Apex™ H7493895915350Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729475651), received between Nov 30, 2016 and Nov 30, 2016 — classified as 1 injury.

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.

• InjuryNov 30, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID: 2134265-2016-10738; 2134265-2016-10739; 2134265-2016-10744; 2134265-2016-10745; 2134265-2016-10746; 2134265-2016-11383 AND 2134265-2016-11384. IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. TWO TARGET LESIONS WERE IDENTIFIED. THE TARGET LESION #1 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD) AND THE TARGET LESION #2 WAS LOCATED IN THE LATERAL 1ST DIAGONAL BRANCH ARTERY. AFTER PERFORMING ROTABLATION WITH A 1.50MM ROTALINK¿ PLUS, A 2.5MM X 15MM APEX¿ BALLOON CATHETER WAS ADVANCED TO THE MLAD FOR PREDILATION. THE BALLOON WAS INFLATED AT 16 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS THEN REMOVED FROM THE MLAD AND WAS ADVANCED TO THE LATERAL 1ST DIAGONAL BRANCH AND WAS INFLATED AT 14 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED AND A 2.5 X 24 SYNERGY II (DES) WAS ADVANCED TO TREAT THE MLAD. THE STENT WAS DEPLOYED AT 18 ATMOSPHERES FOR 20 SECONDS. THE STENT DELIVERY SYSTEM WAS REMOVED AND A 3.0 X 12 SYNERGY II DES WAS THEN ADVANCED TO THE LATERAL 1ST DIAGONAL BRANCH. THE STENT WAS DEPLOYED AT 16 ATMOSPHERES FOR 12 SECONDS AND THE SDS WAS REMOVED. A 3.25X15MM NON-BSC BALLOON CATHETER WAS THEN ADVANCED TO THE MLAD HOWEVER THE DEVICE WAS EVENTUA

  Patient problems: Perforation of Vessels

  MAUDE report 6135684 ↗

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