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Maverick²™ H7493892812200Recalls & reported problems

Boston Scientific Corporation · PTCA Dilatation Catheter · Class 2

All models of Maverick² (30)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Boston Scientific Maverick² balloon dilatation catheter is used to open narrowed coronary arteries during angioplasty. The 36 reports mostly describe the balloon or its shaft breaking or rupturing during the procedure, along with difficulty advancing the catheter. One report mentions a death and one an injury. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
37
Deaths reported
2
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 08714729369967), received between Feb 23, 2017 and Sep 17, 2026 — classified as 2 deaths, 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Break” (15 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break15
  • Material Rupture8
  • Failure to Advance5
  • Adverse Event Without Identified Device or Use Problem3
  • Difficult to Advance3
  • Inflation Problem2
  • Material Integrity Problem2
  • Device Damaged Prior to Use1

Patient problems

  • No Consequences Or Impact To Patient16
  • No Clinical Signs, Symptoms or Conditions14
  • No Known Impact Or Consequence To Patient3
  • Cardiac Arrest2
  • Low Blood Pressure/ Hypotension2
  • No Patient Involvement2
  • Bradycardia1
  • Death1

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

  • DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

    It was reported that the patient died.The patient presented with 95% stenosis of the left anterior descending artery (LAD) and 90% stenosis of the right coronary artery (RCA) with high calcium and tortuosity of the vessel. After the bed was prepared with a 1.50 x 15 mm Maverick 2 balloon a non-Boston Scientific (non-BSC) stent was deployed and post dilated successfully. The proximal RCA was then pre-dilated with a 2.00 x 12 mm Maverick 2 balloon and another non-BSC stent was successfully deployed and post-dilated. After deployment of the second stent in the RCA, a non-BSC drug coated balloon was used at the proximal end. After completion of the procedure, the patient was stable and sent to the coronary care unit for post-procedural monitoring. During the night, the patient developed hypotension and went into cardiac arrest. Cardiopulmonary Resuscitation was immediately started and continued. Once the pressure got done and the patient did not come back, they were declared expired. An autopsy was not performed.

    Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

    MAUDE report 50800966 ↗
  • MalfunctionJan 17, 2025Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DUE TO THREE VESSEL DISEASE OF CORONARY HEART DISEASE, THE PATIENT UNDERWENT DRUG-ELUTING CORONARY STENT IMPLANTATION, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, CORONARY ANGIOGRAPHY WITH SINGLE CATHETER, AND RIGHT BRACHIAL ARTERY PUNCTURE. A 2.00 MM X 12 MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS BROKEN BEFORE STENT IMPLANTATION AND A NEW BALLOON WAS IMMEDIATELY REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21180147 ↗
  • MalfunctionJun 28, 2024Nonstandard Device; Material Rupture; Nonstandard Device; Material Rupture

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. AFTER THE LESION WAS PRE-DILATED USING A SEMI COMPLIANT BALLOON, A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING SECOND INFLATION AT HIGH PRESSURE, THE BALLOON FAILED TO DILATE AND WAS RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19635465 ↗
  • MalfunctionMay 22, 2024Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INSERTION OF THE DEVICE INTO THE GUIDE CATHETER, THE SHAFT BROKE. THE DEVICE WAS PULLED OUT TOGETHER WITH THE GUIDE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2 X 12 MAVERICK BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS DOING WELL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19372545 ↗
  • MalfunctionMar 14, 2024Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE DELIVERY SHAFT FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT STATUS WAS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18904025 ↗
  • MalfunctionOct 5, 2023Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 2.00MM X 12MM MAVERICK BALLOON CATHETER, THE SHAFT WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17882349 ↗
  • MalfunctionJan 6, 2023Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING. AFTER A 6F NON-BSC GUIDE CATHETER AND A NON-BSC GUIDEWIRE WERE CROSSED THE LESION, A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING THE PROCEDURE, IT FAILED TO CROSS THE LESION DUE TO CALCIFICATION AND WHEN INFLATED AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.0X12MM NON-BSC BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16116067 ↗
  • MalfunctionMay 4, 2022Difficult to Advance; Difficult to Advance

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20-APR-2022. IT WAS REPORTED THAT ADVANCING DIFFICULTIES OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CIRCUMFLEX ARTERY. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE BUT WAS HAVING DIFFICULTIES IN ADVANCING THE DEVICE. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14282039 ↗
  • MalfunctionJan 14, 2022Material Rupture; Material Rupture

