Fast-CathRecalls & reported problems across all models
St. Jude Medical, Inc. · 71 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,364
- Deaths reported
- 7
- Injuries reported
- 123
- Recalls
- 2
We found 71 models of Fast-Cath by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,364 adverse event reports in the FDA's MAUDE database, received between Sep 20, 2016 and Sep 24, 2026 — classified as 7 deaths, 123 injuries, 1,234 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (404 reports).
2 FDA recall records name at least one of these models by its device identifier.
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
Reports received per month, all models
Fast-Cath recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 9, 2019Terminated
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Z-0789-2020 · Root cause: Packaging · Recall details · FDA record ↗
- Dec 9, 2019Terminated
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Z-0783-2020 · Root cause: Packaging · Recall details · FDA record ↗
Most reported Fast-Cath problems
Device problems
- Fluid/Blood Leak404
- Component Misassembled287
- Gas/Air Leak152
- Material Separation148
- Flaked143
- Material Puncture/Hole100
- Difficult to Insert57
- Adverse Event Without Identified Device or Use Problem27
Patient problems
- No Clinical Signs, Symptoms or Conditions666
- No Consequences Or Impact To Patient444
- No Patient Involvement151
- Foreign Body In Patient39
- Hemorrhage/Blood Loss/Bleeding24
- Cardiac Perforation14
- Stroke/CVA11
- Device Embedded In Tissue or Plaque10
Fast-Cath models
71 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Fast-Cath™ 406849INTRODUCER, CATHETER420 reports
- Fast-Cath™ 406303INTRODUCER, CATHETER1 recall226 reports
- Fast-Cath™ 406143INTRODUCER, CATHETER1 recall69 reports
- Fast-Cath™ 406840INTRODUCER, CATHETER2 deaths102 reports
- Fast-Cath™ 406968INTRODUCER, CATHETER84 reports
- Fast-Cath™ 406136INTRODUCER, CATHETER1 death44 reports
- Fast-Cath™ 406948INTRODUCER, CATHETER42 reports
- Fast-Cath™ 406853INTRODUCER, CATHETER39 reports
- Fast-Cath™ 406103INTRODUCER, CATHETER36 reports
- Fast-Cath™ 406844INTRODUCER, CATHETER28 reports
- Fast-Cath™ 406180INTRODUCER, CATHETER23 reports
- Fast-Cath™ 406137INTRODUCER, CATHETER22 reports
- Fast-Cath™ 406114INTRODUCER, CATHETER18 reports
- Fast-Cath™ 406963INTRODUCER, CATHETER17 reports
- Fast-Cath™ 406107INTRODUCER, CATHETER16 reports
- Fast-Cath™ 406306INTRODUCER, CATHETER15 reports
- Fast-Cath™ 406704INTRODUCER, CATHETER14 reports
- Fast-Cath™ 406116INTRODUCER, CATHETER11 reports
- Fast-Cath™ 406702INTRODUCER, CATHETER10 reports
- Fast-Cath™ 406701INTRODUCER, CATHETER9 reports
- Fast-Cath™ 406804INTRODUCER, CATHETER7 reports
- Fast-Cath™ 406962INTRODUCER, CATHETER7 reports
- Fast-Cath™ 406112INTRODUCER, CATHETER6 reports
- Fast-Cath™ 406362INTRODUCER, CATHETER2 deaths6 reports
- Fast-Cath™ 406333INTRODUCER, CATHETER6 reports
- Fast-Cath™ 406128INTRODUCER, CATHETER5 reports
- Fast-Cath™ 406955INTRODUCER, CATHETER5 reports
- Fast-Cath™ 406104INTRODUCER, CATHETER4 reports
- Fast-Cath™ 406123INTRODUCER, CATHETER4 reports
- Fast-Cath™ 406124INTRODUCER, CATHETER1 death4 reports
- Fast-Cath™ 406183INTRODUCER, CATHETER4 reports
- Fast-Cath™ 406307INTRODUCER, CATHETER4 reports
- Fast-Cath™ 406961INTRODUCER, CATHETER4 reports
- Fast-Cath™ 406705INTRODUCER, CATHETER4 reports
- Fast-Cath™ 406120INTRODUCER, CATHETER3 reports
- Fast-Cath™ 406354INTRODUCER, CATHETER3 reports
- Fast-Cath™ 406842INTRODUCER, CATHETER3 reports
- Fast-Cath™ 406153INTRODUCER, CATHETER2 reports
- Fast-Cath™ 406868INTRODUCER, CATHETER2 reports
- Fast-Cath™ 406898INTRODUCER, CATHETER2 reports
- Fast-Cath™ 406969INTRODUCER, CATHETER2 reports
- Fast-Cath™ 407400INTRODUCER, CATHETER2 reports
- Fast-Cath™ 407436INTRODUCER, CATHETER2 reports
