Quantum™ Maverick™ H7493808012270Recalls & reported problems
Boston Scientific Corporation · PTCA Dilatation Catheter · Class 2
All models of Quantum Maverick (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Boston Scientific Quantum Maverick balloon dilatation catheter is used to widen narrowed coronary arteries during angioplasty. The 49 reports mostly describe the balloon or its shaft breaking, sometimes found already cracked in the package, plus catheters that would not advance or inflate and balloons that ruptured; 1 report involved a death and 1 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
- 49
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 08714729392668), received between Jan 26, 2017 and Apr 30, 2025 — classified as 1 death, 1 injury, 47 malfunctions.
The most frequently reported specific device problem is “Break” (21 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
Most reported problems
Device problems
- Break21
- Failure to Advance10
- Inflation Problem6
- Material Rupture6
- Material Deformation4
- Material Integrity Problem2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient40
- No Clinical Signs, Symptoms or Conditions8
- Cardiac Tamponade1
- Cardiogenic Shock1
- Death1
- Intimal Dissection1
- No Patient Involvement1
- Perforation of Vessels1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, WHEN THE DEVICE WAS PUT ONTO THE TABLE AFTER BEING UNPACKED, A HAIR WAS FOUND INSIDE THE INNER BAG. THE BOX WAS INITIALLY SEALED AND NO DAMAGED WAS NOTED ON THE STERILE POUCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21939694 ↗MalfunctionApr 17, 2025Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 75% STENOSED, 3.5 MM X 18 MM, WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 12MM QUANTUM? MAVERICK? BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21857111 ↗MalfunctionApr 18, 2023Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS OBSERVED THAT THE BALLOON CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16765547 ↗MalfunctionAug 9, 2021Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT INFLATION FAILURE WERE ENCOUNTERED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED.THE 10X2.75MM IN LENGTH TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS NOT FULLY FILLED AND COULD NOT DILATE THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12297693 ↗MalfunctionAug 3, 2021Inflation Problem; Inflation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26JUL2021. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION, BUT THE BALLOON FAILED TO EXPAND DUE TO LESION CHARACTERISTIC. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12272028 ↗MalfunctionApr 12, 2021Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTICED THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11652520 ↗MalfunctionJan 27, 2021Inflation Problem; Inflation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13-JAN-2021. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE AND DISTAL END OF LEFT CIRCUMFLEX CORONARY ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS USED FOR DILATATION BUT THE BALLOON COULD NOT FULLY INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11239912 ↗MalfunctionDec 24, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 35% STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE OF LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION UPON REACHING THE RATED PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 11072283 ↗MalfunctionNov 30, 2020Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID AND DISTAL RIGHT CORONARY ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE MIDDLE OF THE DEVICE DELIVERY SHAFT WAS FRACTURED. THE FRACTURED PART WAS SIMPLY PULLED OUT 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 Consequences Or Impact To Patient
MAUDE report 10920965 ↗MalfunctionNov 16, 2020Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING INTRODUCTION, THE DELIVERY SHAFT WAS FRACTURED IN TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10844528 ↗MalfunctionNov 10, 2020Material Integrity Problem; Material Integrity Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-OCT-2020. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. DURING PREPARATION OF A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE BALLOON WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED SHAFT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10820786 ↗MalfunctionNov 9, 2020Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE DELIVERY SHAFT WAS FRACTURED AFTER WITHDRAWAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10810166 ↗MalfunctionSep 9, 2020Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL END OF RIGHT CORONARY ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT THE DELIVERY SHAFT GOT FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10507958 ↗MalfunctionAug 12, 2020Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MIDDLE SECTION OF RIGHT CORONARY ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE STENT DELIVERY SHAFT WAS FRACTURED INTO TWO PIECES. THE DEVICE WAS SIMPLY PULLED OUT 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 10398599 ↗MalfunctionAug 11, 2020Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID SECTION OF THE RIGHT CORONARY ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE DELIVERY SHAFT BROKE IN TWO PIECES. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10391550 ↗MalfunctionJul 9, 2020Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 2.75MM X 12MM TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10254588 ↗MalfunctionJan 29, 2020Material Deformation; Material Deformation
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JAN2020. IT WAS REPORTED THAT A KINK OCCURRED. THE 99% STENOSED, 16MMX2.75MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT MAIN CORONARY ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON DELIVERY SHAFT WAS KINKED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HOLE IN THE OUTER SHAFT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9643414 ↗MalfunctionSep 26, 2019Inflation Problem; Inflation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT INFLATION FAILURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON WAS ABLE TO BE INFLATED BUT FAILED TO DILATE IN LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN LONGITUDINAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9125559 ↗MalfunctionJul 12, 2019Failure to Advance; Failure to Advance
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21JUN2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED, 2.75MM X 12MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 8785684 ↗MalfunctionJun 25, 2019Failure to Advance; Failure to Advance
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31-MAY-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED, 12X2.75MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8733015 ↗MalfunctionMay 7, 2019Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A LEFT CIRCUMFLEX ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE DELIVERY SHAFT WAS FRACTURED. 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 8587694 ↗MalfunctionApr 29, 2019Material Deformation; Material Deformation
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08-APR-2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 93% STENOSED, 2.75X11MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT WAS KINKED AT 55CM FROM THE PHYSICIAN'S HAND. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8561673 ↗MalfunctionApr 29, 2019Failure to Advance; Failure to Advance
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-APR-2019. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE 85% STENOSED, 2.75MM X 12MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SEPARATED HYPOTUBE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8561284 ↗MalfunctionApr 29, 2019Break; Break
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-APR-2019. IT WAS REPORTED THAT SHAFT BREAK AT A PORTION THAT CANNOT ENTER THE PATIENT'S BODY OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE IT WAS NOTED THAT THE DELIVERY SHAFT WAS FRACTURED LESS THEN 15CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SEPARATION OF THE HYPOTUBE AT 82.2CM FROM THE HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8561198 ↗MalfunctionMar 25, 2019Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURED. A 2.75MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION THE BALLOON SHAFT GOT FRACTURED. THE DEVICE WAS NEVER INTRODUCED INTO 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 8449396 ↗
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 · TerminatedBoston 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 · TerminatedBoston 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 · TerminatedAce Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
- Z-0031-04 · Aug 20, 2003 · TerminatedAce Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
- Z-0032-04 · Aug 20, 2003 · TerminatedAce 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
- MINI TREK™ 1012270-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous223 reports
- Maverick²™ H7493892815200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous1 death203 reports
- MINI TREK™ 1012270-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous162 reports
- Maverick²™ H7493892820200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous161 reports
- NC TREK 1012454-08Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 recalls59 reports
- TREK™ 1012272-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 deaths158 reports
- NC TREK 1012453-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall84 reports
- NC TREK 1012453-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death83 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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