Maverick® H7492062012200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729260288), received between Jul 25, 2017 and Jul 25, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.

• MalfunctionJul 25, 2017Leak/Splash; Device Damaged Prior to Use; Leak/Splash; Device Damaged Prior to Use

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12-JUL-2017. IT WAS REPORTED THAT HUB LEAKAGE OCCURRED. DURING PREPARATION OF A 12 MM 2.00 MAVERICK BALLOON CATHETER, IT WAS NOTED THAT A LOT OF AIR KEPT GETTING BACK INTO THE SYRINGE. THE STOPCOCKS AND THE SYRINGE WERE SWITCHED OUT HOWEVER THE SAME ISSUE WAS ENCOUNTERED. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. WHEN THE CASE WAS DONE, THE BALLOON WAS RE-INFLATED AND IT WAS NOTED THAT THE ACTUAL MANIFOLD WAS LEAKING. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT HOLE/PERFORATION.

  Patient problems: No Patient Involvement

  MAUDE report 6741076 ↗

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