- Fast-Cath™ 406133INTRODUCER, CATHETER1 report
- Fast-Cath™ 406787INTRODUCER, CATHETER1 report
- Fast-Cath™ 406773INTRODUCER, CATHETER1 report
- Fast-Cath™ 406182INTRODUCER, CATHETER1 report
- Fast-Cath™ 406783INTRODUCER, CATHETER1 report
- Fast-Cath™ 406772INTRODUCER, CATHETER1 report
- Fast-Cath™ 406108INTRODUCER, CATHETER1 report
- Fast-Cath™ 406118INTRODUCER, CATHETER1 report
- Fast-Cath™ 406142INTRODUCER, CATHETER1 report
- Fast-Cath™ 406188INTRODUCER, CATHETER1 report
- Fast-Cath™ 406244INTRODUCER, CATHETER1 report
- Fast-Cath™ 406102INTRODUCER, CATHETER1 report
- Fast-Cath™ 406845INTRODUCER, CATHETER1 report
- Fast-Cath™ 406857INTRODUCER, CATHETER1 report
- Fast-Cath™ 406885INTRODUCER, CATHETER1 report
- Fast-Cath™ 406965INTRODUCER, CATHETER1 report
- Fast-Cath™ 406553INTRODUCER, CATHETER1 report
- Fast-Cath™ 406802INTRODUCER, CATHETER1 report
- Fast-Cath™ 406851INTRODUCER, CATHETER1 report
- Fast-Cath™ 406902INTRODUCER, CATHETER1 death1 report
- Fast-Cath™ 406949INTRODUCER, CATHETER1 report
- Fast-Cath™ 406964Introducer, catheter1 report
- Fast-Cath™ 406331INTRODUCER, CATHETER1 report
- Fast-Cath™ 406543INTRODUCER, CATHETER1 report
- Fast-Cath™ 406700INTRODUCER, CATHETER1 report
- Fast-Cath™ 406706INTRODUCER, CATHETER1 report
- Fast-Cath™ 406707INTRODUCER, CATHETER1 report
- Fast-Cath™ 406350INTRODUCER, CATHETER1 report
Recent Fast-Cath adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Material Puncture/Hole
During the PFO procedure, a femoral vein dissection was noted during transseptal puncture after a puncture of the Fast-Cath sheath. Under fluoro it was noted that the needle was observed passing through the wall of the Fast-Cath introducer. The BRK needle and the Fast-Cath sheath were removed from the patient. It was noted that the patient experienced a femoral vein dissection without any other complication. There were no interventions performed and the patient remained stable.
Patient problems: Vascular Dissection
MAUDE report 50883396 ↗MalfunctionSep 22, 2026Gas/Air Leak
During an atrial fibrillation procedure, air was aspirated from the Fast-Cath SL0 introducer when inserting the dilator and pulling the syringe. The introducer was replaced, and the procedure was completed with no adverse patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857252 ↗MalfunctionAug 24, 2026Gas/Air Leak
During an atrial fibrillation procedure, an air leak was noted from the hemostasis valve on the Fast-Cath sheath after insertions and transseptal puncture. The Fast-Cath sheath was exchanged, and the procedure was completed with no adverse patient health consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50409042 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
During an atrial fibrillation procedure, ST elevation was noted during a guidewire exchange in the Fast-Cath sheath. Following difficult femoral venous access and transseptal puncture, the physician opted to switch to a stiffer guidewire to help advancement of the Agilis sheath through the kinked femoral vein. The Fast-Cath sheath was in the left atrium, and the guidewire was located in the left superior pulmonary vein. While withdrawing the guidewire, the patient developed ST elevation on the ECG. It was noted that the guidewire was not withdrawn with the dilator, which is alleged to have caused air bubbles that presumably got into the coronaries. The patient became hemodynamically unstable, pulse was lost, asystole on ECG and decrease in blood pressure. Akrinor was administered for hemodynamic support. CPR was performed for a few seconds. Heartbeat was obtained with only a rate of approximately 30 beats per minute. Emergent ventricular pacing was started and performed by an Inquiry catheter which was placed in the RV. The ST elevation was noted to gradually resolve over the next few minutes. The patient's hemodynamic condition slowly stabilized and ventricular pacing was able to
