ATTAIN? 6215Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00613994842114), received between Feb 9, 2017 and Oct 19, 2020 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (8 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING TESTING, THE BALLOON CATHETER FAILED TO DEFLATE. THE BALLOON CATHETER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10700458 ↗
• MalfunctionAug 25, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE HAD PROBLEMS COMING THROUGH THE BALLOON CATHETER. THE GUIDEWIRE AND BALLOON CATHETER WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451303 ↗
• MalfunctionAug 13, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, TWO VENOGRAM BALLOON CATHETERS WERE INFLATED OUTSIDE OF THE PATIENT¿S BODY TO CHECK IF THEY WERE WORKING PROPERLY. BOTH BALLOON CATHETERS COULD NOT BE DEFLATED. THE BALLOON REMAINED INFLATED AND THE AIR COULD NOT RETURN TO THE SYRINGE. THE BALLOON CATHETERS WERE COVERED WITH THE PATIENT¿S FLUIDS AND WERE DISCARDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10401999 ↗
• MalfunctionAug 11, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT, WHILE PREPARING THE VENOGRAM BALLOON, THE BALLOON DID NOT DEFLATE. THE VENOGRAM BALLOON WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393944 ↗
• MalfunctionJul 24, 2020Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE BALLOON CATHETER WAS TESTED AND DID NOT INFLATE OR DEFLATE PROPERLY. THE CATHETER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320730 ↗
• MalfunctionJul 22, 2020Break; Burst Container or Vessel; Device Contamination with Body Fluid; Activation, Positioning or Separation Problem; Break; Burst Container or Vessel; Device Contamination with Body Fluid; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE BALLOON CATHETER WOULD NOT ALLOW THE CORONARY WIRE TO PASS THROUGH AND EXIT THE CATHETER LUMEN. THE CATHETER WAS NOT USED AND ANOTHER WAS USED. THE CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311045 ↗
• MalfunctionJul 19, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN COULD NOT GET THE WIRE THROUGH THE TIP OF THE BALLOON CATHETER. THE CATHETER WAS USED FOR THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8805911 ↗
• MalfunctionJun 7, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER WAS DEFECTIVE DURING THE HANDLING. THE CATHETER WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8679297 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE BALLOON CATHETER CAUSED A CORONARY SINUS DISSECTION. IT WAS NOTED THAT FLOW WAS MAINTAINED, AND THE PROCEDURE CONTINUED AS PLANNED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 8434012 ↗
• MalfunctionOct 16, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON ON THE CATHETER PROPERLY INFLATED, BUT CONTRAST WAS SHOOTING BACKWARDS INSTEAD OF FORWARD. THE CATHETER WAS USED WITHOUT A BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7969331 ↗
• MalfunctionSep 10, 2018No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, IT WAS NOT POSSIBLE TO PUSH ANY GUIDEWIRE THROUGH THE BALLOON OF THE CATHETER. THE CATHETER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7860927 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS THE PHYSICIAN WAS ATTEMPTING TO PLACE THE GUIDE CATHETER AND BALLOON CATHETER INTO THE CORONARY SINUS, A DISSECTION OCCURRED. A LEFT VENTRICULAR (LV) LEAD WAS NOT PLACED AND THE PATIENT WILL BE EVALUATED AT A LATER DATE FOR A POSSIBLE EPICARDIAL LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 7606555 ↗
• MalfunctionMay 21, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN INDICATED THERE WAS DIFFICULTY INTRODUCING THE GUIDEWIRE INTO THE BALLOON CATHETER. AFTER INTRODUCTION OF THE WIRE INTO THE CATHETER, THE GUIDEWIRE BECAME STUCK AT THE DISTAL END/TIP OF THE BALLOON CATHETER. INTRODUCING THE WIRE BY FRONT LOADING ALLOWED THE WIRE TO PASS IN AND OUT OF THE TIP WITH NO NOTED ISSUE. