SJM™ 405104Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05414734204088), received between Nov 14, 2018 and Dec 2, 2020 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2020Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  DURING A DEVICE REPLACEMENT AND RV LEAD PLACEMENT PROCEDURE, THE CASE WAS CANCELLED. THE TIP OF THE SHEATH WAS BENT WHEN INSERTING INTO THE RIGHT SUBCLAVIAN VEIN, AND IT COULD NOT BE INSERTED. THE INTRODUCER WAS REPLACED AND PEELED, BUT THE LEAD COULD NOT ADVANCE TO THE TARGET POSITION. THE REPLACEMENT INTRODUCER ALSO BECAME BENT DURING USE. THE PROCEDURE WAS RESCHEDULED, AND THE SHEATH WOULD BE INSERTED VIA THE LEFT SUBCLAVIAN VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10935980 ↗
• MalfunctionNov 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A BLOOD LEAK OCCURRED. AFTER PLACING THE INTRODUCER AND DILATOR, BLOOD BEGAN TO LEAK FROM THE INTRODUCER HUB. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL PUNCTURE WAS REQUIRED FOR REPLACING THE INTRODUCER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10882152 ↗
• InjuryNov 17, 2020Difficult to Insert; Difficult to Insert

  DURING THE PROCEDURE, A SECOND PUNCTURE WAS CONDUCTED BECAUSE THE GUIDEWIRE BECAME STUCK IN THE PUNCTURE NEEDLE. WHEN ATTEMPTING TO INSERT THE GUIDEWIRE INTO THE NEEDLE, THE GUIDEWIRE BECAME STUCK IN THE NEEDLE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10857604 ↗
• InjuryOct 15, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  DURING THE PACEMAKER IMPLANT PROCEDURE, DIFFICULTY PEELING THE INTRODUCER CAUSED A PROCEDURE DELAY. SCISSORS WERE USED TO FINISH PEELING THE INTRODUCER, WHICH ADDED BETWEEN TEN AND FIFTEEN MINUTES TO THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10684052 ↗
• MalfunctionSep 28, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE INTRODUCER WAS DIFFICULT TO PEEL AND A PLIERS / SCISSORS HAS TO BE USED TO PEEL THE SHEATH WHICH DELAYED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10594128 ↗
• InjuryAug 26, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  DURING A PROCEDURE, WHEN REMOVING THE INTRODUCER FROM THE PATIENT THERE WAS AN ISSUE WITH PEELING THE SHEATH, CAUSING IT TO TEAR. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT BUT IT DID CAUSE A DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457770 ↗
• MalfunctionAug 19, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE INTRODUCER DID NOT PEEL PROPERLY AND TORE DURING THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT, HOWEVER A DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10425066 ↗
• MalfunctionAug 19, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE INTRODUCER DID NOT PEEL PROPERLY AND TORE DURING THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT, HOWEVER A DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10424984 ↗
• MalfunctionAug 18, 2020Fracture; Fracture

  DURING THE PROCEDURE, THE SHEATH DID NOT PEEL PROPERLY AND A SCALPEL HAD TO BE USED TO PEEL THE DEVICE. WHEN PEELING, THE SHEATH SPLIT INTO SEVERAL PIECES AND HAD TO BE REMOVED FROM THE PATIENT. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 10421451 ↗
• MalfunctionJun 23, 2020Difficult to Remove; Difficult to Remove

  UPON RECEIPT OF THE DEVICE, TISSUE WAS NOTED TO BE ATTACHED. HOWEVER, THERE WERE NO PATIENT CONSEQUENCES AND NO ADDITIONAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183611 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2018-00422. DURING A PACEMAKER IMPLANTATION PROCEDURE BLEEDING OCCURRED AT THE VASCULAR ACCESS SITE THAT COULD NOT BE CONTROLLED. EVENTUALLY HEMOSTASIS WAS ACHIEVED WITH SURGICAL INTERVENTION AND THE PROCEDURE WAS CANCELLED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Blood Loss

  MAUDE report 8071341 ↗