ATTAIN CLARITY™ 6225Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169530102), received between Jun 8, 2017 and Aug 25, 2020 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT WHEN THE BALLOON CATHETER WAS BEING TESTED OUTSIDE OF THE BODY, THE BALLOON BURST WHEN AIR WAS BEING INJECTED INTO IT. THE PHYSICIAN NOTED IT WAS ONLY INFLATING ON ONE SIDE. THE BALLOON CATHETER WAS NOT USED AND A DIFFERENT ONE WAS USED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448661 ↗
• MalfunctionMay 20, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON OF THE CATHETER. AFTER MULTIPLE ATTEMPTS THE PHYSICIAN INFLATED THE BALLOON MORE AND WAS EVENTUALLY ABLE TO DEFLATE THE BALLOON. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10077186 ↗
• InjuryFeb 6, 2020Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WAS INFLATED DURING A VENOGRAM PROCEDURE. THE BALLOON WAS ATTEMPTED TO BE REMOVED WITHOUT DEFLATING. WHEN IT WAS NOTED THAT THE BALLOON WAS NOT DEFLATED, IT WAS ATTEMPTED TO BE, BUT WITHOUT SUCCESS. WHEN THE SHEATH WAS PULLED OUT THE BALLOON WAS MISSING AND DISAPPEARED IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9678625 ↗
• MalfunctionJan 14, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CORONARY SINUS APPEARED WITH DYE STAINING AFTER A BALLOON CATHETER WAS USED WITH DYE INJECTION. 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 9588295 ↗
• MalfunctionJan 2, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON CATHETER LUMEN FAILED AND THE BALLOON FILLED WITH CONTRAST. DEFLATION DIFFICULTY WAS ALSO EXPERIENCED AND THE BALLOON EVENTUALLY COLLAPSED INTO THE DELIVERY PLATFORM AND EVERTED UPON REMOVAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9540762 ↗
• MalfunctionNov 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HOOK CATHETER KINKED, CAUSING THE TIP OF THE BALLOON CATHETER TO SNAP OFF. THE PRODUCT WAS REMOVED AND DIFFERENT PRODUCT WAS USED TO COMPLETE 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 9292886 ↗
• MalfunctionOct 9, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER WOULD NOT DEFLATE. 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 9172742 ↗
• MalfunctionApr 22, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WAS DIFFICULTY DEFLATING THE BALLOON CATHETER. THE CATHETER WAS NOT USED. A DIFFERENT CATHETER WAS USED TO COMPLETE 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 8537257 ↗
• MalfunctionApr 17, 2019Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE BALLOON CATHETER WAS DIFFICULT TO INFLATE AND THEN UNABLE TO BE DEFLATED. A LARGER SYRINGE WAS USED TO DEFLATE THE BALLOON AND THE CATHETER WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8523212 ↗
• MalfunctionFeb 5, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE BALLOON CATHETER WAS INFLATED SUCCESSFULLY TWO TIMES, BUT ON THE THIRD ATTEMPT, THE BALLOON WOULD NO HOLD AIR. THE BALLOON CATHETER WAS REPLACED WITH ANOTHER BALLOON CATHETER TO OCCLUDE THE CORONARY SINUS FOR LEFT VENTRICLE VENOGRAM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8307036 ↗
• MalfunctionJun 25, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE BALLOON CATHETER WAS USED ONCE WITH NO ISSUES AND THEN WHEN IT WAS REINSERTED FOR ANOTHER VENOGRAM, THE BALLOON WOULD NOT DEFLATE. THE BALLOON CATHETER AND SHEATH WERE REMOVED TOGETHER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7635480 ↗
• 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, THE CORONARY SINUS DISSECTION OCCURRED WHILE USE OF CATHETER BALLOON. THE CASE WAS STOPPED AND PATIENT WILL HAVE TO COME BACK FOR LEFT VENTRICULAR (LV) LEAD IMPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 7255144 ↗
• MalfunctionFeb 8, 2018Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE BALLOON CATHETER WOULD NOT DEFLATE AFTER CONTRAST WAS INJECTED INTO THE PORT, EVEN WHEN NEGATIVE PRESSURE WAS USED. THE CATHETER AND SHEATH WERE REMOVED TOGETHER, AND THEN THE BALLOON BURST AS IT WAS EXITING THE VEIN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7254092 ↗
• MalfunctionDec 7, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON CATHETER WAS STUCK IN AN INFLATED STATE AND COULD TEMPORARILY NOT BE DEFLATED WHILE IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7094100 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A CORONARY SINUS DISSECTION DUE TO THE BALLOON CATHETER. IT WAS NOTED THE DISSECTION WAS CAUSED BY THE BALLOON TRAUMATIZING THE ENDOTHELIUM DURING THE LEFT VENTRICULAR LEAD IMPLANT, WHICH THEN PROCEEDED TO IMPLANT. THE PATIENT WAS A PARTICIPANT IN THE ATTAIN STABILITY QUAD STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 7093524 ↗
• MalfunctionOct 6, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CONTRAST BECAME TRAPPED IN THE BALLOON CATHETER DURING A VENOGRAM. THE CONTRAST WAS UNABLE TO BE REMOVED AND THE BALLOON CATHETER HAD TO BE REMOVED FROM THE BODY TO GET THE CONTRAST OUT. THE DELIVERY 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 6925418 ↗
• MalfunctionJun 8, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AND AFTER THE CORONARY SINUS VENOGRAM, THE BALLOON CATHETER WOULD NOT DEFLATE. AFTER CONTRAST INJECTION, THE DYE SEEMED TO STAIN THE TIP OF THE BALLOON. IT APPEARED TO BE A BALL OF DYE. DESPITE MULTIPLE EFFORTS, THE BALLOON WOULD NOT DEFLATE. A WIRE WAS DELIVERED THROUGH THE SHEATH TO RETAIN CORONARY SINUS ACCESS AND THE BALLOON CATHETER WAS RETRACTED INTO THE INTRODUCER SHEATH AND FORCED TO CLOSE. THE SYSTEM WAS REMOVED FROM THE BODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6624184 ↗