ATTAIN® 6227DEF04Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00613994450753), received between Feb 9, 2017 and Jul 30, 2025 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (12 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 18 most recent of 18 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 23, 2021Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS DIFFICULT TO SLIT AND IT WAS REALIZED THAT THE DEFLECTION WIRE HAD SEPARATED/DETACHED FROM THE SHEATH. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353972 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO CANNULATE THE CORONARY SINUS, THE GUIDE WIRE FROM THE CATHETER SET WAS INSERTED AND THE GUIDE WIRE TOOK A PATH THAT APPEARED TO BE THROUGH THE CORONARY SINUS. THE PHYSICIAN THOUGHT THE PATH DID NOT LOOK CORRECT BUT TRACKED THE GUIDE CATHETER OVER THE GUIDE WIRE. A BALLOON CATHETER WAS INSERTED TO THE END OF THE GUIDE CATHETER AND CONTRAST WAS INJECTED. AT THIS POINT, IT WAS NOTED THAT THE CONTRAST WAS IN THE PERICARDIAL SPACE. THE PHYSICIAN REMOVED THE BALLOON CATHETER AND PULLED BACK THE GUIDE CATHETER. THE GUIDE WIRE WAS THEN RE-INSERTED INTO THE GUIDE CATHETER AND THE CORONARY SINUS WAS CANNULATED. THE PROCEDURE PROCEEDED WITHOUT INCIDENT AND WAS SUCCESSFULLY COMPLETED. AN ECHO CARDIOGRAM WAS PERFORMED POST-OP AND THERE WAS NO EFFUSION NOTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE PROCEDURE AND NO FURTHER ACTION WAS TAKEN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 11732359 ↗
• MalfunctionFeb 4, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER SHEATH DID NOT SLIT ALL THE WAY AND SCISSORS HAD TO BE USED TO COMPLETE THE SLITTING OF THE SHEATH. 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 9664305 ↗
• MalfunctionDec 5, 2019Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER WAS BEING USED WITH A COMPETITIVE SYSTEM AND THE PHYSICIAN HAD TREMENDOUS DIFFICULTY SLITTING THE CATHETER. WHEN THE SLITTING WAS FINALLY COMPLETED, IT WAS NOTED THAT THE CATHETER HAD FRAYED AND EXPOSED WIRES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9418273 ↗
• MalfunctionFeb 20, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A HAIR WAS FOUND IN THE PACKAGING OF THE DELIVERY CATHETER. THE CATHETER WAS NOT USED AND REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8353635 ↗
• MalfunctionFeb 8, 2019Material Fragmentation; Detachment of Device or Device Component; Material Integrity Problem; Material Fragmentation; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER BROKE APART WHEN SLITTING. SUBSEQUENTLY, ANOTHER CATHETER WAS USED, AND THE SAME ISSUE HAPPENED. IT WAS NOTED THAT THE BLADE FROM THE SLITTER WAS DEFECTIVE. THE CATHETER WAS REPLACED, AND ANOTHER SLITTER WAS USED, WHICH WORKED CORRECT, BUT THE PHYSICIAN DECIDED TO USE A SCALPEL AND KELLY CLIP TO CUT THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8321878 ↗
• MalfunctionDec 7, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PROBLEM OCCURRED DURING SLITTING OF THE CATHETER. IT WAS FURTHER REPORTED THAT DURING SLITTING OF THE DEFLECTABLE CATHETER, THE SLITTING BLADE ENCOUNTERED A WIRE. THE PHYSICIAN STOPPED MID-SLIT, MADE ADJUSTMENTS AND CONTINUED SLITTING WITHOUT COMPLICATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8142525 ↗
• MalfunctionDec 7, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PROBLEM OCCURRED DURING SLITTING OF THE CATHETER. DURING SLITTING OF THE DEFLECTABLE CATHETER, THE SLITTING BLADE ENCOUNTERED A WIRE. THE PHYSICIAN STOPPED DURING SLITTING, MADE AN ADJUSTMENT AND COMPLETED THE SLIT WITHOUT COMPLICATIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8142355 ↗
• MalfunctionJun 19, 2018Break; Break

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE CATHETER BROKE MIDWAY DOWN AND COMPLETELY (360 DEGREES AROUND.) THE CATHETER WAS CUT WITH SCISSORS. A SECOND CATHETER WAS TRIED, BUT THE SAME ISSUE OCCURRED AND ADDITIONALLY THE DEFLECTABLE WIRE CAME OUT WHILE THE CATHETER WAS BEING SLIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7616084 ↗
• MalfunctionJun 8, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED BY THE PHYSICIAN THAT DURING THE IMPLANT PROCEDURE, THE SLITTER CAUGHT ON THE RADIOPAQUE MARKER OF THE DELIVERY CATHETER AND WOULD NOT SLIT. THE PHYSICIAN HAD TO CUT OFF THE REMAINING PORTION OF THE CATHETER MANUALLY. THE DELIVERY 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 6628577 ↗
• MalfunctionJun 8, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHILE SLITTING THE DELIVERY CATHETER DURING IMPLANT, THE PHYSICIAN GOT SNAGGED AT THE DISTAL PORTION OF THE CATHETER AND IT PULLED THE LEFT VENTRICULAR (LV) LEAD FROM THE CORONARY SINUS. IT WAS NOTED THE SNAG APPEARED TO BE ON THE WIRE FOR DEFLECTION PORTION. THE DELIVERY CATHETER WAS REPLACED TO GAIN CS ACCESS A SECOND TIME AND THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6626788 ↗
• MalfunctionApr 6, 2017Defective Device; Material Integrity Problem; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN HAD RESISTANCE ADVANCING THE DILATOR AND THE CATHETER OVER THE GUIDEWIRE; IT WAS VERY TIGHT IN THE CLAVICLE AREA. UPON RETHREADING THE GUIDEWIRE INTO THE DILATOR, THE CATHETER DID NOT FIT AS SNUGLY AROUND THE DILATOR. ALSO, THE PHYSICIAN HAD TROUBLE SLITTING THE CATHETER. NEAR THE TIP OF THE CATHETER, THE SLITTER CAUGHT ON THE WIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6466727 ↗
• MalfunctionFeb 9, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE CATHETER WAS NOT ABLE TO BE SLIT ALL THE WAY TO THE END. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6316483 ↗