Apex™ Flex H7493895912150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729758464), received between Jul 27, 2022 and Jul 27, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 27, 2022Break; Material Rupture; Detachment of Device or Device Component; Break; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH HEART DISEASE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM X 12MM APEX FLEX BALLOON CATHETER WAS ADVANCED FOR DILATION. THE PHYSICIAN USED A RUNTHROUGH, AND WAS ABLE TO GO RIGHT IN WITH APEX FLEX BALLOON CATHETER. THE APEX FLEX BALLOON CATHETER WAS INFLATED AND RUPTURED ON THE FIRST INFLATION. THE DEVICE WAS REMOVED WITH NO ISSUE. HOWEVER, PATIENT ANGIOGRAPHY REVEALED THE BALLOON MARKERS AND A PORTION OF THE OF THE SHAFT WAS STILL INSIDE THE BODY. THE PHYSICIAN TRIED FOR AN HOUR TO REWIRE THE DEVICE BUT FAILED. PATIENT WAS NOT SURGICAL CANDIDATE DUE TO AGE AND RISK FACTORS AND SNARING WAS NOT DONE, THE FAMILY DECIDED AGAINST IT WHEN GIVEN THE OPTION DUE TO POTENTIAL RISK FACTORS. AFTER HOURS AND MANY CONSULTATIONS WITH THE EXTENDED PHYSICIAN TEAM AND PATIENT FAMILY, THE DETACHED PORTION OF THE BALLOON WAS LEFT IN THE BODY AND THE PATIENT WAS PUT ON ANTI-COAGULATION THERAPY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS STABLE AND WAS EXPECTED TO BE DISCHARGED AND FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 15113359 ↗

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