SJM™ 405154Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734204415), received between Nov 14, 2018 and Nov 25, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2020Difficult to Insert; Material Puncture/Hole; Difficult to Insert; Material Puncture/Hole

  DURING THE PROCEDURE, THE RV ELECTRODE WAS ATTEMPTED TO BE INSERTED THROUGH THE INTRODUCER. WHEN THE RV ELECTRODE WAS INSERTED, RESISTANCE WAS FELT AFTER BEING INSERTED A COUPLE OF CENTIMETERS. THE ELECTRODE WAS REMOVED FROM THE INTRODUCER AND THEN THE INTRODUCER WAS REMOVED FROM THE PATIENT. A SMALL HOLE WAS NOTED IN THE MIDDLE OF THE INTRODUCER. WHEN ORIGINALLY UNPACKING THE SHEATH, NO HOLE WAS NOTED. MOREOVER, WHEN INSERTING THE SHEATH INTO THE VEIN WITH THE DILATOR, NO ISSUES WERE NOTED. THE CEPHALIC VEIN COULD NO LONGER BE USED DUE TO THE SLUICE, AND THEN IT STARTED BLEEDING. THE BLEEDING WAS ABLE TO BE CONTROLLED BY APPLYING PRESSURE. THE SUBCLAVIAN VEIN WAS THEN USED, AND THE RV ELECTRODE WAS SUCCESSFULLY IMPLANTED WITH A NEW INTRODUCER. AFTER SEWING THE ELECTRODE INTO THE TISSUE, THE PATIENT BLED OVER THE PUNCTURE SITE OF THE SUBCLAVIAN. BLEEDING THROUGH THE SHEATH ON THE CEPHALIC MEMBRANE COULD NOT BE RULED OUT BY THE PHYSICIAN. THE BLEEDING WAS ALSO STOPPED VIA MANUAL PRESSURE. THE PATIENT WAS NOTED TO BE STABLE DURING THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10901143 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS: 3005334138-2020-00457. FOLLOWING AN LV IMPLANT PROCEDURE, DURING FOLLOW-UP IN THE CLINIC, A PNEUMOTHORAX WAS SEEN ON THE LEFT LUNG OF THE PATIENT. THE PATIENT WAS HOSPITALIZED AND REMAINED IN GOOD CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Pneumothorax

  MAUDE report 10669557 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS: 3005334138-2020-00458. FOLLOWING AN LV IMPLANT PROCEDURE, DURING FOLLOW-UP IN THE CLINIC, A PNEUMOTHORAX WAS SEEN ON THE LEFT LUNG OF THE PATIENT. THE PATIENT WAS HOSPITALIZED AND REMAINED IN GOOD CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Pneumothorax

  MAUDE report 10669553 ↗
• InjuryJul 10, 2019Use of Device Problem; Use of Device Problem

  IN (B)(6) 2018 THE USER FACILITY PLACED A SINGLE UNOPENED DEVICE WITH A USE-BY DATE OF 31 MAY 2019 BACK INTO THE INCORRECT OUTER BOX, WHICH REFLECTED A USE-BY DATE OF SEPTEMBER 2019. THIS SHEATH WAS RETURNED TO THE MANUFACTURER AND LATER WAS SENT OUT TO ANOTHER USER. THE DEVICE WAS USED IN THE PROCEDURE ON (B)(6) 2019 AND LATER DETERMINED TO HAVE BEEN USED AFTER THE EXPIRATION DATE. NO ADVERSE CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777720 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANTATION PROCEDURE, A PNEUMOTHORAX OCCURRED. WHEN PUNCTURING THE SUBCLAVIEN VEIN IN PREPARATION FOR PROBE INSERTION FOR THE CRT-D SYSTEM, A PNEUMOTHORAX OCCURRED. A PLEURAL DRAINAGE WAS ADMINISTERED TO STABILIZE THE PATIENT.

  Patient problems: Pneumothorax

  MAUDE report 8429954 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2018-00423. 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 8071346 ↗