NA EP003994SRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00613994663146), received between Feb 9, 2017 and Jun 20, 2024 — classified as 5 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (51 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE COULD NOT ADVANCE AND TORE THROUGH THE DILATOR. THE NEEDLE AND DILATOR WERE REMOVED FROM THE PATIENT AND WERE FLUSHED. A SMALL PIECE OF PLASTIC CAME FROM THE INSIDE OF THE DILATOR. THE NEEDLE AND SHEATH WERE REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574338 ↗
• MalfunctionDec 1, 2023Break; Break

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, THE NEEDLE ALONG WITH THE NEEDLE WIRE WAS INSERTED THROUGH THE SHEATH TO ENSURE PROPER FUNCTION. THE NEEDLE WAS RETRACTED AND A SCRATCH ON THE INNER TUBE OF THE SHEATH WAS OBSERVED. IT WAS NOTED THAT THE NEEDLE SCRATCHED THE SHEATH. THE SHEATH WAS REPLACED AND THE NEEDLE WAS CLEANED. WHEN PREPARING THE NEW SHEATH AND NEEDLE, THE NEEDLE (WITH THE NEEDLE WIRE) WAS INSERTED INTO THE SHEATH DILATOR TO CHECK PROPER FUNCTION. WHEN THE NEEDLE GOT RETRACTED, IT WAS OBSERVED THAT THE NEEDLE HAD SCRATCHED THE INNER TUBE OF THE SHEATH. ADDITIONALLY, THERE WAS VISIBLE INNER DEFORMATION IN THE DISTAL TIP OF THE DILATOR. THE SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE. THE NEEDLE WAS CLEANED TO REMOVE THE PLASTIC. WHEN ATTEMPTING THE TRANSSEPTAL PUNCTURE, THE NEEDLE WAS NOT ABLE TO BE ADVANCED. IT WAS NOTED THAT SOMETHING WAS BLOCKING IT. THE NEEDLE AND THE SHEATH WERE RETRACTED AND VISUAL INSPECTION INDICATED THAT THE TIP OF THE DILATOR WAS DEFORMED AND THE TIP OF THE NEEDLE HAD PLASTIC RESIDUE ON IT. THE OUTCOME OF THIS CASE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18249461 ↗
• MalfunctionDec 1, 2023Break; Break

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, THE NEEDLE ALONG WITH THE NEEDLE WIRE WAS INSERTED THROUGH THE SHEATH TO ENSURE PROPER FUNCTION. THE NEEDLE WAS RETRACTED AND A SCRATCH ON THE INNER TUBE OF THE SHEATH WAS OBSERVED. IT WAS NOTED THAT THE NEEDLE SCRATCHED THE SHEATH. THE SHEATH WAS REPLACED AND THE NEEDLE WAS CLEANED. WHEN PREPARING THE NEW SHEATH AND NEEDLE, THE NEEDLE, WITH THE NEEDLE WIRE, WAS INSERTED INTO THE SHEATH DILATOR TO CHECK PROPER FUNCTION. WHEN THE NEEDLE GOT RETRACTED, IT WAS OBSERVED THAT THE NEEDLE HAD SCRATCHED THE INNER TUBE OF THE SHEATH. ADDITIONALLY, THERE WAS VISIBLE INNER DEFORMATION IN THE DISTAL TIP OF THE DILATOR. THE SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE. THE NEEDLE WAS CLEANED TO REMOVE THE PLASTIC. WHEN ATTEMPTING THE TRANSSEPTAL PUNCTURE, THE NEEDLE WAS NOT ABLE TO BE ADVANCED. IT WAS NOTED THAT SOMETHING WAS BLOCKING IT. THE NEEDLE AND THE SHEATH WERE RETRACTED AND VISUAL INSPECTION INDICATED THAT THE TIP OF THE DILATOR WAS DEFORMED AND THE TIP OF THE NEEDLE HAD PLASTIC RESIDUE ON IT. THE OUTCOME OF THIS CASE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18249297 ↗
• MalfunctionNov 28, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A TRANSEPTAL PROCEDURE, THE NEEDLE COULD NOT ADVANCE THROUGH THE SHEATH. THE SHEATH WAS REPLACED, BUT THE ISSUE PERSISTED. SALINE WAS ATTEMPTED TO BE FLUSHED THROUGH THE SHEATH, BUT REMAINED WITHIN THE SHEATH, UNABLE TO ADVANCE THROUGH THE TIP. THE SHEATH AND NEEDLE WERE REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221259 ↗
• MalfunctionDec 18, 2022Break; Break

