Reflexion Spiral™ D402893Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05414734216654), received between Sep 21, 2016 and Dec 16, 2022 — classified as 1 death, 11 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE BEGINNING OF AN ATRIAL FIBRILLATION PROCEDURE, WHEN MAPPING WAS STARTED WITH THE TACTICATH SE AND REFLEXION SPIRAL CATHETER, AN ACUTE PERICARDIAL EFFUSION WAS NOTED ON THE ICE IMAGE. THE ATRIAL FIBRILLATION CASE WAS BEGUN, TRANSSEPTAL WAS PERFORMED AND LEFT ATRIAL MAPPING GEOMETRY COMMENCED. THE PHYSICIAN THOUGHT THE GEOMETRY LOOKED ODD AND ASKED TO SEE THE PRIOR STUDY FROM (B)(6) 2017. AFTER REVIEWING THAT STUDY HE RETURNED TABLESIDE TO CONTINUE AND NOTED AN EFFUSION ON THE ICE IMAGE. THE PROCEDURE WAS STOPPED AND A PERICARDIOCENTESIS WAS PERFORMED. THERE WERE MULTIPLE PERFORATIONS ON THE LEFT SIDE OF THE HEART. THE CARDIOVASCULAR SURGEON IN HOUSE WAS NOTIFIED AND THE PATIENT WAS EVENTUALLY TAKEN TO HAVE A PRESUMED PERFORATION REPAIRED. THE PATIENT WAS EXTUBATED (B)(6) AND IS STABLE. THERE WAS NO ALLEGED ISSUE WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 15996391 ↗
• MalfunctionMar 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PAROXYSMAL FIBRILLATION ABLATION PROCEDURE, A BLOOD LEAK WAS NOTED AT THE CATHETER HANDLE APPROXIMATELY HALF WAY THROUGH THE PROCEDURE. THEN, DURING THE VEIN ISOLATION, BLOOD WAS NOTED TO BE DRIPPING FROM THE SAME LOCATION. THE PROCEDURE WAS CONTINUED WITH THE SAME CATHETER AND EVENTUALLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440029 ↗
• MalfunctionAug 26, 2020Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS, CONFIRMING A SHAFT FRACTURE ON THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10454297 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2020-00429, 3008452825-2020-00430, 3008452825-2020-00431, 3008452825-2020-00432, 3005334138-2020-00374. DURING AN PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. NEAR THE END OF THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. A TRANSTHORACIC ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE. THE PATIENT HAS REMAINED IN STABLE CONDITION.

  Patient problems: Cardiac Perforation

  MAUDE report 10431393 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2020-00308, 3008452825-2020-00309, 3008452825-2020-00310. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER THE TRANSSEPTAL PUNCTURE HAD BEEN PERFORMED, AND GEOMETRY WAS BEING COLLECTED, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 10275389 ↗
• MalfunctionJun 25, 2020Material Frayed; Material Frayed

