Fast-Cath™ 406103Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 05414734013772), received between Sep 24, 2020 and Sep 12, 2025 — classified as 14 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (30 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, AFTER THE INTRODUCER WAS PLACED, BLOOD LEAK FROM THE HEMOSTASIS VALVE DID NOT STOP WHEN WITHDRAWING THE DILATOR. 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 23039552 ↗
• MalfunctionJan 9, 2025Material Separation; Material Separation

  FOLLOWING A TEMPORARY TRANSVENOUS PACING PROCEDURE, A SIDE PORT DETACHMENT OCCURRED. APPROXIMATELY 6 HOURS AFTER SURGERY IT WAS NOTED THAT THE SIDE PORT OF THE SHEATH WAS DETACHED RESULTING IN BLOOD LOSS. THE SHEATH WAS THEN EXCHANGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21119939 ↗
• InjuryDec 4, 2024Material Separation; Material Separation

  DURING THE TRANSVENOUS PACEMAKER INSERTION PROCEDURE, IT WAS NOTED THAT THE SIDEPORT BECAME DISLODGED RESULTING IN BLEEDING. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED. NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED. IT WAS BELIEVED THAT THE SIDEPORT DETACHMENT WAS THE RESULT OF USER ERROR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20843833 ↗
• InjuryDec 4, 2024Material Separation; Material Separation

  DURING THE TRANSVENOUS PACEMAKER INSERTION PROCEDURE, IT WAS NOTED THAT THE SIDEPORT BECAME DISLODGED RESULTING IN BLEEDING. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED. NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20843680 ↗
• MalfunctionDec 2, 2024Material Separation; Material Separation

  DURING A PROCEDURE, WHILE TEMPORARY PACING INSERTION WAS BEING PERFORMED, THE SIDE PORT OF THE SHEATH DETACHED. THE PATIENT WAS DEPENDENT ON PACING, SO THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE SHEATH AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825833 ↗
• MalfunctionDec 2, 2024Material Separation; Material Separation

  DURING A PACEMAKER IMPLANTATION PROCEDURE, WHILE INSERTING THE SHEATH INTO A VEIN, THE SIDE PORT CAME OFF THE SHEATH HUB. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. AIR CONTAMINATION TO THE PATIENT HAS NOT BEEN CONFIRMED. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED DUE TO SHEATH REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825637 ↗
• InjuryOct 25, 2024Material Separation; Material Separation

  TWO DAYS POST PROCEDURE, THE SIDEPORT WAS NOTED TO BE LEAKING WHILE IN THE ICU. WHEN THE NURSE WENT TO REMOVE IT, IT WAS NOTED THE SIDEPORT DETACHED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532072 ↗
• MalfunctionOct 23, 2024Material Separation; Material Separation

  RELATED MANUFACTURING REF: 3005334138-2024-00447, 3005334138-2024-00448. DURING THE PROCEDURE IT WAS NOTED THAT THE SIDEPORT OF THREE INTRODUCERS CAME LOOSE. TWO OF THE THREE INTRODUCERS WERE IN THE PATIENT. A FOURTH WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515548 ↗
• MalfunctionOct 23, 2024Material Separation; Material Separation

  RELATED MANUFACTURING REF: 3005334138-2024-00446, 3005334138-2024-00448. DURING THE PROCEDURE IT WAS NOTED THAT THE SIDE PORT OF THREE INTRODUCERS CAME LOOSE. TWO OF THE THREE INTRODUCERS WERE IN THE PATIENT. A FOURTH WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515364 ↗
• MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A RIGHT HEART CATHETERIZATION PROCEDURE, BLEED BACK FROM THE FAST-CATH INTRODUCER WAS NOTED AFTER REMOVAL OF THE NON-ABBOTT (7F SWAN GANZ) CATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SHEATH WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436646 ↗
• MalfunctionJul 12, 2024Material Separation; Material Separation

