 2134265-2018-02591, 2134265-2018-02592, 2134265-2018-02593, 2134265-2018-02628, 2134265-2018-03162, 2134265-2018-03163, 2134265-2018-03164, 2134265-2018-03165, 2134265-2018-03166, 2134265-2018-03167, 2134265-2018-03168, 2134265-2018-03169, 2134265-2018-03173. IT WAS REPORTED THAT THE PATIENT DIED POST PROCEDURE. THE PATIENT PRESENTED FROM HOSPICE CARE. THE PATIENT WAS INTUBATED AND HAD A NON-BSC HEART PUMP IN PLACE. THE TARGET LESIONS WERE A CHRONIC TOTAL OCCLUSION OF THE RIGHT CORONARY ARTERY (RCA), THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE SEVERELY TORTUOUS CIRCUMFLEX. SEVENTEEN BOSTON SCIENTIFIC PRODUCTS WERE USED THROUGHOUT THE PROCEDURE. THE PHYSICIAN STARTED WITH THE CIRCUMFLEX AND EXPERIENCED A VESSEL PERFORATION CAUSED BY A NON-BSC GUIDEWIRE. THE PERFORATION WAS MINIMAL AND WAS NOT TREATED. THE LAD AND LEFT MAIN ARTERIES WERE SUCCESSFULLY STENTED WITH 2.50X38MM, 3.00X38MM AND 3.50X16MM SYNERGY STENTS AND BALLOON ANGIOPLASTY WAS PERFORMED. AT THAT POINT, THE PATIENT¿S PRESSURE AND HEART RATE WERE BOTH DROPPING. THE HEART RATE WAS INCREASED WITH PACING AND THE PROCEDURE WAS ENDED. THE PATIENT WAS SENT FROM

  Patient problems: Cardiogenic Shock; Death

  MAUDE report 7383150 ↗
• MalfunctionFeb 8, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. A 2.00MM X 40MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON WAS OVERINFLATED WHICH CAUSED THE INNER HYPOTUBE TO FUSE WITH THE NON-BSC GUIDE WIRE AND BECAME STUCK. THE BALLOON CATHETER AND GUIDE WIRE WERE THEN REMOVED TOGETHER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6311901 ↗
• InjuryDec 19, 2016Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND VESSEL PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTERIOR DESCENDING ARTERY (PDA). A 2.00MM X 40MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. A PERFORATION ON THE ARTERY WAS THEN NOTED AND A STENT WAS DEPLOYED TO COVER THE PERFORATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 6185163 ↗

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