Quantum™ Maverick™ H7493808012250Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 08714729392651), received between Jan 18, 2017 and May 12, 2025 — classified as 1 death, 1 injury, 55 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 57 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.5MM UNKNOWN STENT WAS DEPLOYED, AND A 2.5 MM X 12 MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS THEN INFLATED TO 12 ATMOSPHERES FOR POST-DILATION WITHIN THE STENT AND WAS DEFLATED FOR 8 SECONDS BEFORE ATTEMPTING WITHDRAWAL. HOWEVER, AFTER RETRACTING THE PRESSURE PUMP, IT WAS NOTED THAT A CONTRAST AGENT HAD ACCUMULATED IN THE BALLOON AND COULD NOT BE RETRACTED. THE BALLOON WAS WITHDRAWN USING AN EXTENSION CATHETER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT IT WAS CONFIRMED VIA FLUOROSCOPY THAT THE BALLOON DID NOT DEFLATE COMPLETELY. THE PATIENT EXPERIENCED CHEST PAIN AND A DECREASE IN BLOOD PRESSURE.

  Patient problems: Chest Pain; Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005719 ↗
• MalfunctionNov 29, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) UNDER LOCAL ANESTHESIA. AFTER IMPLANTATION OF CORONARY STENT, A HIGH-PRESSURE BALLOON WAS PLANNED, AND A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, AFTER OPENING THE PACKAGE, IT WAS NOTED THAT THE SHAFT BROKE AROUND THE MIDDLE OF DELIVERY ROD AND COULD NOT BE USED NORMALLY. THE PHYSICIAN REPLACED THE BALLOON IMMEDIATELY TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876661 ↗
• MalfunctionJun 16, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT CORONARY STENTING PROCEDURE. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IN THE PROCESS OF ADVANCING THE BALLOON INTO THE GUIDE CATHETER, IT WAS FOUND THAT THE BALLOON WAS BROKEN IN THE MIDDLE PART, AND THE BROKEN POSITION WAS ABOUT 40 CM AWAY FROM THE HEAD. THE DEVICE WAS REMOVED DIRECTLY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14715977 ↗
• MalfunctionJun 2, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT LABELING ISSUE OCCURRED. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, THE OUTER PACKAGE, INNER PACKAGE AND INNER SHAFT OF THE BALLOON, DID NOT MATCH THE MODEL. THE SIZE ON THE OUTER PACKAGE WAS 2.5MM X 12MM, AND THE SIZE OF THE INNER PACKAGE IS 2.75MM X 12MM, BUT THE SIZE ON THE DELIVERY SHAFT IS STILL 2.5MM X 12MM. ANOTHER QUANTUM MAVERICK BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14578132 ↗
• MalfunctionApr 20, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT LABELING ISSUE OCCURRED. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE SPECIFICATION AND BATCH NUMBER ON THE INNER PACKAGE WERE DIFFERENT FROM WHAT WAS INDICATED ON THE OUTER PACKAGE. 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 14164171 ↗
• MalfunctionAug 9, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE BALLOON WAS FOUND 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 12295348 ↗
• MalfunctionJun 25, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE DELIVERY SHAFT FRACTURED INTO TWO PIECES. THE DEVICE WAS REMOVED DIRECTLY, AND NO PORTION WAS LEFT IN THE PATIENT. 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 12064732 ↗
• MalfunctionMay 6, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER THE DEVICE WAS UNPACKED, THE ADVANCING SHAFT HAD A SLIGHT CREASE WHICH BROKE 80 CM FROM THE HUB WHEN IT WAS PUSHED TO THE GUIDE CATHETER. THE DEVICE WAS REMOVED FROM THE GUIDE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788253 ↗
• MalfunctionApr 28, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13APR2021. IT WAS REPORTED THAT SHAFT KINK OCCURED. THE 93% STENOSED, 14MM IN LENGTH TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED, 2.5MM IN DIAMETER LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT WAS KINKED 85CM AWAY FROM THE DISTAL END OF THE HUB. 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 COMPLETE SEPARATION AT 86.6CM DISTAL OF THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738721 ↗
• MalfunctionFeb 16, 2021Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-JAN-2021. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE OCCLUDED TARGET LESION WAS LOCATED IN THE MIDDLE OF RIGHT CORONARY ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION BUT THE DEVICE WAS UNABLE TO INFLATE. 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. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335509 ↗
• MalfunctionJan 11, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS FOUND THAT THE SHAFT WAS 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 Consequences Or Impact To Patient