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS RESISTANCE WHEN ADVANCING THE NEEDLE THROUGH A DILATOR. THE PRODUCTS WERE REMOVED FROM THE PATIENT AND INJECTED WITH SALINE AND PLASTIC PIECES FROM THE DILATOR CAME THROUGH. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16001581 ↗
• MalfunctionNov 23, 2022Break; Break

  IT WAS REPORTED DURING A PROCEDURE WHEN THE SHEATH AND NEEDLE WERE BEING PREPPED, THE NEEDLE SCRATCHED THE PLASTIC MATERIAL INSIDE THE DILATOR OF THE TRANSSEPTAL SHEATH. THE NEEDLE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. THE OUTCOME OF THIS CASE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15855313 ↗
• MalfunctionNov 19, 2022Break; Break

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, COMPATIBILITY ISSUES WERE NOTED BETWEEN THE TRANSSEPTAL NEEDLE AND ANOTHER MANUFACTURERS SHEATH. DURING PREPARATION, WHEN ADVANCING THE NEEDLE THROUGH THE SHEATH, A PIECE OF PLASTIC WAS EXPELLED FROM THE SHEATH WHEN INJECTING SALINE THROUGH THE SYSTEM. THE SHEATH WAS REPLACED TWICE WITHOUT RESOLVING THE ISSUE. SUBSEQUENTLY, THE NEEDLE WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829665 ↗
• MalfunctionSep 19, 2022Break; Break

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE AFTER THE TRANS-SEPTAL PUNCTURE, THE TRANS-SEPTAL NEEDLE WAS REMOVED FROM THE SHEATH AND SHAVINGS WERE OBSERVED. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445247 ↗
• MalfunctionAug 2, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE NEEDLE HAS SCRAPED THE INSIDE OF A DIFFERENT MANUFACTURER'S DILATOR. A BUILD UP OF PLASTIC WAS OBSERVED. THE OUTCOME OF THIS CASE IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147681 ↗
• MalfunctionJun 28, 2022Break; Break

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE NEEDLE WAS USED TO CROSS SEPTUM SUCCESSFULLY. THE GUIDEWIRE WOULD NOT ADVANCE INTO THE SHEATH. THE DILATOR WAS REMOVED AND THE SHEATH WAS FLUSHED. SMALL FRAGMENTS OF PLASTIC WERE SEEN COME OUT OF THE SHEATH. THE NEEDLE SCRAPED THE INSIDE OF THE SHEATH WHEN IT WAS BEING REMOVED. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14844444 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN PERFORMING THE TRANSSEPTAL PUNCTURE, THE TRANSSEPTAL NEEDLE DID NOT PROGRESS EASILY THROUGH THE DILATOR. IT WAS NOTED THE NEEDLE HAD TRANSFIXED THE DILATOR. TWO ADDITIONAL DILATORS WERE USED WITHOUT RESOLVING THE ISSUE. IT WAS NOTED THAT WHEN THE NEEDLE WAS SEEN AT THE DISTAL TIP OF THE DILATOR, PLASTIC REMNANTS WERE SEEN. THE NEEDLE WAS REPLACED ONCE, BUT THE ISSUE PERSISTED. THE NEEDLE WAS REPLACED AGAIN TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938863 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, CARDIAC TAMPONADE OCCURRED DURING THE TRANSSEPTAL ACCESS. THE CASE WAS ABORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade

  MAUDE report 11841425 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT THE NEEDLE WAS REPLACED ONCE, BUT THE ISSUE PERSISTED. THE NEEDLE WAS REPLACED AGAIN TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812479 ↗
• MalfunctionMay 7, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TRANSSEPTAL NEEDLE DID NOT PROGRESS EASILY. THE DILATOR AND NEEDLE WERE REMOVED. IT WAS NOTED THE NEEDLE HAD TRANSFIXED THE DILATOR. TWO ADDITIONAL DILATORS WERE USED AND DIFFICULTY WAS NOTED IN BOTH PROGRESSING THE NEEDLE THROUGH THE DILATORS. WHEN THE NEEDLE WAS PASSED THROUGH THE DISTAL TIP OF THE DILATOR, PLASTIC REMNANTS WERE NOTED. A DIFFERENT TRANSSEPTAL NEEDLE WAS USED AND THE ISSUE RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793815 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THE SMALL AMOUNT OF FLUID IN THE PERICARDIAL SAC WAS PROBABLY RIGHT SIDED.