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). THE DE NOVO TARGET LESION WAS LOCATED IN THE CORONARY VESSEL. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS FOUND OUT THAT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAVERICK BALLOON CATHETER. THERE WERE NO COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS IN STABLE CONDITION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13257117 ↗
  • MalfunctionOct 27, 2021Break; Break

    IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A MAVERICK 2 MR, 2.00MM X 12MM WAS SELECTED FOR TREATMENT. DURING PREPARATION AS THE BALLOON PROTECTOR WAS BEING REMOVED, IT WAS OBSERVED THAT THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS FINE POST PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12703882 ↗
  • MalfunctionOct 1, 2021Material Rupture; Material Rupture

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AFTER ENGAGING THE LESION WITH A NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER AND CROSSED WITH A NON-BSC GUIDE WIRE, A 2.00MM X 12MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 2.50 X12 NC QUANTUMA APEX BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12565565 ↗
  • MalfunctionSep 2, 2021Material Integrity Problem; Material Integrity Problem

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, THE DEVICE WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE DEVICE HAD BEEN INSIDE THE PATIENT AND HAD A BALLOON PINHOLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12415616 ↗
  • MalfunctionAug 26, 2021Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.00MM X 12MM MAVERICK 2 BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PREPARATION, IT WAS NOTICED THAT THE SHAFT WAS FRACTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12371733 ↗
  • MalfunctionAug 24, 2021Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY. A 2.00MM X 12MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, UPON PRE-DILATATION, A SHAFT BREAK OCCURRED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE . THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12358998 ↗
  • MalfunctionJun 18, 2021Material Integrity Problem; Material Integrity Problem

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS SELECTED TO TREAT A PATIENT WITH CORONARY ARTERY DISEASE. IT WAS NOTED THAT THE BALLOON WAS DAMAGED. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12025335 ↗
  • MalfunctionOct 27, 2020Difficult to Advance; Difficult to Advance

    IT WAS REPORTED THAT A BALLOON DEVICE COULD NOT BE PLACED ONTO A WIRE. DURING PREPARATION AND WHILE OUTSIDE THE PATIENT, A 2.00MM X 12MM MAVERICK BALLOON COULD NOT BE PLACED ONTO THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. HOWEVER, THE DEVICE WAS RETURNED AND ANALYSIS REVEALED OUTER SHAFT DAMAGE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10742010 ↗
  • MalfunctionAug 10, 2020Material Rupture; Material Rupture

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 12MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT RATED BURST PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10388697 ↗
  • MalfunctionMay 4, 2020Material Rupture; Material Rupture

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION AREA WAS LOCATED IN THE CORONARY ARTERY. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION ALONG WITH A 145, 5-IN-6 GUIDEZILLA EXTENSION GUIDE CATHETER. HOWEVER, DURING THE PROCEDURE THE BALLOON WAS GASHED BY THE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10020923 ↗
  • MalfunctionApr 17, 2020Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE THE SHAFT FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9972997 ↗
  • MalfunctionJan 22, 2020Inflation Problem; Inflation Problem

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-JAN-2020. IT WAS REPORTED THAT INFLATION FAILURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, DURING PROCEDURE, THE BALLOON FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT SEPARATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9617200 ↗
  • MalfunctionJan 15, 2020Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30DEC2019. IT WAS REPORTED THAT SHAFT KINK AND INFLATION FAILURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX CORONARY ARTERY. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION, BUT THE SHAFT WAS KINKED AND THE BALLOON COULD NOT INFLATE PROPERLY. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT SEPARATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9590435 ↗
  • MalfunctionDec 17, 2019Break; Break

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 75% STENOSED, 18MMX2.0MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A 2.00MM X 12MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT WAS KINKED AND WAS FRACTURED. THE FRACTURED PART WAS REMOVED FROM THE PATIENT'S BODY. 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 9481994 ↗
  • MalfunctionOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07-OCT-2019. A 2.00MMX12MM MAVERICK BALLOON CATHETER WAS RETURNED WITHOUT REPORTED ALLEGATION. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9222091 ↗
  • MalfunctionJul 22, 2019Failure to Advance; Failure to Advance

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28JUN2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION AFTER MULTIPLE ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SEPARATED HYPOTUBE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8813575 ↗
  • MalfunctionJun 24, 2019Material Rupture; Material Rupture

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 12MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURED WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8729744 ↗

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-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

Other Catheters, transluminal coronary angioplasty, percutaneous devices

All Catheters, transluminal coronary angioplasty, percutaneous devices →

Sources and updates

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