Quantum™ Maverick™ H7493808008300Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08714729392569), received between Jan 9, 2017 and Aug 13, 2025 — classified as 1 injury, 33 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Break; Deformation Due to Compressive Stress; Material Deformation; Break; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 8MM QUANTUM? MAVERICK? BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE DEVICE FRACTURED AT THE WELD INTERFACE WHEN BEING PUSHED. THE DEVICE WAS REMOVED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22800675 ↗
• MalfunctionJul 15, 2024Break; Inflation Problem; Material Deformation; Break; Inflation Problem; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON FAILED TO INFLATE, AND IT WAS OBSERVED THAT THE CATHETER WAS KINKED AND BENT. UPON REMOVAL OF THE DEVICE, THE CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19743938 ↗
• MalfunctionMar 6, 2024Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29FEB2024. IT WAS REPORTED THAT A BALLOON INFLATION FAILURE OCCURRED. THE 80% STENOSED, 3.0 X 12MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, WHILE INSIDE THE PATIENT, THE PRESSURE WAS NOT SUFFICIENT AND COULD NOT PROVIDE ENOUGH SUPPORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED HYPOTUBE DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848195 ↗
• MalfunctionFeb 1, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AFTER UNPACKING OF A 3.0MM X 8MM, QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE CATHETER WAS BROKEN INTO TWO PIECES. A NEW CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621663 ↗
• MalfunctionNov 21, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE SHAFT WAS KINKED AND WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180665 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED NORMALLY FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597481 ↗
• MalfunctionJun 2, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED, HOWEVER, THE BALLOON FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED NAD THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11924778 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE DEVICE WAS ADVANCED HALFWAY IN THE GUIDING CATHETER, THE SHAFT BROKE IN TWO PIECES AT 55CM FROM THE HUB. THE FRACTURED PART WAS COMPLETELY RETRIEVED THROUGH THE GUIDING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607492 ↗
• MalfunctionMar 23, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING UNPACKING OF A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE DELIVERY SHAFT WAS FRACTURED NEAR THE BALLOON AND WAS SEPARATED IN TWO PIECES. 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 11557764 ↗
• MalfunctionMar 16, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25FEB2021. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED; HOWEVER, THE DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495125 ↗
• MalfunctionSep 21, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 81% STENOSED, 30MM X 3.0MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE BALLOON DELIVERY SHAFT WAS FRACTURED AT 20CM FROM THE DISTAL END OF THE BALLOON. THE DEVICE WAS SIMPLY PULLED OUT AND COMPLETELY RMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER INITIALLY REPORTED AND CORRECT DEVICE SHOULD HAVE BEEN A 2.50MM X 15MM MAVERICK BALLOON CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10559987 ↗
• MalfunctionJun 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT CIRCUMFLEX CORONARY ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED 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 10140396 ↗
• MalfunctionJun 3, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS UNPACKED, HOWEVER; THE BALLOON WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THIS WAS NOT USED INSIDE THE PATIENT'S BODY.

  Patient problems: No Patient Involvement

  MAUDE report 10115638 ↗
• MalfunctionNov 19, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED, 10MMX3.0MM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9344286 ↗
• MalfunctionOct 11, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING PREPARATION OF A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE SHAFT WAS FRACTURED IN THE MIDDLE OF THE STENT DELIVERY SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9180140 ↗
• MalfunctionOct 3, 2019Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE DISTAL END OF THE LESION BY A GUIDEZILLA GUIDE EXTENSION CATHETER. HOWEVER, IT WAS NOTED THAT THE BALLOON COULD NOT BE FILLED NORMALLY AND THE CONTRAST AGENT WAS FOUND TO BE LEAKING. THE BALLOON WAS DAMAGED AND A VISIBLE PINHOLE WAS NOTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152015 ↗
• MalfunctionJun 25, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 85% STENOSED, 20X3.0MM, ECCENTRIC, DE NOVO TARGET LESION WITH A BEND OF MORE THAN OR EQUAL TO 90 DEGREES WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED MID RIGHT CORONARY ARTERY. AFTER CROSSING A GUIDE WIRE, A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION BUT THE DEVICE 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 FRACTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8732905 ↗
• MalfunctionJun 7, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION 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 WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SEPARATED HYPOTUBE. IT WAS FURTHER REPORTED THAT WHEN THE DEVICE WAS ATTEMPTED TO CROSS THE LESION, THE SHAFT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679236 ↗
• MalfunctionMay 17, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25-APR-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 3.0MM X 8MM 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 DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619376 ↗
• MalfunctionJan 11, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED, 18X2.75MM, TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SERIOUSLY CALCIFIED LEFT CIRCUMFLEX CORONARY ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTICED THAT THE SHAFT OF THE STENT WAS FRACTURED 60 CENTIMETERS AWAY FROM THE DISTAL END. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8241170 ↗
• MalfunctionJan 11, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20-DEC-2018. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED, 12MMX 3.0MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8240724 ↗
• MalfunctionOct 31, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED, 2.75X20MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. 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'S STATUS WAS STABLE. RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED NO DAMAGES. MICROSCOPIC EXAMINATION REVEALED A LONGITUDINAL TEAR 8MM FROM THE TIP APPROXIMATELY 10MM LONG. THERE IS BLOOD PRESENT IN THE INFLATION LUMEN, GUIDEWIRE LUMEN, AND BALLOON. THE BALLOON IS LOOSELY FOLDED. THE REPORTED INFORMATION INDICATES THE DEVICE WAS INFLATED TO 18ATM; THEREFORE, THERE IS NO INDICATION THE DEVICE WAS INFLATED OVER RBP. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025658 ↗
• MalfunctionOct 12, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE ECCENTRIC TARGET LESION WITH A BEND OF BETWEEN 45 AND 90 DEGREES WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON, THE BALLOON RUPTURED. DILATATION WAS THEN PERFORMED WITH ANOTHER BALLOON AND AFTER MULTIPLE INFLATIONS, A STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7961036 ↗
• MalfunctionSep 18, 2018Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE BALLOON DELIVERY SHAFT GOT FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT'S COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886945 ↗
• MalfunctionJul 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 93% STENOSED, 8.00MM IN LENGTH TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, CALCIFIED AND 3.00MM IN DIAMETER LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7732005 ↗

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