Apex™ H7493895915250Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729475613), received between Nov 23, 2016 and Jul 12, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 15MM APEX BALLOON WAS SELECTED FOR USE. DURING PREPARATION, THE BALLOON RUPTURED WHEN NEGATIVE WAS PULLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5 X 15 BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14996285 ↗
• MalfunctionNov 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS AN IN-STENT RESTENOSIS LOCATED IN THE PROXIMAL END OF LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50MM X 15MM APEX BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED AND THE DEVICE WAS REMOVED FROM THE PATIENT. A 3.0 X 12MM BSC BALLOON CATHETER WAS THEN ADVANCED FOR POST-DILATATION, FOLLOWED BY THE IMPLANTATION OF A 4.0 X 28MM BSC STENT AND POST-DILATATION AGAIN WITH A 4.5 X 12MM BSC BALLOON CATHETER, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8051359 ↗
• MalfunctionMar 27, 2018Material Rupture; Material Rupture

  SAME CASE AS MDR ID: 2134265-2018-02227. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 40%- 99% STENOSED, TUBULAR DIFFUSE, IN-STENT RESTENOTIC TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. A 2.50MM X 15MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION, HOWEVER, THE BALLOON RUPTURED ON SECOND INFLATION AT 16 ATMOSPHERES. A 3.00MM X 15MM APEX¿ BALLOON CATHETER WAS ALSO USED AND DURING FIRST INFLATION AT 12 ATMOSPHERES THE BALLOON RUPTURED. THE DEVICES WERE COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH 3.0X15 NC QUANTUM APEX BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7374319 ↗
• MalfunctionSep 26, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRODUCT STERILITY WAS COMPROMISED. A 2.50MM X 15MM APEX¿ BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, A HOLE WAS NOTICED IN THE CLEAR INNER PACKAGING. THE DEVICE WAS NEVER USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6895083 ↗
• MalfunctionMay 22, 2017Material Rupture; Material Rupture

  IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED ON INITIAL INFLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6582685 ↗
• 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; 2134265-2016-10747; 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 6135686 ↗
• MalfunctionNov 23, 2016Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.50MM X 15MM APEX¿ BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, THE SHAFT BROKE DURING DELIVERY. THE DEVICE WAS 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 6126329 ↗

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-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
• Z-0030-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011