  DEVICE RECEIVED. THIS REPORT INCLUDES AN UPDATED ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735828 ↗
• MalfunctionJul 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE INTRODUCER SIDEPORT DETACHED APPROXIMATELY ONE TO TWO DAYS AFTER PLACEMENT IN THREE SEPARATE PATIENT EVENTS. THE INTRODUCER HAD BEEN PLACED IN THE JUGULAR VEIN FOR THE PLACEMENT OF A 5F TEMPORARY PACER WHILE AWAITING A PERMANENT PACER. A PUMP SET WAS CONNECTED AND SET TO KVO. WHILE IN THE ICU, A DAY OR TWO AFTER INTRODUCER PLACEMENT, THE SIDEPORT DISCONNECTED. THE INTRODUCER AND THE TEMPORARY PACER WERE REMOVED AND THE SCHEDULED PACER WAS PLACED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THERE WERE NO REPORTS OF HARD FLUSHING OR PULLING ON THE IV TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735820 ↗
• MalfunctionJul 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE INTRODUCER SIDEPORT DETACHED APPROXIMATELY ONE TO TWO DAYS AFTER PLACEMENT IN THREE SEPARATE PATIENT EVENTS. THE INTRODUCER HAD BEEN PLACED IN THE JUGULAR VEIN FOR THE PLACEMENT OF A 5F TEMPORARY PACER WHILE AWAITING A PERMANENT PACER. A PUMP SET WAS CONNECTED AND SET TO KVO. WHILE IN THE ICU, A DAY OR TWO AFTER INTRODUCER PLACEMENT, THE SIDEPORT DISCONNECTED. THE INTRODUCER AND THE TEMPORARY PACER WERE REMOVED AND THE SCHEDULED PACER WAS PLACED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THERE WERE NO REPORTS OF HARD FLUSHING OR PULLING ON THE IV TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735813 ↗
• InjuryJun 23, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  A PIECE OF THE INTRODUCER BROKE OFF IN THE PATIENT REQUIRING A SNARE FOR REMOVAL. ON MAY 21ST, V-A ECMO WAS INTRODUCED, WITH BLOOD FLOW IN THE RIGHT FEMORAL ARTERY 16.5FR, BLOOD OUTFLOW IN THE LEFT FEMORAL VEIN 21FR. THE SHEATH WAS INSERTED IN THE RIGHT FEMORAL VEIN TO PLACE A TEMPORARY PACING CATHETER FOR BRADYCARDIA. ON MAY 28TH, THE BLOOD INFLOW AND OUTFLOW CANNULA WAS SURGICALLY REMOVED FOLLOWING WITHDRAWAL FROM V-A ECMO. ON MAY 29TH, THE SHEATH WAS REMOVED WHILE COMPRESSING THE INSERTION SITE IN ORDER TO REMOVE THE TEMPORARY PACING CATHETER. THERE WAS SOME RESISTANCE DURING REMOVAL, BUT THE SHEATH WAS REMOVED AS IS WITH DOCTOR'S JUDGEMENT. WHEN THE SHEATH WAS CHECKED AFTER REMOVAL, IT WAS FOUND TO HAVE RUPTURED. THE TIP THAT REMAINED MAY HAVE BEEN OUTSIDE THE BLOOD VESSEL, SO AN INCISION WAS MADE NEAR THE INSERTION SITE, BUT IT COULD NOT BE CONFIRMED. ON MAY 30TH, A CT SCAN CONFIRMED THAT THE REMAINING PART WAS INSIDE THE BLOOD VESSEL. ON THE SAME DAY, AN 11FR SHEATH AND SNARE WERE INSERTED IN THE RIGHT INTERNAL JUGULAR VEIN AND SUCCESSFULLY REMOVED THE PIECE PERCUTANEOUSLY. SINCE THEN, THE PATIENT HAS HAD SEVERE ANEMIA AND HAS UNDERGONE FREQUENT BLOOD TRANSFUSIONS. AFTER SHEA

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19591776 ↗
• InjuryFeb 21, 2024Material Separation; Material Separation

  DURING A BACKUP PROCEDURE FOR THE ORTHOPEDIC SURGERY ON JANUARY 17TH, THE FAST-CATH HEMOSTASIS INTRODUCER WAS INSERTED, AND A NON-ABBOTT (5F SWAN-GANZ TEMPORARY PACING CATHETER) WAS INSERTED. AFTER COMPLETING THE SURGERY, THE FAST-CATH HEMOSTASIS INTRODUCER AND NON-ABBOTT (5F SWAN-GANZ TEMPORARY PACING CATHETER) WERE REMOVED. ON THE EVENING OF JANUARY 30TH DURING THE CATHETER EXAMINATION UNDER RADIOSCOPY, A PORTION OF WHAT APPEARED TO BE THE FAST-CATH HEMOSTASIS INTRODUCER THAT HAD BEEN REMOVED WAS FOUND INSIDE THE BLOOD VESSEL AT THE ENTRANCE OF THE LEFT GROIN VEIN, AND IT WAS REMOVED SMOOTHLY USING FORCEPS. THERE IS A SCRATCH ON THE TIP OF THE FAST-CATH HEMOSTASIS INTRODUCER FROM WHEN IT WAS REMOVED WITH FORCEPS. ON JANUARY 17TH, NO PHYSICAL DAMAGE TO THE SHEATH WAS NOTED AND THERE WERE NO ISSUES OR RESISTANCE NOTED DURING THE PROCEDURE AND THE PATIENT WAS DISCHARGED. THE PATIENT WAS DISCHARGED AGAIN AFTER REMOVAL OF THE RETAINED SHEATH STILL IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18753840 ↗
• InjuryOct 5, 2023Material Separation; Material Separation

  DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, A SHEATH FRACTURE OCCURRED REQUIRING SURGICAL REMOVAL. A PACEL BIPOLAR PACING CATHETER (MODEL #401766, LOT #8906539) WAS PLACED THROUGH THE PATIENT'S NECK, USING THE INTRODUCER. IT WAS THEN FOUND THAT THE SHEATH HAD FRACTURED AT THE TIP NEAR THE END OF THE PROCEDURE. AFTER REMOVING THE COMPONENTS, THE FRACTURED SHEATH HAD TO BE SURGICALLY REMOVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17881359 ↗
• MalfunctionSep 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A BLOOD LEAK OCCURRED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SHEATH WAS INSERTED THROUGH THE RIGHT INTERNAL JUGULAR VEIN, AND IT WAS NOTED THAT BLOOD LEAKED FROM THE HEMOSTASIS VALVE WHEN PLACING THE TEMPORARY CATHETER. THE PLACEMENT WAS STOPPED AND THE CATHETER WAS REMOVED. THE HEMOSTASIS VALVE WAS CHECKED AND PHYSICAL DAMAGE WAS NOTED. 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 17694588 ↗
• MalfunctionAug 3, 2023Material Separation; Material Separation

