Reflexion Spiral™ Bi-Directional Variable Radius CatheterRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734206211), received between Jul 18, 2018 and May 27, 2021 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2021Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION / PULMONARY VEIN CONTRACTION PROCEDURE, BLOOD WAS NOTED AT THE CATHETER HANDLE. UPON REMOVAL FROM THE PATIENT, A CRACK WAS NOTED AT THE DISTAL END OF THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893256 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2020-00345, 3005334138-2020-00304, 3008452825-2020-00353. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING ABLATION OF THE PULMONARY VEIN, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION. THE LOCATION AND CAUSE OF THE EFFUSION REMAINS UNKNOWN. PROTAMINE WAS ADMINISTERED AND NO FURTHER INTERVENTION WAS REQUIRED. THERE WERE NO FURTHER COMPLICATIONS AND THE PATIENT WAS STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 10279816 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURE REF: 3008452825-2019-00175. DURING AN ABLATION PROCEDURE IN THE LEFT ATRIUM, A PERICARDIAL EFFUSION OCCURRED. DURING ABLATION, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 8522345 ↗
• DeathJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2019-00022, 3005334138-2019-00028, 3005334138-2019-00029, 3008452825-2019-00023, 3005334138-2019-00030, 2182269-2019-00007. FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPIRED. DURING THE PROCEDURE, THE SEPTUM FELT HARD (NON-ELASTIC), FIBROTIC AND RESISTANT DUE TO A PREVIOUS PROCEDURE. DURING POST PROCEDURE HOSPITALIZATION, A PERICARDIAL EFFUSION WAS DISCOVERED WHICH EVOLVED INTO CARDIAC ARREST DURING THE NIGHT. REANIMATION WITH CARDIAC MASSAGE WAS PERFORMED, HOWEVER THE EFFECT OF THE CARDIAC ARREST LED TO CEREBRAL DEATH EIGHT DAYS POST PROCEDURE AND THE PATIENT EXPIRED ON (B)(6) 2019. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Death

  MAUDE report 8276869 ↗
• InjuryJul 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 9680001-2018-00105, 2182269-2018-00091, 3005334138-2018-00209, 3008452825-2018-00237. DURING A WIDE AREA CIRCUMFERENTIAL ATRIAL FIBRILLATION ABLATION PROCEDURE A CARDIAC PERFORATION OCCURRED. FOLLOWING DUAL TRANSSEPTAL ACCESS AND PULMONARY VEIN ABLATION A PERFORATION WAS DIAGNOSED VIA AN ULTRASOUND CATHETER. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE ABLATION PROCEDURE WAS CONTINUED WITH NO FURTHER ADVERSE PATIENT CONSEQUENCES. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 7698131 ↗