  MAUDE report 11148351 ↗
• MalfunctionDec 22, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16DEC2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 93% STENOSED, 13MMX2.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR USE. HOWEVER, DURING PROCEDURE, THE SHAFT WAS KINKED AT 70CM FROM THE PHYSICIAN'S HAND. 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 SHAFT DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11055940 ↗
• MalfunctionNov 25, 2020Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR POST DILATATION. HOWEVER, RESISTANCE WAS FELT WHEN THE DEVICE WAS ADVANCED THROUGH THE GUIDE. THE DEVICE WAS COMPLETELY REMOVED AND FOUND THAT THE SHAFT WAS BROKE 31 CENTIMETERS FROM THE HUB. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10901851 ↗
• MalfunctionNov 23, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03NOV2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION BUT THE DELIVERY SHAFT WAS NOTED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENTS STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10886337 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FROM DILATATION. HOWEVER, DURING PROCEDURE, THE CATHETER WAS FRACTURED OUTSIDE THE INTERVENTIONAL VESSEL, 64CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED DIRECTLY FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10848151 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR USE; HOWEVER, DURING PROCEDURE, THE DEVICE WAS FRACTURED. 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 10846429 ↗
• MalfunctionSep 23, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS USED; HOWEVER, THE BALLOON SHAFT WAS FRACTURED OUTSIDE THE PATIENT. THE DEVICE WAS WITHDRAWN FROM THE 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 10575687 ↗
• MalfunctionAug 12, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22JUL2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 93% STENOSED, 13MMX2.5MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED; HOWEVER, THE BALLOON DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10398314 ↗
• MalfunctionJul 2, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL END OF THE LEFT CIRCUMFLEX ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, DURING PROCEDURE, THE DELIVERY SHAFT WAS FRACTURED FROM THE MIDDLE TO DISTAL END. THE DEVICE WAS COMPLETELY REMOVED WITHOUT PROBLEM. 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 10224492 ↗
• MalfunctionJun 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED, TARGET LESION WAS LOCATED IN THE PROXIMAL AND MIDDLE OF RIGHT CORONARY ARTERY. ON (B)(6), GUIDE WIRE WERE CROSSED THE LESION, PRE-DILATATION WAS PERFORMED WITH A 2X15MM NON-BSC BALLOON CATHETER BUT COULD NOT BE IMPLANTED DUE TO CALCIFIED LESION. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR TREATMENT. HOWEVER, DURING INFLATION AT 14 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10215048 ↗
• MalfunctionJun 24, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TAGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER STENT IMPLANTATION, A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE SHAFT WAS FRACTURED 30-40CM FROM THE HUB. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INTERVENTION 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 10190133 ↗
• MalfunctionJun 10, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16 MAY 2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE SHAFT WAS KINKED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/ SEPARATED.

  Patient problems: No Patient Involvement

  MAUDE report 10140285 ↗
• MalfunctionJan 29, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JAN2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 92% STENOSED, 14MMX2.4MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE BALLOON DELIVERY SHAFT WAS KINKED. 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 HYPOTUBE SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9643454 ↗
• MalfunctionJul 31, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. DURING UNPACKING OF A 2.5 MM X 12 MM QUANTUM MAVERICK BALLOON CATHETER, IT WAS NOTED THAT THE SHAFT WAS KINKED. 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 DETACHMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8848675 ↗
• MalfunctionJul 15, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JUN2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 2.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE DELIVERY SHAFT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED THAT THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SEPARATED PATIENT'S.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8789957 ↗

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-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