Apex™ H7493895920300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729475750), received between Mar 28, 2018 and Nov 7, 2023 — classified as 1 injury, 3 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 3.00MM X 20MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED AND LEFT A STAIN IN THE ARTERY. THE DEVICE WAS REMOVED, AND ANOTHER 3.00MM X 20MM APEX BALLOON CATHETER WAS ADVANCED, BUT THE BALLOON ALSO RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH AN NC QUANTUM BALLOON, AND IMPLANTATION OF A SYNERGY XD DRUG-ELUTING STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083126 ↗
• MalfunctionNov 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 3.00MM X 20MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED AND LEFT A STAIN IN THE ARTERY. THE DEVICE WAS REMOVED, AND ANOTHER 3.00MM X 20MM APEX BALLOON CATHETER WAS ADVANCED, BUT THE BALLOON ALSO RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH AN NC QUANTUM BALLOON, AND IMPLANTATION OF A SYNERGY XD DRUG-ELUTING STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18076532 ↗
• InjuryJan 20, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A 3.00MM X 20MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING REMOVAL OF THE BALLOON, THE SHAFT OF THE BALLOON FRACTURED. THE PHYSICIAN SNARED THE REST OF THE BALLOON OUT OF THE GUIDE CATHETER. ALL ITEMS WERE REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216352 ↗
• MalfunctionMar 28, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00MM X 20MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, RESISTANCE DURING ADVANCING WAS ENCOUNTERED AND THE SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7378300 ↗

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-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
• 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