Maverick® H7492062020150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729224433), received between Apr 19, 2017 and Apr 19, 2017 — 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.

• InjuryApr 19, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT SHAFT BREAK AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RAMUS ARTERY. A 20MM 1.50 MAVERICK BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, AFTER INFLATING THE DEVICE, IT WAS NOTED THAT THE RADIOPAQUE MARKER WAS DRIFTING AHEAD AND THEY THOUGHT THE BALLOON MOVED FORWARD. THE BALLOON WAS DEFLATED AND RECAPTURED INSIDE THE GUIDE CATHETER. THE SHAFT WAS BROKEN INTO MULTIPLE PIECES. THE ENTIRE GUIDE CATHETER, GUIDEWIRE AND BALLOON CATHETER WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MAVERICK BALLOON CATHETER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6504714 ↗

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-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