ATTAINRecalls & reported problems across all models

We found 3 models of ATTAIN by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2017 and Jul 30, 2025 — classified as 10 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ATTAIN problems

ATTAIN models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ATTAIN? 6215

  CATHETER, FLOW DIRECTED
  23 reports
• ATTAIN® 6227DEF04

  CATHETER, PERCUTANEOUS
  18 reports
• Attain™ 6215

  CATHETER, FLOW DIRECTED
  16 reports

Recent ATTAIN adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Adverse 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 HAD A SUSPECTED PERFORATION OF THE CORONARY SINUS RESULTING IN TAMPONADE AND REQUIRED IMMEDIATE MEDICAL TREATMENT. IT WAS NOTED THAT THE CATHETER WAS THE SUSPECTED CAUSE OF THE PERFORATION. PERICARDIOCENTESIS WAS PERFORMED WITH DRAINING OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS STABILIZED AND TAKEN TO THE CORONARY CARE UNIT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Perforation

  MAUDE report 22666871 ↗
• 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 ↗
• MalfunctionSep 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE OF THE DELIVERY CATHETER, THE PHYSICIAN NOTED, THERE IS A NOTABLE DIFFERENCE IN HOW WELL THE SAFESHEATH SEALING ADAPTORS STAY ON THE DELIVERY CATHETER. AFTER THE SECOND SEALING ADAPTOR WAS OPENED, WITH THE SAME ISSUE, THE PHYSICIAN CONTINUED WITH THE CASE BUT NOTED THAT THERE WAS BLOOD LOSS COMPARED TO IF THE ADAPTOR STAYED ON THE DELIVERY CATHETER. THE PHYSICIAN NOTED THAT FOR THE MOST PART, THE ADAPTORS NO LONGER STAY ON THE DELIVERY CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279026 ↗
• 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 ↗
• MalfunctionMay 9, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A STRAND OF HAIR INSIDE THE PACKAGING OF THE INTRODUCER. THE CATHETER INTRODUCER WAS NOT USED AND A REPLACEMENT INTRODUCER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896006 ↗
• 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 ↗
• MalfunctionOct 26, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY SLITTING TWO CATHETERS DURING A PROCEDURE. THE CATHETERS WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697926 ↗
• MalfunctionOct 26, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY SLITTING TWO CATHETERS DURING A PROCEDURE. THE CATHETERS WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697918 ↗

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