  DURING DEVICE PREPARATION FOR THE PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE SIDE PORT TUBE DETACHED. 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 17452147 ↗
• MalfunctionJul 25, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING THE PROCEDURE, THE INTRODUCER WAS PERFORATED WHILE PASSING THE BALLOON PROBE THROUGH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389342 ↗
• MalfunctionJul 14, 2023Material Separation; No Apparent Adverse Event; Material Separation; No Apparent Adverse Event

  AFTER FURTHER INFORMATION WAS RECEIVED AND REVIEW IT WAS CONFIRMED THAT THIS EVENT IS A DUPLICATE OF PER-2023-0093693 AND HAS ALREADY BEEN REPORTED UNDER REGULATORY REPORT MDR-2023-26004.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17328044 ↗
• InjuryJul 13, 2023Material Separation; Material Separation

  DURING A PROCEDURE, THE SHEATH TUBING SEPARATED FROM THE HUB UPON ATTEMPTING TO (DC) DISCONTINUE THE GROIN SHEATH POST PROCEDURE. LEAVING ONLY THE PLASTIC SHEATH TUBING IN THE BODY. THE DISCONNECTED SHEATH TUBING WAS ABLE TO BE RETRIEVED OUT OF THE PATIENT'S GROIN BEFORE IT HAD A CHANCE TO MIGRATE ELSEWHERE BOTH TIMES.

  Patient problems: Foreign Body In Patient

  MAUDE report 17316796 ↗
• InjuryJun 13, 2023Material Separation; Material Separation

  DURING THE PROCEDURE, THE SHEATH TUBING SEPARATED FROM THE HUB WHEN ATTEMPTING TO REMOVE THE SHEATH POST PROCEDURE, LEAVING A PORTION OF THE SHEATH TUBING IN THE PATIENT. A CUT DOWN PROCEDURE WAS PERFORMED TO RETRIEVE THE DETACHED PORTION OF THE SHEATH WAS ABLE TO BE RETRIEVED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17118276 ↗
• InjuryJun 13, 2023Material Separation; Material Separation

  AT THE END OF THE PROCEDURE, IT WAS NOTED THAT THE SHEATH TUBING SEPARATED FROM THE HUB WHEN ATTEMPTING TO REMOVE THE SHEATH, LEAVING A PORTION OF THE SHEATH TUBING IN THE PATIENT. A CUT DOWN PROCEDURE WAS PERFORMED TO RETRIEVE THE DETACHED PORTION OF THE SHEATH WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17118234 ↗
• MalfunctionJun 5, 2023Material Separation; Material Separation

  AT THE END OF A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE DEVICE DETACHED AND A PORTION REMAINED IN THE PATIENT REQUIRING ADDITIONAL INTERVENTION. ANESTHESIA INSERTED A CENTRAL VENOUS LINE AT THE RIGHT INTERNAL JUGULAR AND INTERVENTIONAL CARDIOLOGIST PLACED A TEMPORARY PACEMAKER THROUGH THE LINE, AND THE PROCEDURE WAS COMPLETED. AT THE END OF THE PROCEDURE, INFILTRATION WAS NOTED AT THE ACCESS SITE AND IT WAS DECIDED TO REMOVE THE SHEATH. UPON REMOVAL OF THE SHEATH, IT SEPARATED LEAVING APPROXIMATELY 9CM OF THE SHEATH IN THE PATIENT. USING FLUOROSCOPY, AN INTERVENTIONAL CARDIOLOGIST WENT THROUGH THE GROIN AND RETRIEVED THE DETACHED PORTION OF THE DEVICE. A VENOUS ULTRASOUND WAS PERFORMED WHICH CONFIRMED THERE WAS NO ADDITIONAL HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17058769 ↗
• InjuryMay 22, 2023Material Separation; Material Separation

  DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVI) PROCEDURE, A PIECE OF THE INTRODUCER DETACHED UPON REMOVAL AND REMAINED IN THE PATIENT. DURING THE EXTERNAL PACEMAKER PLACEMENT, THE INTRODUCER WAS USED TO PLACE THE PACEL. THE FOLLOWING DAY, WHEN ATTEMPTING TO REMOVE THE DEVICES, A PORTION OF THE INTRODUCER SHEATH REMAINED IN THE ARTERY. THE PATIENT WAS TRANSFERRED TO SURGERY TO RETRIEVE THE DETACHED PORTION VIA FEMORAL ACCESS USING THE LASSO SYSTEM. ONCE THE INTRODUCER WAS REMOVED, THE EXTERNAL PACEMAKER WAS NO LONGER NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16976589 ↗