Quantum™ Maverick™ H7493808015300Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 08714729392781), received between Dec 22, 2016 and Feb 24, 2026 — classified as 2 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Contamination; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. THE 93% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 15MM QUANTUM? MAVERICK? BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON UNPACKING, IT WAS NOTICED THAT THE BALLOON WAS CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430540 ↗
• MalfunctionJan 4, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15DEC2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT BALLOON HAD A LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954128 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.0MM X 15MM QUANTUM MAVERICK WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE SHAFT BREAK OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066470 ↗
• MalfunctionMay 12, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WITH A LENGTH OF 20 MM, A VESSEL DIAMETER OF 3.5 MM WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.0 MM X 15 MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON SHAFT DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE, AND NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005188 ↗
• InjuryAug 23, 2024Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUES AND REMOVAL DIFFICULTY OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE PATIENT WAS BEING TREATED FOR ACUTE MYOCARDIAL INFARCTION AND RECEIVED EMERGENCY CORONARY INTERVENTIONAL THERAPY. THE MODERATE TO SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. DURING THE PROCEDURE, AFTER NEGATIVE PRESSURE WAS APPLIED, THE BALLOON WOULD NOT DEFLATE. THE PRESSURE PUMP WAS IMMEDIATELY USED FOR REPEATED SUCTION, AND THE DEVICE WAS FINALLY AND SUCCESSFULLY WITHDRAWN FROM THE PATIENT. REPEATED ANGIOGRAPHY WAS PERFORMED, AND IT WAS CONFIRMED THAT NO VASCULAR DAMAGE WAS FOUND IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20056093 ↗
• MalfunctionDec 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS HOSPITALIZED DUE TO ACUTE MYOCARDIAL INFARCTION. FOLLOWING THE CONSENT OF THE FAMILY, AN EMERGENCY PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS BEING PERFORMED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT CIRCUMFLEX ARTERY. AFTER THE STENT WAS PLACED, A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE THIRD INFLATION AT 14 ATMOSPHERES FOR 5 SECONDS, THE BALLOON BURST. NEITHER THE BALLOON NOR A SEGMENT OF THE BALLOON DETACHED INSIDE THE PATIENT AFTER IT BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. DURING THE PROCEDURE, THE PHYSICIAN SUSPECTED MYOCARDIAL STAINING AND VASCULAR RUPTURE. THE PATIENT THEN UNDERWENT AN ULTRASOUND. PERICARDIAL EFFUSION NOR BLOODING WAS NOT FOUND DURING THE ULTRASOUND. AFTER AN HOUR OF OBSERVATION, ULTRASOUND RE-EXAMINATION WAS PERFORMED AND NOTHING ABNORMAL WAS DETECTED. THE BLOOD VESSELS WERE UNOBSTRUCTED, NO LEAKAGE WAS OBSERVED, AND THE PATIENT WAS NOT AFFECTED. THE PATIENT WAS SENT BACK TO THE WARD FOR FURTHER OBSERVATION. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18261487 ↗
• InjuryJun 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND VASCULAR BLEEDING OCCURRED. THE PATIENT UNDERWENT CARDIAC INTERVENTION AND A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED AS THE PRESSURE INPUT WAS TOO HIGH CAUSING THE BLOOD VESSEL TO LEAK. AFTER HEMOSTASIS WAS GAINED WITHOUT INTERVENTION, THE DEVICE WAS PULLED OUT AND REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT WAS NORMAL POST PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17132017 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE BALLOON WAS FRACTURED. THE DEVICE WAS NOT USED, 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 15814691 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USED. HOWEVER, UPON UNPACKING, THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15365794 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE 60% CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON WAS ADVANCED FOR DILATATION; HOWEVER, IT WAS NOTED THAT THE DELIVERY SHAFT OF THE BALLOON WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13256394 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE 68% CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE DELIVERY SHAFT OF THE BALLOON WAS FRACTURED. THE DEVICE DID NOT ENTER THE PATIENT'S BODY COMPLETELY, SO IT WAS COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 13255977 ↗
• MalfunctionSep 30, 2021Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT DEVICE CONTAMINATION MIGHT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILLATATION. HOWEVER, THE DEVICE INNER PACKAGE WAS OPENED AND EXPOSED TO AIR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12556747 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345658 ↗
• MalfunctionJun 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971509 ↗
• MalfunctionApr 7, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL END OF THE LEFT CIRCUMFLEX ARTERY. AFTER STENT IMPLANTATION, A 3.0MM X 15MM QUANTUM MAVERICK WAS USED FOR POST-DILATION. HOWEVER, DURING ADVANCEMENT, THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS REMOVED DIRECTLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628512 ↗
• MalfunctionMar 24, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT WAS KINKED. 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 BALLOON LONGITUDINAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11565669 ↗
• MalfunctionJan 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE EFT CORONARY ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

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

  MAUDE report 11150072 ↗
• MalfunctionDec 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED, 21MM X 3.0MM TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT CORONARY ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION BUT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED ONCE AND RUPTURED AT 15 ATMOSPHERES FOR 20 SECONDS.

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

  MAUDE report 11013767 ↗
• MalfunctionDec 8, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 98% STENOSED, 20MMX2.75MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CRONARY ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, THE SHAFT WAS KINKED AND UPON REMOVAL, THE SHAFT WAS FRACTURED OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

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

  MAUDE report 10969209 ↗
• MalfunctionNov 30, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MIDDLE OF LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE MIDDLE OF THE DELIVERY SHAFT WAS FRACTURED AND THE FRACTURED POINT WAS STILL OUTSIDE THE PATIENT'S BODY. THE DEVICE WAS SIMPLY PULLED OUT AND 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 Consequences Or Impact To Patient

  MAUDE report 10919198 ↗
• MalfunctionOct 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING PROCEDURE, THE BALLOON RUPTURED WHEN THE PRESSURE WAS APPLIED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10668193 ↗
• MalfunctionOct 9, 2020Break; Break

  IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED AND THE LEFT ANTERIOR DESCENDING ARTERY WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED. THE FRACTURE OCCURRED IN THE MIDDLE OF THE SHAFT AND THE DEVICE WAS SIMPLY REMOVED AS A WHOLE ALL TOGETHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10655303 ↗
• MalfunctionOct 8, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE DELIVERY SHAFT GOT FRACTURED. THE FRACTURED PART WAS SIMPLY PULLED OUT WITHOUT ANY INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10649759 ↗
• MalfunctionAug 17, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED, 3.5X24MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT SHAFT WAS KINKED AND FRACTURED AT 70CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417265 ↗
• MalfunctionJul 2, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCE FOR DILATATION; HOWEVER, THE DELIVERY SHAFT WAS FRACTURED FROM THE MIDDLE. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224461 ↗

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