Quantum™ Maverick™ H7493808015350Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 08714729392804), received between Dec 13, 2016 and Jun 25, 2025 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Break” (20 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON UNPACKING, THE BALLOON RUPTURED. THE DEVICE WAS IMMEDIATELY REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED OUTSIDE THE PATIENT'S BODY AFTER THE PACKAGE WAS OPENED. THE PATIENT REMAINED IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325556 ↗
• MalfunctionApr 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DURING UNPACKING OF A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826804 ↗
• MalfunctionDec 3, 2024Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT FROZE ON WIRE OCCURRED. A 3.5 MM X 15 MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON WITHDRAWAL, THE GUIDEWIRE GOT STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS ABOUT 80% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. THE DEVICE WAS DIFFICULT TO ADVANCE ON THE GUIDEWIRE, AND AFTER POST DILATION, THE DEVICE BECAME STUCK ON THE GUIDEWIRE AND WAS DIFFICULT TO REMOVE. AFTER MULTIPLE TRIES, BOTH DEVICES WERE SLOWLY REMOVED TOGETHER AS ONE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835283 ↗
• MalfunctionJul 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE USED OF THE BALLOON, THE PHYSICIAN FELT THAT THE CONNECTION BETWEEN THE OPERATING ROD AND THE BALLOON CATHETER WAS ABOUT TO BE FRACTURED. THE BALLOON WAS IMMEDIATELY REMOVED, AND THE DEVICE WAS COMPLETELY FRACTURED AFTER REMOVAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671741 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE PATIENT WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS DETACHED FROM THE SHAFT AND COULD NOT BE USED SUCCESSFULLY. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19452275 ↗
• MalfunctionNov 2, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER, THE DELIVERY SHAFT WAS FOUND TO BE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714026 ↗
• MalfunctionDec 21, 2021Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14-DEC-2021. IT WAS REPORTED THAT BALLOON DAMAGE WAS ENCOUNTERED. DURING PREPARATION OF A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE BALLOON WAS PARTIALLY EXPANDED. 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 BLOOD INSIDE THE MANIFOLD AND A SHAFT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056733 ↗
• MalfunctionOct 5, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS HOSPITALIZED FOR ACUTE MYOCARDIAL INFARCTION, AND UNDERWENT EMERGENCY CORONARY ARTERY DRUG-COATED STENT IMPLANTATION. AFTER STENT IMPLANTATION, POOR INFLATION ON THE PROXIMAL END OF THE STENT WAS OBSERVED, AND THE STENT WAS PREPARED FOR STENT MOLDING. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS SLIGHTLY TWISTED WHEN ENTERING INTO THE Y VALVE, AND THE CONNECTION SHAFT WAS FRACTURED. THE BROKEN BALLOON WAS THEN REMOVED FROM THE Y VALVE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576092 ↗
• MalfunctionJul 12, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT SHAFT KINK WERE ENCOUNTERED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFED RIGHT CORONARY ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS USED, HOWEVER THE DEVICE FRACTURED BEFORE THE CATHETER WAS DELIVERED. 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 HYPOTUBE WAS SEPARATED 87.9CM FROM STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154285 ↗
• MalfunctionDec 16, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09DEC2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR USE; HOWEVER, DURING PROCEDURE, THE DELIVERY SHAFT WAS KINKED. THE DEVICE WAS COMPLETELY REMOVED BY SIMPLY PULLING IT OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11018823 ↗
• MalfunctionOct 6, 2020Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16-SEP 2020. IT WAS REPORTED THAT INFLATION FAILURE OCCURRED. THE 90% STENOSED, 20MM X 4.5MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE THE PHYSICIAN FOUND THE STENT COULD NOT STICK WELL TO THE VESSEL AS THE BALLOON FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT'S COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638016 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE SHAFT WAS FRACTURED OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10613711 ↗
• MalfunctionSep 2, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 20MM IN LENGTH TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED, 3.5MM IN DIAMETER LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE FRACTURED AT 10CM FROM THE PROXIMAL END OF THE BALLOON. THE DEVICE WAS SIMPLY PULLED OUT AND NO SEGMENT WAS LEFT INSIDE THE PATIENT. 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 10486391 ↗
• MalfunctionJun 23, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING ADVANCING, THE BALLOON DELIVERY SHAFT FRACTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 10184893 ↗
• MalfunctionJun 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MIDDLE AND DISTAL END OF LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. 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 10146385 ↗
• MalfunctionApr 15, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED, 3.5MM X 15MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE WAS KINKED AND FRACTURED AT ABOUT 5CM FROM THE DISTAL END OF THE BALLOON. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962157 ↗
• MalfunctionJan 28, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 75% STENOSED, 3.0MMX38MM TARGET LESION WAS LOCATED IN THE TORTUOUS AND MODERATELY CALCIFIED PROXIMAL AND MIDDLE OF THE LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON SHAFT DELIVERY SYSTEM GOT KINKED AND FRACTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9639711 ↗
• MalfunctionDec 17, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, IT WAS NOTED THAT THE BALLOON DELIVEY SHAFT WAS FRAQCTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9482417 ↗
• MalfunctionDec 11, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AFTER THE 3.5MM X 15MM QUANTUM MAVERICK WAS INTRODUCED INSIDE THE PATIENT IT WAS NOTED THAT THE MIDDLE AND DISTAL END OF THE BALLOON DELIVERY SHAFT WERE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE FRACTURE WAS NEAR THE DISTAL PORTION OF THE DEVICE AND IT WAS COMPLETELY AND SIMPLY REMOVED WITHOUT ANY INTERVENTION PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9455620 ↗
• MalfunctionDec 9, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27NOV2019. IT WAS REPORTED THAT SHAFT BENT/KINKED OCCURRED. THE 90% STENOSED, 3.5X15MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, THE DELIVERY SHAFT OF THE BALLOON WAS KINKED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437809 ↗
• MalfunctionSep 5, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TAREGT LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLCIATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8965604 ↗
• MalfunctionJul 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28JUN2019. THIS DEVICE WAS RECEIVED WITH NO REPORTED ISSUES. HOWEVER, UPON REVIEW OF THIS DEVICE, THE HYPOTUBE WAS SEPARATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8813556 ↗
• 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 STENOSED TARGET LESION WAS LOCATED IN LFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 15MM 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 LONGITUDINAL TEAR IN THE INFLATION LUMEN AND GUIDEWIRE LUMEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813495 ↗
• MalfunctionJun 12, 2019Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21MAY2019. IT WAS REPORTED THAT INFLATION FAILURE OCCURRED. THE 90% STENOSED, 15MMX3.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION BUT WOULD NOT INFLATE DESPITE PRESSURE APPLIED. THERE WERE NO VISIBLE PINHOLE NOTED ON THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED BALLOON TORN LONGITUDINAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8691055 ↗
• MalfunctionJun 7, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED CORONARY ARTERY. A 3.5MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE DELIVERY SHAFT FRACTURED AND THE BROKEN PART WAS OUTSIDE THE PATIENT. THE DEVICE WAS COMPLETELY REMOVED AND 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 8678962 ↗

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-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-0031-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051