Attain™ 6215Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000227982), received between Aug 31, 2020 and Jan 27, 2025 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PATIENT EXPERIENCED A TAMPONADE DUE TO PERFORATION AND DISSECTION OF THE CORONARY SINUS. DURING THE IMPLANT THE CATHETER AND GUIDE CATHETER WERE INSERTED INTO THE CORONARY SINUS, FOLLOWED BY THE BALLOON CATHETER. THE BALLOON CATHETER WAS INFLATED. THE PATIENT THEN EXPERIENCED CHEST DISCOMFORT AND AN ECHOCARDIOGRAM WAS IMMEDIATELY PERFORMED. A SIGNIFICANT DROP IN BLOOD PRESSURE WAS OBSERVED AND A TAMPONADE WAS DETECTED. THE CATHETER, GUIDE CATHETER, AND BALLOON CATHETER WERE REMOVED AND THE PATIENT UNDERWENT MEDICAL AND SURGICAL INTERVENTION. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED WITH A PERICARDIAL PUNCTURE TO TREAT THE TAMPONADE.

  Patient problems: Cardiac Tamponade; Discomfort; Low Blood Pressure/ Hypotension; Perforation; Vascular Dissection

  MAUDE report 21244564 ↗
• MalfunctionJul 9, 2024

  BALLOON ON CATHETER WOULD NOT PASSIVELY DEFLATE WHILE BEING TESTED PRIOR TO INSERTING INTO BODY. THE CATHETER WAS REPLACED WITH ANOTHER AND THERE WERE NO FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19700124 ↗
• MalfunctionApr 10, 2024Difficult to Insert; Difficult to Insert

  IT WAS FURTHER REPORTED THAT THE EVENT OCCURRED PRIOR TO THE CATHETER BEING INSERTED INTO THE PATIENT¿S BODY. THE CATHETER TESTING WAS CONDUCTED ON THE SURGICAL TABLE ALONGSIDE OTHER OPERATING TOOLS AND INSTRUMENTS. THE PHYSICIAN WAS SPRAYED WITH THE SYRINGE¿S CONTENTS WHICH WAS SALINE; HOWEVER, BODILY FLUIDS WERE SURROUNDING THE WORKING ENVIRONMENT AND COULD HAVE CROSS CONTAMINATED. DETAILS WERE CONFIRMED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077709 ↗
• MalfunctionJul 21, 2023Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE AND WHEN TESTING THE CATHETER AFTER OPENING, A BALLOON MALFUNCTION WAS DETECTED. A LOOSE/DETACHED PART WAS NOTED AND THE BALLOON WOULD NOT INFLATE TO THE CORRECT PRESSURE. THE CATHETER WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374895 ↗
• MalfunctionMar 21, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING USE OF THE BALLOON CATHETER, THE BALLOON DID NOT DEFLATE AFTER INFLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582623 ↗
• MalfunctionDec 20, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON CATHETER WAS UNABLE TO DEFLATE DURING THE IMPLANT PROCEDURE. A NEW BALLOON WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019671 ↗
• MalfunctionAug 5, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER WAS TESTED ON THE TROLLEY IN THE CATH LAB AND SOME DIFFICULTY IN INFLATION WAS EXPERIENCED. THE BALLOON CATHETER DID NOT INFLATE ONCE IN THE CORONARY SINUS AND IT WAS TAKEN OUT. IT WAS THEN TESTED AGAIN ON THE TABLE AND THE BALLOON CATHETER WAS DIFFICULT TO INFLATE AGAIN AND THEN WOULD NOT DEFLATE. THE BALLOON CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15175993 ↗
• MalfunctionFeb 10, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION OF THE BALLOON DELIVERY CATHETER, A HOLE WAS NOTED IN THE BALLOON. THE DELIVERY CATHETER WAS NOT UTILIZED AND REPLACED. THE BALLOON DELIVERY CATHETER WAS RETURNED TO THE MANUFACTURER AFTER BEING REPLACED. THE BALLOON DELIVER CATHETER WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506452 ↗
• MalfunctionJan 13, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING TESTING THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN MANUALLY DEFLATED THE BALLOON WITH THEIR HAND. ANOTHER INFLATE WAS TRIED AND, AGAIN, THE BALLOON CATHETER WOULD NOT DEFLATE. THE BALLOON CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252589 ↗
• MalfunctionDec 7, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE BALLOON CATHETER DID NOT APPEAR TO HOLD THE AIR WELL ENOUGH TO MAINTAIN BALLOON PRESSURE. THE BALLOON CATHETER WAS SUBMERGED IN A SALINE SOLUTION AND A BREACH IN THE BALLOON WAS OBSERVED. THE BALLOON WAS NOT USED AND A REPLACEMENT BALLOON WAS USED WITH NO ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12952898 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MINI EFFUSION AND DISSECTION DURING AN IMPLANT PROCEDURE WHILE USING THE BALLOON CATHETER. THERE WERE NO ACTIONS TAKEN AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 12391721 ↗
• MalfunctionApr 19, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER INITIALLY HAD DIFFICULTY INFLATING THE BALLOON, THEN AFTER IT WAS DEPLOYED, BUT THE BALLOON NO LONGER WANTED TO DEFLATE. THE CATHETER WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11688319 ↗
• MalfunctionApr 8, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE BALLOON CATHETER WAS TESTED PRE-INSERTION WITH NO LEAK NOTED AND THE FIRST INFLATION WAS SUCCESSFUL. WHEN THE SECOND INFLATION WAS ATTEMPTED THERE WAS NO INFLATION. THE BALLOON CATHETER WAS REMOVED FROM THE BODY, TESTED IN SALINE AND AN AIR LEAK WAS NOTED. ANOTHER CATHETER WAS USED TO COMPLETE THE IMPLANT PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634930 ↗
• MalfunctionOct 16, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHILE PERFORMING A CORONARY SINUS VENOGRAM, THE BALLOON CATHETER WAS UNABLE TO DEFLATE. THE PHYSICIAN ADVANCED A DEFLECTABLE CATHETER OVER THE BALLOON AND DEFLATED THE BALLOON. ONCE OUTSIDE OF THE PATIENT, THE BALLOON INFLATED AND DEFLATED AS EXPECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10688193 ↗
• InjurySep 1, 2020Adverse 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 THAT COINCIDED CLOSELY IN TIME AND LOCATION WITH THE BALLOON INFLATION. THE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS ABANDONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 10478498 ↗
• MalfunctionAug 31, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON CATHETER WOULD NOT DEFLATE DURING TESTING PRIOR TO USE. THE PRODUCT WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10474330 ↗