Apex™ H7493895915300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729475637), received between May 10, 2017 and Mar 27, 2018 — 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.

• MalfunctionMar 27, 2018Material Rupture; Material Rupture

  SAME CASE AS MDR ID: 2134265-2018-02233. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 40%- 99% STENOSED, TUBULAR DIFFUSE, IN-STENT RESTENOTIC TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 15MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION, HOWEVER, THE BALLOON RUPTURED ON SECOND INFLATION AT 16 ATMOSPHERES. A 3.00MM X 15MM APEX¿ BALLOON CATHETER WAS ALSO USED AND DURING FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICES WERE COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH 3.0X15 NC QUANTUM APEX BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7374317 ↗
• MalfunctionMay 15, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.00 MM X 15 MM APEX¿ BALLOON CATHETER WAS ADVANCED TO DILATE A CHRONIC TOTALLY OCCLUDED (CTO) LESION; HOWEVER, UPON INFLATION AT 13-14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER APEX¿ BALLOON CATHETER OF THE SAME SIZE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6567650 ↗
• MalfunctionMay 10, 2017Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 3.00MM X 15MM APEX¿ BALLOON CATHETER, WHEN THE STYLET WAS REMOVED FROM THE TIP OF THE BALLOON, IT WAS NOTED THAT THE SHAFT SEPARATED AT THE PROXIMAL MONORAIL PORT. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.00MM X 15MM APEX BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 6559404 ↗

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