Patient problems: Air Embolism; Arrhythmia; Low Blood Pressure/ Hypotension
MAUDE report 50181583 ↗MalfunctionFeb 24, 2026Fluid/Blood Leak
DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, BLOOD LEAKED FROM THE HEMOSTATIC VALVE. WHEN THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM AND THE DILATOR WAS REMOVED, BLOOD LEAKAGE WAS OBSERVED FROM THE HEMOSTATIC VALVE. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430450 ↗MalfunctionFeb 3, 2026Fluid/Blood Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM, AND A NON-ABBOTT RING CATHETER WAS INSERTED. BLOOD LEAKAGE FROM THE HEMOSTATIC VALVE WAS OBSERVED AFTER FLUSHING. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246286 ↗MalfunctionJan 27, 2026Gas/Air Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE WITH PULSED FIELD ABLATION, WHEN THE CATHETER WAS INSERTED, AIR ENTERED THE SYRINGE DURING FLUSHING. VISUAL INSPECTION REVEALED THAT THE HEMOSTATIC VALVE APPEARED LOOSE AND WIDENED. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193599 ↗MalfunctionJan 22, 2026Fluid/Blood Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH VALVE WAS LEAKING BLOOD. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24147241 ↗MalfunctionDec 30, 2025Flaked; Flaked
DURING THE ATRIAL FIBRILLATION, EVIDENCE OF SKIVING WAS OBSERVED. AFTER THE NEEDLE FOR THE TRANSSEPTAL PUNCTURE HAD BEEN INSERTED THROUGH THE DILATOR OF THE SHEATH AND WITHDRAWN, THE GUIDEWIRE COULD NO LONGER BE ADVANCED THROUGH THE DILATOR. AFTER REMOVING THE SHEATH AND DILATOR FROM THE PATIENT, THE PHYSICIAN ATTEMPTED TO FORCE THE WIRE THROUGH THE DILATOR AGAIN, AND SMALL PLASTIC PARTICLES EMERGED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927136 ↗MalfunctionDec 30, 2025Flaked; Flaked
THIS REPORT IS TO ADVISE OF SKIVING THAT WAS NOTED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23921930 ↗MalfunctionDec 29, 2025Material Separation; Material Separation
DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE NON-ABBOTT CATHETER (JLL ELECTRODE CATHETER) WAS INSERTED, RESISTANCE WAS MET AND IT COULD NOT BE INSERTED. UPON INSPECTING THE SHEATH, IT WAS NOTED THAT THE CONNECTOR PARTS HAD BROKEN OFF. THERE WAS NO DAMAGE NOTED ON THE NON-ABBOTT CATHETER (JLL ELECTRODE CATHETER). THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23918752 ↗MalfunctionDec 23, 2025Flaked; Flaked
THIS REPORT IS TO ADVISE OF SKIVING FOUND IN THE SHEATH DURING ANALYSIS. DURING THE LAAO (LEFT ATRIAL APPENDAGE OCCLUSION) PROCEDURE, WHEN USING THE BRK NEEDLE AND FAST-CATH INTRODUCER FOR THE TRANSSEPTAL PUNCTURE, IT WAS NOTED THAT THE BRK NEEDLE COULD NOT PASS THROUGH INTRODUCER AFTER MULTIPLE ATTEMPTS. THE STYLET WAS USED, AND THE NEEDLE WAS NOT RESHAPED. THE INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL PUNCTURE SITE WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23885947 ↗MalfunctionDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING AN AF PROCEDURE, AFTER INSERTING THE SHEATH INTO THE LEFT ATRIUM AND REMOVING THE DILATOR, BLOOD LEAKED FROM THE HEMOSTATIC VALVE PRIOR TO CATHETER INSERTION. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865654 ↗MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING A PROCEDURE, AFTER INSERTING THE GUIDEWIRE, THE SHEATH WAS NOTED TO BE LEAKING AROUND THE GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23825161 ↗MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKAGE WAS OBSERVED FROM THE HEMOSTASIS VALVE AFTER THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM. THIS OCCURRED AFTER THE DILATOR WAS REMOVED PRIOR TO CATHETER INSERTION. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824610 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page