Apex™ H7493895908200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729475361), received between Jul 12, 2017 and Jul 12, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RAMUS ARTERY. AFTER A GUIDE WIRE CROSSED THE LESION, A 2.00 MM X 8 MM APEX¿ BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PHYSICIAN THEN REMOVED THE WIRE AND THE BALLOON; HOWEVER, IT WAS NOTED UNDER FLUOROSCOPY THAT THE BALLOON WAS STILL IN THE ARTERY WHILE THE BALLOON SHAFT WAS OUT OF THE PATIENT'S BODY. SUBSEQUENTLY, A SNARE WAS USED AND THE BALLOON WAS SUCCESSFULLY REMOVED FORM THE PATIENT'S BODY. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED HOME THE NEXT DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6705973 ↗

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