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7529660 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE ACCESSING THE CORONARY SINUS A CORONARY DISSECTION OCCURRED DUE TO ADVANCEMENT OF A BALLOON TIPPED WEDGE CATHETER. THE CATHETER WAS REMOVED. THE PATIENT WAS OBSERVED OVERNIGHT, HAD AN ECHOCARDIOGRAM, AND CHEST X-RAY WHICH REVEALED THERE WERE NO ABNORMALITIES DUE TO THE DISSECTION. THE PATIENT IS A PARTICIPANT IN THE ADAPTRESPONSE CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 7255615 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHILE UTILIZING THE BALLOON CATHETER, ALONG WITH NOTE OF A PERFORATION AND TAMPONADE FROM THE PERFORATION. THE EFFUSION WAS NOTICED BY THE DISTRIBUTION OF CONTRAST FLUID ON THE FLUOROSCOPIC IMAGING. THE PATIENT HAD SYMPTOMS OF PAIN, ALTHOUGH SEDATED AND THEN OXYGEN SATURATION STARTED TO DROP. THE CATHETER DID NOT SHOW ANY VISIBLE SIGNS OF A DEFECT. THE PHYSICIAN DID NOT ADVANCE THE BALLOON CATHETER BUT RATHER HAD THE CATHETER PULLED BACKWARDS A LITTLE IN ORDER TO HAVE THE BALLOON BEFORE INFLATING IT. THE CORONARY SINUS OF THE PATIENT HAD RELATIVELY SMALL DIAMETER. THERE WERE NO HANDLING ERRORS AND NO INDICATION THE PERFORMANCE OF THE CATHETER LED TO THE EFFUSION. THE DELIVERY CATHETER WAS REMOVED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) DUE TO THE EFFUSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Great Vessel Perforation; Pain; Pericardial Effusion

  MAUDE report 7253611 ↗
• MalfunctionDec 7, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION DIFFICULTY WAS EXPERIENCED WITH THE BALLOON CATHETER. A DIFFERENT BALLOON WAS THEN USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7093712 ↗
• MalfunctionOct 6, 2017Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE BALLOON CATHETER WAS TESTED PRIOR TO USE AND WAS NOTED TO HAVE WATER INSIDE OF IT. A DIFFERENT CATHETER WAS THEN USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6924272 ↗
• MalfunctionAug 9, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WHEN DEFLATING THE BALLOON ON THE CATHETER, THE SYRINGE CAME BACK WITH SOME AIR, HOWEVER THE BALLOON DID NOT DEFLATE COMPLETELY. A NEW BALLOON CATHETER WAS OPENED AND USED WITH NO ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6781885 ↗
• MalfunctionAug 9, 2017Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON CATHETER FAILED TO INFLATE DURING A PRE-USE CHECK AND THE BALLOON CATHETER WAS NOT IMPLANTED INTO THE PATIENT'S VASCULATURE SYSTEM. THE BALLOON CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6781126 ↗
• MalfunctionApr 6, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE BALLOON CATHETER WAS INSERTED INTO THE CORONARY SINUS AND AS THE PHYSICIAN ATTEMPTED TO INSERT A GUIDEWIRE INTO THE BALLOON CATHETER, IT WAS NOT POSSIBLE TO ENTER THE LUMEN OF THE BALLOON CATHETER MORE THAN A FEW CENTIMETERS. THE BALLOON CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6470395 ↗
• MalfunctionApr 6, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE DILATOR INTO THE DELIVERY CATHETER. IT WAS NOTED THERE WAS HIGH FRICTION WITHIN THE CATHETER, WHICH MADE IT DIFFICULT TO ADVANCE THE DILATOR. LATER IN THE PROCEDURE, IT WAS ALSO DIFFICULT TO ADVANCE THE LEAD WITHIN THE CATHETER. THE DELIVERY CATHETER WAS REPLACED TO COMPLETE THE IMPLANT PROCEDURE. IT WAS ALSO ADDED THAT WHILE PREPARING THE BALLOON CATHETER ON THE TABLE, THE BALLOON DID NOT DEFLATE AFTER INFLATION. IT WAS NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6467329 ↗
• MalfunctionFeb 9, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE VENOGRAM BALLOON CATHETER DID NOT INFLATE COMPLETELY. THE CATHETER ALSO DID NOT DEFLATE COMPLETELY. THE CATHETER WAS NOT USED AND WAS REPLACED WITH A NEW BALLOON CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6321030 ↗
• InjuryFeb 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A VASCULAR DISSECTION OCCURRED WHILE IMPLANTING THE DELIVERY CATHETER, WHICH CAUSED VESSEL EDEMA AND DIFFICULTY TO IMPLANT THE LEFT VENTRICULAR (LV) LEAD. THE DELIVERY CATHETER WAS REPLACED AND AFTER THE LV LEAD REACHED THE TARGET POSITION, THE LEAD DISLODGED DURING SLITTING OF THE DELIVERY CATHETER. THE PHYSICIAN REPLACED THE DELIVERY CATHETER AGAIN TO RE-IMPLANT THE LV LEAD, BUT THE LEAD DISLODGED AGAIN. IT WAS NOTED DUE TO PATIENT'S VASCULAR DISSECTION AND POOR CARDIAC FUNCTION, THE LV LEAD WOULD NOT BE IMPLANTED; THE PHYSICIAN CHOSE TO IMPLANT A SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Edema; Vascular Dissection

  MAUDE report 6317235 ↗