ETHICON TPW42Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031050914), received between Jan 25, 2022 and Mar 20, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC SURGERY ON (B)(6) 2026, AND TEMPORARY PACING WIRE WAS USED. DURING THE SUTURE CONNECTION PROCESS IN THE CARDIAC SURGERY, THE SUTURE BROKE AND THEN IT IS UNABLE TO CONDUCT ELECTRICITY AND CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651220 ↗
• MalfunctionJul 21, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE HAS COME OUT OF THE PIN THAT GOES INTO THE PACER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080915 ↗
• MalfunctionJul 21, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE HAS COME OUT OF THE PIN THAT GOES INTO THE PACER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080905 ↗
• MalfunctionJul 21, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE HAS COME OUT OF THE PIN THAT GOES INTO THE PACER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080903 ↗
• MalfunctionJul 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE FIRST PASS THROUGH THE SKIN THE LIGHT BLUE WIRE POPPED OFF AT THE SWAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048648 ↗
• MalfunctionJul 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE FIRST PASS THROUGH THE SKIN THE LIGHT BLUE WIRE POPPED OFF AT THE SWAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048580 ↗
• MalfunctionJul 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, ON THE FIRST PASS THROUGH THE SKIN THE LIGHT BLUE WIRE POPPED OFF AT THE SWAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048491 ↗
• InjuryJan 25, 2022Break; Break

  IT WAS REPORTED THAT AN INFANT UNDERWENT AN UNKNOWN OPEN-HEART PROCEDURE ON (B)(6) 2021 AND A TEMPORARY PACING WIRE WAS USED. TWO WEEKS POST-OP, WITH PATIENT STILL IN THE HOSPITAL, THE METAL TABS BROKE OFF OF THE PACING WIRES REQUIRING STAFF TO DO MANUAL CHEST COMPRESSIONS TILL AN EXTERNAL DEFIBRILLATOR WAS AVAILABLE TO REVIVE THE PATIENT. DUE TO COMPLICATION OF THE PACING WIRES, THE PATIENT'S SCHEDULED PACEMAKER PROCEDURE WAS CONVERTED FROM PARTIAL TO FULL STERNOTOMY TO INSERT PACEMAKER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13342867 ↗