  TOWARD THE END OF AN ATRIAL FIBRILLATION PROCEDURE, SLIGHT RESISTANCE WAS NOTED WHEN THE CATHETER WAS REMOVED FROM THE PATIENT. WHEN THE DEVICE WAS REMOVED, THE OUTER MATERIAL ON THE CATHETER LOOP WAS FRAYED, EXPOSING THE INTERNAL COMPONENTS. ADDITIONALLY, THE ELECTRODES WERE DISPLACED FROM THEIR ORIGINAL POSITIONS. NO ANOMALIES WERE NOTED WHILE MAPPING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICES ARE STORED IN THEIR ORIGINAL PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10195442 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2020-00100, 3005334138-2020-00065, 3008452825-2020-00101, 3008452825-2020-00102. FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. SEVEN HOURS POST PROCEDURE THE PATIENT EXPERIENCED BACK PAIN. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9746238 ↗
• MalfunctionNov 7, 2019Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS REVEALED A DETACHED ELECTRODE AND EXPOSED WIRES ON THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9289662 ↗
• InjuryOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2019-00568, 3008452825-2019-00510, 3008452825-2019-00511, 2182269-2019-00180, 3008452825-2019-00512. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AS GEOMETRY WAS BEING COLLECTED THE PATIENT BECAME HYPOTENSIVE. A ECHOCARDIOGRAM WAS PERFORMED, REVEALING THE EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9245222 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2019-00533, 3008452825-2019-00534, 3008452825-2019-00535, 3005334138-2019-00588, 3008452825-2019-00536. DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AN ISOLATION OF THE PULMONARY VEINS AND AN ABLATION OF THE MITRAL ISTHMUS WAS PERFORMED WITH SEVERAL RADIOFREQUENCY DELIVERIES ON THE CORONARY SINUS. FOLLOWING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND EXPERIENCED CHEST PAIN IN THE RECOVERY ROOM. A PERICARDIAL EFFUSION WAS CONFIRMED WITH ULTRASOUND AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE CAUSE AND LOCATION OF THE PERICARDIAL EFFUSION IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9240517 ↗
• MalfunctionJul 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, AFTER A FEW HOURS BLOOD WAS NOTED TO BE LEAKING FROM THE HANDLE OF THE CATHETER. THE PROCEDURE WAS STILL ABLE TO BE COMPLETED WITH THE REPORTED DEVICE, WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8827758 ↗
• MalfunctionJul 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PROCEDURE, WHEN THE CATHETER WAS IN THE LEFT ATRIUM, BLOOD WAS NOTED TO LEAK FROM THE HANDLE OF THE CATHETER. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8804578 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2019-00075, 2030404-2019-00009, 3005334138-2019-00090. FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PATIENT EXPERIENCED A STROKE. IN THE RECOVERY ROOM, A CROOKED MOUTH AND FAILURE TO RESPOND WAS NOTED IN THE PATIENT. A STROKE WAS SUSPECTED AND THE PATIENT WAS TRANSFERRED TO ANOTHER CENTER AND WAS FOLLOWED. THE CAUSE OF THE STROKE IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 8350445 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2019-00003, 3008452825-2019-00001, 3005334138-2019-00004, 3008452825-2019-00002. DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE SPIRAL CATHETER WAS USED TO CREATE THE GEOMETRY BUT THE GEOMETRY DID NOT APPEAR CORRECT. AN ECHOGRAM REVEALED A PERICARDIAL EFFUSION ON THE POSTERIOR WALL. NO ABLATION HAD BEEN CARRIED OUT PRIOR TO THE EFFUSION. A PERICARDIAL DRAIN WAS USED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8219322 ↗
• DeathDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 9680001-2018-00186, 3008452825-2018-00435, 3005334138-2018-00512, 3008452825-2018-00436, 3008452825-2018-00439. TWO DAYS FOLLOWING A PULMONARY VEIN ISOLATION PROCEDURE THE PATIENT EXPIRED. NO DEVICE PERFORMANCE ISSUES WERE NOTED THROUGHOUT THE PROCEDURE. POST ABLATION THE PATIENT WENT INTO ATRIAL FIBRILLATION AND WAS CARDIOVERTED. A TRANSESOPHAGEAL ECHO WAS PERFORMED REVEALING NO TAMPONADE OR CLOTS IN THE LEFT ATRIAL APPENDAGE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018 AND EXPIRED (B)(6) 2018. A CORONER'S CT SCAN CONFIRMED THERE WAS NO TAMPONADE, CLOTS, OR ESOPHAGEAL INJURY.

  Patient problems: Death

  MAUDE report 8181013 ↗
• InjuryOct 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 3005334138-2018-00385, 3005334138-2018-00386, 3008452825-2018-00359, 3008452825-2018-00360. FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. APPROXIMATELY TWO HOURS FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED PAIN AND BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS DISCHARGED TWO DAYS LATER. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8011173 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2018-00323, 3005334138-2018-00333. DURING A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING A SUCCESSFUL TRANSSEPTAL PUNCTURE, THE ABLATION CATHETER WAS INSERTED INTO THE LEFT ATRIUM WITHOUT DIFFICULTY AND GEOMETRY COLLECTION BEGAN WITH THE SPIRAL CATHETER. FOLLOWING 10 MINUTES OF MAPPING, THE PATIENT BECAME HYPOTENSIVE AND FLUOROSCOPY CONFIRMED THE HEART WAS COMPRESSED. A TRANSTHORACIC ECHOCARDIOGRAM WAS USED TO CONFIRM A PERICARDIAL EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 7901431 ↗
• InjuryAug 16, 2018Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURER REFERENCE NUMBER: 2182269-2018-00105. DURING THE PROCEDURE, NOISE WAS NOTED ON THE DISTAL PAIR OF ELECTRODES. TROUBLESHOOTING INCLUDING CHANGING THE PINBOX AND REPLACING THE CONNECTING CABLE BUT THE NOISE REMAINED. THE CATHETER WAS REPLACED AND THE SAME ISSUE OCCURRED, BUT THE NOISE EVENTUALLY RESOLVED SPONTANEOUSLY. THERE WAS A CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE TO TROUBLESHOOT, BUT THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7790706 ↗
• MalfunctionSep 21, 2016Communication or Transmission Problem

  UPON MAPPING OF PROCESS OF ABLATION, CS LEAD 7-8 WOULD NOT COMMUNICATE PROPERLY AS SIGNAL DESIGNATION WAS BLANK. CONNECTING CABLES WERE EXCHANGED WITH SAME RESULTS. CATHETER EXCHANGED SUCCESSFULLY, CASE COMMENCED WITHOUT INJURY TO PT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5973243 ↗