Apex™ H7493895912200Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729475477), received between Jan 26, 2017 and Sep 30, 2022 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED VIA MAUDE REPORT MW5111784 THAT SHAFT BREAK OCCURRED. A 2.00MM X 12MM APEX BALLOON CATHETER WAS ADVANCED FOR USE. THE APEX BALLOON CATHETER WAS INSERTED. A KINKED WAS OBSERVED AND THE APEX BALLOON CATHETER BROKE WHEN IT WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510957 ↗
• MalfunctionAug 5, 2022Material Twisted/Bent

  UPPER 70¿S MALE WITH HISTORY OF HYPERTENSION AND RECENT CHEST PAIN. PROCEDURE: LEFT HEART CATH AND STENT TO LEFT ANTERIOR DESCENDING (LAD). WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, THE BALLOON WAS BENT. NOT USED ON PATIENT. NEW DEVICE OBTAINED WITHOUT COMPLICATIONS. MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, APEX¿ (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174213 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN, LEFT ANTERIOR DESCENDING AND CIRCUMFLEX ARTERIES. A 3.50 X 32 SYNERGY DRUG-ELUTING STENT AND A 2.00MM X 12MM APEX BALLOON CATHETER WERE ADVANCED FOR USE. HOWEVER, DURING PROCEDURE, THE SHAFTS BROKE OUTSIDE OF THE BODY. THE DEVICES WERE COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11651629 ↗
• MalfunctionOct 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM X 12MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE TECH PULLED ANOTHER NEGATIVE PRESSURE BEFORE GOING UP WITH THE BALLOON AND WHEN THE NEGATIVE WAS PULLED, THERE WAS BLOOD PRESENT IN THE INDEFLATOR INDICATING THAT THE BALLOON RUPTURED BEFORE IT WAS INFLATED. THE DEFECTIVE BALLOON WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10684706 ↗
• MalfunctionJul 2, 2020Difficult to Remove; Difficult to Remove

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12JUN2020. IT WAS REPORTED THAT STYLET REMOVAL DIFFICULTIES WERE ENCOUNTERED. DURING UNPACKING OF A 2.00MM X 12MM APEX BALLOON CATHETER, IT WAS NOTED THAT THE TIP OF THE STYLET WAS DAMAGED AND THERE WAS DIFFICULTY IN REMOVING IT. A NEW BALLOON WAS USED AND THE PROCEDURE WAS COMPLETED. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT SEPARATION.

  Patient problems: No Patient Involvement

  MAUDE report 10224750 ↗
• MalfunctionJan 23, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON IT WAS REPORTED THAT INFLATION FAILURE AND LEAK OCCURRED. A 2.00MM X 12MM APEX BALLOON CATHETER WERE ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION THAT REACHED 8 ATMOSPHERES, IT WAS NOTED THAT IT WAS NOT HOLDING AIR AND SEEMS TO HAVE A LEAK. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270087 ↗
• MalfunctionAug 16, 2018Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27JUL2018. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. DURING PREPARATION OF A 2.00MM X 12MM APEX¿ BALLOON CATHETER, IT WAS NOTED THAT THE BALLOON WAS LEAKING GAS AND COULD NOT FULLY EXPAND. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.00MM X 12MM APEX¿ BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS BALLOON TORN CIRCUMFERENTIALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7789823 ↗
• InjuryMar 21, 2018Detachment Of Device Component; Difficult to Remove; Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED CAROTID ARTERY. AFTER A NON-BSC FILTER WIRE WAS UNABLE TO CROSS THE LESION, A 2.00 MM X 12 MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AFTER DILATION WAS PERFORMED, WHEN THE PHYSICIAN WENT TO PULL THE BALLOON OUT OF THE BODY, HE WAS NOT ABLE TO RETRACT IT. EVENTUALLY, HE WAS ABLE TO GET THE BALLOON SHAFT BACK. WHEN FLUOROSCOPY WAS PERFORMED, IT WAS NOTED THAT THE BALLOON MARKER WAS STILL IN THE CAROTID ARTERY. THE DETACHED BALLOON WAS RETRIEVED WITH A 10 MM SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7358334 ↗
• MalfunctionNov 22, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.00MM X 12MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7053205 ↗
• MalfunctionJun 26, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.00MM X 12MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED BELOW THE RECOMMENDED PRESSURE. IT WAS NOTED TO BE DAMAGED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6666476 ↗
• MalfunctionApr 21, 2017Hole In Material; Device Damaged Prior to Use; Hole In Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. A 2.00MM X 12MM APEX BALLOON CATHETER WAS SELECTED FOR USE TO DILATE A LESION. HOWEVER, WHEN THE BALLOON WAS FLUSHED AND PREPPED, IT WAS FELT THAT THE BALLOON MATERIAL WAS COMPROMISED AND A PINHOLE WAS NOTED. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6511278 ↗
• MalfunctionJan 26, 2017Hole In Material; Hole In Material

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00 MM X 12 MM APEX BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. HOWEVER, UPON INFLATION OF ABOUT 3-4 TIMES AT 20 ATMOSPHERES, THE BALLOON WAS UNABLE TO INFLATE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. HOWEVER, A PINHOLE WAS NOTED ON THE BALLOON. 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 6280572 ↗

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