  Patient problems: Pericardial Effusion

  MAUDE report 11497776 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN PERFORMING THE TRANSSEPTAL PUNCTURE, THE PHYSICIAN DID NOT PUNCTURE THE CORRECT SIDE OF THE HEART. THE AORTA WAS PUNCTURED. CARDIAC SURGERY WAS PERFORMED IN THE ELECTROPHYSIOLOGY (EP) LAB. THE PATIENT WAS THEN MOVED TO THE INTENSIVE CARE UNIT (ICU). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 10743626 ↗
• MalfunctionJul 9, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE TRANSEPTAL NEEDLE WAS ADVANCED THOUGH THE SHEATH, AND PLASTIC WAS SKIVED. THIS OCCURRED AGAIN WITH ANOTHER NEEDLE. THE NEEDLE WAS REPLACED WITH A COMPETITOR PRODUCT TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10252310 ↗
• MalfunctionJul 9, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE TRANSEPTAL NEEDLE WAS ADVANCED THOUGH THE SHEATH, AND PLASTIC WAS SKIVED. THIS OCCURRED AGAIN WITH ANOTHER NEEDLE. THE NEEDLE WAS REPLACED WITH A COMPETITOR PRODUCT TO RESOLVE THE ISSUE. 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 10252299 ↗
• MalfunctionJul 2, 2020Break; Break

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION PROCEDURE, WHEN THE TRANSSEPTAL ACCESS KIT WAS BEING PREPARED, THE TRANSSEPTAL NEEDLE ABRADED THE INTERNAL SURFACE OF THE SHEATH INTRODUCER, AND PLASTIC MATERIAL WAS RELEASED IN FRAGMENTS. THE SHEATH AND NEEDLE WERE REPLACED. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. IT WAS NOTED THE PROCEDURE WAS DELAYED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10226464 ↗
• MalfunctionMar 19, 2020Break; Break

  THE NEEDLE WAS SUSCEPTIBLE TO SKIVING PER THE ORIGINAL EQUIPMENT MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9858005 ↗
• MalfunctionMar 19, 2020Break; Break

  AN ORIGINAL EQUIPMENT MANUFACTURER (OEM) EVALUATED THE SHEATH USED AND DETERMINED THAT A COMBINATION OF THE PRODUCTS IS POTENTIALLY SUSCEPTIBLE TO SKIVING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9858000 ↗
• MalfunctionMar 19, 2020Break; Break

  THE NEEDLE WAS SUSCEPTIBLE TO SKIVING PER THE ORIGINAL EQUIPMENT MANUFACTURER'S INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9857999 ↗
• MalfunctionMar 19, 2020Break; Break

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, THE TRANSSEPTAL NEEDLE WAS SCRATCHING THE INSIDE OF THE DILATOR AND COULD NOT BE ADVANCED OUT OF THE DILATOR. THE NEEDLE AND SHEATH WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE CASE WAS COMPLETED AND NO DEBRIS OR PARTICLES WERE NOTICED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9857984 ↗
• MalfunctionMar 19, 2020Break; Break

  IT WAS REPORTED THAT DURING A TRANSSEPTAL PUNCTURE THE NEEDLE SCRATCHED THE INNER LUMEN OF THE COMPETITOR SHEATH. NO PARTICLES WERE LOOSENED BUT RESISTANCE WAS NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9857957 ↗
• MalfunctionMar 19, 2020Break; Break

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) PROCEDURE, THE NEEDLE WAS UNABLE TO PASS THROUGH THE COMPETITORS SHEATH. THE NEEDLE WAS SCRATCHING INSIDE THE DILATOR. THE NEEDLE 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 9857952 ↗