Maverick²™ H7493892809250Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729369899), received between Nov 20, 2018 and Dec 8, 2020 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90% STENOSED, 16MM IN LENGTH, ECCENTRIC, DE NOVO TARGET LESION WITH A BEND OF >45 AND <90 DEGREES WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY WITH A 3.00MM VESSEL DIAMETER. AFTER A 6F EBU 3.5 GUIDE CATHETER WAS ENGAGED AND A NON-BOSTON SCIENTIFIC GUIDEWIRE CROSSED THE LESION, A 2.50MM X 9MM MAVERICK BALLOON CATHETER WAS TRIED TO INSERT IN THE GUIDE CATHETER. HOWEVER, WHILE NEGOTIATING THE BALLOON CATHETER, THE SHAFT BROKE AT APPROXIMATELY 24CM FROM THE HUB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH 2.00MM X 9MM MAVERICK BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10968232 ↗
• MalfunctionNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24-OCT-2018. A 2.50MM X 9MM MAVERICK 2 BALLOON CATHETER WAS RETURNED WITH NO REPORTED ALLEGATION, HOWEVER, INVESTIGATION RESULTS REVEALED THE SHAFT DETACHED/SEPARATED. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED MULTIPLE KINKS ALONG THE HYPOTUBE. THE HYPOTUBE IS SEPARATED 66.1CM FROM THE HUB. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. THERE IS BLOOD PRESENT IN THE GUIDE WIRE LUMEN AND ON THE BALLOON FOLDS. THE BALLOON IS PARTIALLY LOOSELY FOLDED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS FOUND MULTIPLE KINKS AND A SEPARATED HYPOTUBE. THE HYPOTUBE APPEARED TO BE KINKED PRIOR TO SEPARATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8090978 ↗

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-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