Quantum™ Maverick™ H7493808015270Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729392774), received between Dec 16, 2016 and Sep 18, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828478 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT CORONARY STENT IMPLANTATION. THE 83% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.75MM X 15MM QUANTUM? MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCESS OF INSERTION, BALLOON DELIVERY SHAFT WAS FRACTURED. 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 24394000 ↗
• MalfunctionJan 27, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY AND INTRACORONARY STENT IMPLANTATION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING BRANCH. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE CATHETER SHAFT FRACTURED INSIDE THE PATIENT. THE SAME GUIDE CATHETER USED FOR THE PROCEDURE WAS UTILIZED TO COMPLETELY RETRIEVE BOTH THE BALLOON AND THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190327 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION OF A NON-BOSTON SCIENTIFIC STENT. HOWEVER, PRIOR TO INFLATION, IT WAS NOTED THAT THE BALLOON WAS BROKEN. THE DEVICE WAS REPLACED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857917 ↗
• MalfunctionNov 8, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18-OCT-2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 95% STENOSED, 2.75MM X 18MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION HOWEVER, DURING THE PROCEDURE, THE DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SEPARATED HYPOTUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775831 ↗
• MalfunctionOct 21, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE PACKAGING WAS UNSEALED. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, PRIOR TO SEDATION, IT WAS NOTICED THAT THERE WAS NO STERILE PROTECTION IN THE BOX OF THE IMAGING CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673505 ↗
• MalfunctionFeb 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION, HOWEVER, DURING INITIAL INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. 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 11358937 ↗
• MalfunctionFeb 4, 2021Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14JAN2021 IT WAS REPORTED THAT SHAFT KINK WAS ENCOUNTERED. THE 95% STENOSED, TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTICED THAT THE DELIVERY SHAFT WAS KINKED. 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. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282883 ↗
• MalfunctionJan 26, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08-JAN-2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE CONNECTOR OF THE BALLOON AND THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATENT COMPLICATIONS AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11233563 ↗
• MalfunctionDec 3, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. WHILE A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS BEING UNPACKED, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10938107 ↗
• MalfunctionJun 24, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29MAY2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 80% STENOSED, 15MM IN LENGTH TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED, 2.75MM IN DIAMETER LEFT CIRCUMFLEX (LCX) ARTERY. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. WHEN THE BALLOON CATHETER CROSSED THE DISTAL END OF LCX, THE BALLOON DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10192256 ↗
• MalfunctionJun 9, 2020Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16-MAY-2020. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE, BUT AFTER UNPACKING, A LEAKING GAS WAS NOTED AND COULD NOT BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SEPARATED SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10134256 ↗
• MalfunctionJan 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED MIDDLE OF LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM PATIENT'S BODY WITHOUT ANY INTERVENTION. 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 9614163 ↗
• MalfunctionAug 20, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31-JUL-2019. IT WAS REPORTED THAT ADVANCING DIFFICULTIES AND SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND CALCIFIED VESSEL. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING PROCEDURE, IT WAS NOTED THAT HIGH RESISTANCE WAS ENCOUNTERED DURING ADVANCING AND SHAFT WAS KINKED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT DETACHMENT/SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910479 ↗
• MalfunctionJun 5, 2019Break; Break

  IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR DILATATION. HOWEVER, DURING PREPARATION, OUTSIDE THE PATIENT, IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT WAS KINKED AND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8672545 ↗
• MalfunctionMay 31, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09MAY2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION, BUT FAILED TO CROSS THE LESION EVEN AFTER SEVERAL ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A COMPLETE SEPARATION OF THE HYPOTUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658660 ↗
• MalfunctionMay 24, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02MAY2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 90% STENOSED, 18X2.5MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8640478 ↗
• MalfunctionMay 20, 2019Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26APR2019. IT WAS REPORTED THAT INFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TWICE TO 18 ATMS; HOWEVER THE BALLOON WAS UNABLE TO BE FULLY DILATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A BURST IN THE BALLOON MATERIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8623556 ↗
• MalfunctionMar 7, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13 FEBRUARY 2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY (LAD), BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 8400993 ↗
• MalfunctionFeb 13, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-JAN-2019. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE 85% IN-STENT RESTENOSED, 15MM IN LENGTH, CONCENTRIC TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE LESION CONTAINED >45 AND <90 DEGREES BEND. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8336138 ↗
• MalfunctionDec 11, 2018Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20 NOV 2018 IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED, 2.75MM X 15MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 2.75MM X 15MM 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'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE MICROSCOPICALLY EXAMINED. THE HYPOTUBE WAS COMPLETELY SEPARATED 82.5CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACES WERE OVALED AND TORN, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THERE ARE NUMEROUS HYPOTUBE KINKS. THE TIP IS DAMAGED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES CONTRIBUTING TO THE REPORTED DIFFICULTY, WHICH COULD NOT BE CONFIRMED BECAUSE THE CLINICAL CIRCUMSTANCES COULD NOT BE REPLICATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8153686 ↗
• MalfunctionDec 11, 2018Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE 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 8151180 ↗
• MalfunctionMay 2, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED DISTAL, MID AND PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION CONTAINED 18 0 DEGREES BEND WITH A CALCIFIED NODULE IN THE MID RCA. A 2.75MM X 15MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS INFLATED THREE TIMES AT THE MAXIMUM PRESSURE OF 22 ATMOSPHERES, THE BALLOON WINGS WAS RAISED/ BULGED AND THEN RUPTURED. THE DEVICE WAS SIMPLY 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 7481845 ↗
• MalfunctionApr 9, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 15MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITH THE GUIDING CATHETER 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 7410212 ↗
• MalfunctionMar 13, 2018Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15-FEB-2018. IT WAS REPORTED THAT SHAFT BREAK OCCURRED LESS THAN 15CM FROM THE HUB. DURING PREPARATION OF A 2.75MM X 15MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER, IT WAS NOTED THAT THE DELIVERY SHAFT WAS FRACTURED LESS THAN 15CM FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE BREAK 42.1CM FROM THE HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333992 ↗

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-0031-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
• Z-0030-04 · Aug 20, 2003 · Terminated
  Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011