Apex™ H7493895912250Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729475491), received between Nov 18, 2016 and Nov 10, 2023 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED VIA USER MEDWATCH (B)(4) THAT SHAFT BREAK OCCURRED. A 2.50MM X 12MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN REMOVING THE BALLOON OVER THE GUIDEWIRE, THE BALLOON DELIVERY SYSTEM BROKE AT THE RX PORT ON THE SHAFT. THE CATHETER AND THE WIRE WERE REMOVED AS ONE UNIT, AND THE DISTAL END OF THE BALLOON CATHETER WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110179 ↗
• InjuryJan 6, 2022Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACH AND UNRETRIEVED DEVICE FRAGMENT LEAD TO ADDITIONAL SURGERY OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.50MM X 12MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THIRD INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. PHYSICIAN AGAIN ATTEMPTED TO PULL THE BALLOON OUT. AT THAT TIME THE BALLOON PORTION DETACHED FROM THE SHAFT OF THE DEVICE. THE SHAFT WAS SUCCESSFUL REMOVED BUT THE ACTUAL BALLOON PORTION REMAINED STUCK IN THE CORONARY ARTERY. PATIENT IS SCHEDULED TO UNDERGO BYPASS SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13175869 ↗
• MalfunctionDec 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-CALCIFIED CORONARY ARTERY. A 2.50MM X 12MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT BELOW THE NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10956237 ↗
• MalfunctionOct 5, 2020Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 2.50MM X 12MM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTICED THAT THE PACKAGE WAS DAMAGED. THE INNER POUCH OF THE PACKAGE WAS NOT INTACT AND A VISIBLE HOLE WAS OBSERVED. THE STERILITY OF THE DEVICE WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10626673 ↗
• InjurySep 12, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL APPROACH. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED CORONARY ARTERY. A 2.50MM X 12MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON WITHDRAWAL, THE BALLOON COULD NOT BE REMOVED AFTER IT WAS INFLATED. SUBSEQUENTLY, A 0.35 STABILIZING GUIDE WIRE ADVANCED AND WAS USED TO REMOVE THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9014480 ↗
• MalfunctionMay 23, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT INCORRECT DEVICE WAS INSIDE THE PACKAGING. DURING PREPARATION, AN NC EMERGE BOX WAS OPENED. HOWEVER, A 2.50MM X 12MM APEX BALLOON CATHETER WAS FOUND INSIDE THE PACKAGING. NO PATIENT INVOLVED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8637929 ↗
• MalfunctionApr 19, 2018Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26-MAR-2018. IT WAS REPORTED THAT DIFFICULTY LOADING WIRE OCCURRED. DURING INTRODUCTION OF A 2.50MM X 12MM APEX¿ BALLOON CATHETER INTO THE WIRE, IT WOULD NOT COME OUT THE WIRE PORT OR THE WIRE LUMEN. SEVERAL MORE ATTEMPTS WERE TRIED WHICH CAUSED THE WIRE TO BE BENT/KINKED AND THE BALLOON WOULD NOT GO OVER THE WIRE WHICH CAUSED THE WIRE LUMEN TO BE DAMAGED. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE AND ANOTHER OF THE SAME BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED TIP DETACHED/SEPARATED.

  Patient problems: No Patient Involvement

  MAUDE report 7445167 ↗
• MalfunctionApr 13, 2017Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED THAT THE STERILE PACKAGE WAS COMPROMISED. DURING UNPACKING OF A 2.50MM X 12MM APEX¿ BALLOON CATHETER, IT WAS NOTED THAT THE PACKAGING WAS COMPROMISED RENDERING THE DEVICE UNSTERILE. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6492377 ↗
• MalfunctionNov 18, 2016Hole In Material; Hole In Material

  IT WAS REPORTED THAT THE DEVICE HAD A HOLE. A 2.50MM X 12MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE HAD A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6114156 ↗

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