SJM™ 405112Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734204125), received between Mar 26, 2020 and Feb 6, 2024 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT A LACERATION WAS NOTED ON THE DISTAL END OF THE INTRODUCER, APPROXIMATELY 4CM BEFORE ENTERING THE VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651745 ↗
• MalfunctionJun 2, 2022Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole

  DURING IMPLANTATION OF A SINGLE CHAMBER PACEMAKER, THE SHEATH BROKE DURING ACCESS VIA THE RIGHT SUBCLAVIAN ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575450 ↗
• InjuryNov 11, 2021Entrapment of Device; Difficult to Insert; Entrapment of Device; Difficult to Insert

  DURING A PERCUTANEOUS VENIPUNCTURE, THE GUIDEWIRE BECAME LODGED IN THE NEEDLE AND THE DEVICE WAS REMOVED FROM THE PATIENT. JUGULAR VEIN TRAUMA OCCURRED AND A NEW PUNCTURE WAS REQUIRED AND THE PROCEDURE WAS STOPPED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12794104 ↗
• MalfunctionAug 10, 2021Difficult to Insert; Loose or Intermittent Connection; Difficult to Insert; Loose or Intermittent Connection

  RELATED MANUFACTURING REF: 3005334138-2021-00504, 3005334138-2021-00505. DURING A PACEMAKER IMPLANT PROCEDURE, TWO DILATORS WOULD NOT FIT INTO THE SHEATHS WHICH CAUSED A DELAY IN THE PROCEDURE. A THIRD DEVICE WAS OBTAINED AND TESTED OUTSIDE THE PATIENT AND THE SAME ISSUE OCCURRED. A FOURTH DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300111 ↗
• MalfunctionAug 10, 2021Difficult to Insert; Loose or Intermittent Connection; Difficult to Insert; Loose or Intermittent Connection

  DURING A PACEMAKER IMPLANT PROCEDURE, TWO DILATORS WOULD NOT CLICK OR STAY ON THE SHEATH WHICH CAUSED A DELAY IN THE PROCEDURE. A THIRD DEVICE WAS OBTAINED AND TESTED OUTSIDE THE PATIENT AND THE SAME ISSUE OCCURRED. A FOURTH DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300109 ↗
• MalfunctionAug 10, 2021Difficult to Insert; Loose or Intermittent Connection; Difficult to Insert; Loose or Intermittent Connection

  RELATED MANUFACTURING REF: 3005334138-2021-00505, 3005334138-2021-00506. DURING A PACEMAKER IMPLANT PROCEDURE, TWO DILATORS WOULD NOT FIT INTO THE SHEATHS WHICH CAUSED A DELAY IN THE PROCEDURE. A THIRD DEVICE WAS OBTAINED AND TESTED OUTSIDE THE PATIENT AND THE SAME ISSUE OCCURRED. A FOURTH DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300104 ↗
• InjuryDec 16, 2020Fracture; Difficult to Insert; Fracture; Difficult to Insert

  DURING AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR PROCEDURE, THE SHEATH PEELED AT THE DISTAL END WHILE BEING INSERTED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED. FOLLOWING THE PROCEDURE, A PNEUMOTHORAX WAS DIAGNOSED VIA X-RAY AND A COMPARTMENT HEMATOMA WERE NOTED. THE VASCULAR PUNCTURE WAS NOTED TO BE CLOSED NORMALLY. THE PATIENT WAS SENT TO INTENSIVE CARE FOR CLOSER MONITORING.

  Patient problems: Hematoma; Pneumothorax

  MAUDE report 11019261 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2020-00123. DURING A CRT-D IMPLANT PROCEDURE, THE SUBCLAVIAN VEIN WAS PERFORATED. WHEN ACCESS TO THE SUBCLAVIAN VEIN WAS BEING PERFORMED, SEVERAL PUNCTURES WERE REQUIRED BUT WERE NOT SUCCESSFUL. THE VEIN WAS PERFORATED SEVERAL TIMES AND THE PATIENT'S CONDITION WORSENED WITH BLOOD NOTED TO BE COMING FROM THE MOUTH. THE PATIENT WAS INTUBATED AND REQUIRED VENTILATION SUPPORT, EVENTUALLY BEING TRANSFERRED TO THE SURGICAL OPERATING ROOM IN UNSTABLE CONDITION. OPEN CHEST SURGERY WAS REQUIRED TO STOP THE BLEEDING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Perforation

  MAUDE report 9884933 ↗