Apex™ H7493895920250Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729475736), received between Mar 14, 2017 and Oct 6, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. A 2.50MM X 20MM APEX BALLOON CATHETER SELECTED FOR USE. HOWEVER, DURING PREPARATION, BALLOON PINHOIE WAS NOTED PRIOR TO DEVICE INSERTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580762 ↗
• MalfunctionOct 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 20MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION, THE BALLOON WOULD NOT INFLATE. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THERE WAS A PINHOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204204 ↗
• MalfunctionMar 19, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. A 2.50MM X 20MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON CATHETER GOT STUCK ON THE GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434115 ↗
• InjuryNov 29, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MINIMALLY TORTUOUS, SEVERELY CALCIFIED, RIGHT CORONARY ARTERY. AFTER A GUIDE WIRE AND GUIDE CATHETER CROSSED THE LESION, A 1.5 X 2.0 BALLOON CATHETER WAS USED TO SUCCESSFULLY DILATE THE PROXIMAL GUIDE CATHETER. A 2.50MM X 20MM WAS ADVANCED TO TREAT THE LESION AND DURING THE THIRD OR FOURTH INFLATION ABOVE RATED BURST PRESSURE, THE BALLOON RUPTURED. WHEN THE DEVICE WAS PULLED OUT OF THE PATIENT, A PIECE OF THE RUPTURED BALLOON WAS CAUGHT IN THE LESION. THE TIP OF THE BALLOON CATHETER SHEARED OFF AND REMAINED IN THE LESION. THE PHYSICIAN TRIED UNSUCCESSFULLY TO SNARE THE BALLOON FRAGMENT. A SURGEON WAS CONSULTED BUT THE SURGEON DID NOT WANT TO TAKE THE PATIENT TO SURGERY TO REMOVE THE FRAGMENT SO THE PHYSICIAN STENTED THE BALLOON FRAGMENT IN THE OSTIUM OF THE RCA. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING OKAY AT THE END OF THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7068395 ↗
• MalfunctionMay 19, 2017Material Perforation; Device Damaged by Another Device; Material Perforation; Device Damaged by Another Device

  IT WAS REPORTED THAT SHAFT PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. AFTER A GUIDEWIRE WAS PLACED, A 2.50MM X 20MM APEX BALLOON CATHETER WAS BACK LOADED ON TO THE WIRE. HOWEVER, THE GUIDE WIRE PERFORATED THE WIRE LUMEN OF THE DEVICE OUTSIDE OF THE PATIENT'S BODY. THE DEVICE WAS REMOVED AND 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 6578651 ↗
• MalfunctionMar 14, 2017Failure to Advance; Failure to Advance

  REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2017. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE (B)(4) STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS CORONARY ARTERY. A 2.50MM X 20MM APEX¿ BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED LONGITUDINAL BALLOON TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6404663 ↗

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-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-0031-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051