ETHICON TPW20Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705031050877), received between May 8, 2019 and Mar 30, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Material Separation” (26 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE PRODUCT WAS SPLITTING. CV PACK THE SUTURE BOOTS WERE BREAKING/SPLITTING IN HALF, UNSAFE WHILE WORKING IN AN OPEN CHEST CAVITY. PACING WIRES- WERE SPLITTING. THE SCRUB TECH REMOVED THE DEFECTIVE ITEMS, ENSURED THE PATIENT WASN'T HARMED, DISCUSSED WITH THE SURGEON AND ESCALATED TO TEAM LEADER. DEVICES ARE NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729544 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE PRODUCT WAS SPLITTING. CV PACK THE SUTURE BOOTS WERE BREAKING/SPLITTING IN HALF, UNSAFE WHILE WORKING IN AN OPEN CHEST CAVITY. PACING WIRES- WERE SPLITTING. THE SCRUB TECH REMOVED THE DEFECTIVE ITEMS, ENSURED THE PATIENT WASN'T HARMED, DISCUSSED WITH THE SURGEON AND ESCALATED TO TEAM LEADER. DEVICES ARE NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728036 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE PRODUCT WAS SPLITTING. CV PACK THE SUTURE BOOTS WERE BREAKING/SPLITTING IN HALF, UNSAFE WHILE WORKING IN AN OPEN CHEST CAVITY. PACING WIRES- WERE SPLITTING. THE SCRUB TECH REMOVED THE DEFECTIVE ITEMS, ENSURED THE PATIENT WASN'T HARMED, DISCUSSED WITH THE SURGEON AND ESCALATED TO TEAM LEADER. DEVICES ARE NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727929 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE PRODUCT WAS SPLITTING. CV PACK THE SUTURE BOOTS WERE BREAKING/SPLITTING IN HALF, UNSAFE WHILE WORKING IN AN OPEN CHEST CAVITY. PACING WIRES- WERE SPLITTING. THE SCRUB TECH REMOVED THE DEFECTIVE ITEMS, ENSURED THE PATIENT WASN'T HARMED, DISCUSSED WITH THE SURGEON AND ESCALATED TO TEAM LEADER. DEVICES ARE NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727294 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE PRODUCT WAS SPLITTING. CV PACK THE SUTURE BOOTS WERE BREAKING/SPLITTING IN HALF, UNSAFE WHILE WORKING IN AN OPEN CHEST CAVITY. PACING WIRES- WERE SPLITTING. THE SCRUB TECH REMOVED THE DEFECTIVE ITEMS, ENSURED THE PATIENT WASN'T HARMED, DISCUSSED WITH THE SURGEON AND ESCALATED TO TEAM LEADER. DEVICES ARE NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727278 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE PRODUCT WAS SPLITTING. CV PACK THE SUTURE BOOTS WERE BREAKING/SPLITTING IN HALF, UNSAFE WHILE WORKING IN AN OPEN CHEST CAVITY. PACING WIRES- WERE SPLITTING. THE SCRUB TECH REMOVED THE DEFECTIVE ITEMS, ENSURED THE PATIENT WASN'T HARMED, DISCUSSED WITH THE SURGEON AND ESCALATED TO TEAM LEADER. DEVICES ARE NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727245 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE PRODUCT WAS SPLITTING. CV PACK THE SUTURE BOOTS WERE BREAKING/SPLITTING IN HALF, UNSAFE WHILE WORKING IN AN OPEN CHEST CAVITY. PACING WIRES- WERE SPLITTING. THE SCRUB TECH REMOVED THE DEFECTIVE ITEMS, ENSURED THE PATIENT WASN'T HARMED, DISCUSSED WITH THE SURGEON AND ESCALATED TO TEAM LEADER. DEVICES ARE NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727240 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE PRODUCT WAS SPLITTING. CV PACK THE SUTURE BOOTS WERE BREAKING/SPLITTING IN HALF, UNSAFE WHILE WORKING IN AN OPEN CHEST CAVITY. PACING WIRES- WERE SPLITTING. THE SCRUB TECH REMOVED THE DEFECTIVE ITEMS, ENSURED THE PATIENT WASN'T HARMED, DISCUSSED WITH THE SURGEON AND ESCALATED TO TEAM LEADER. DEVICES ARE NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727107 ↗
• MalfunctionJan 20, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE DEVICE PACKAGE WAS FOUND UNSEALED WHEN UNPACKING AND COUNTING. ONE END OF THE PACKAGE IS NOT SEALED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119570 ↗
• MalfunctionDec 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHEN PREPARING FOR USE BEFORE SURGERY, IT WAS FOUND THAT THE SUTURE IS PRESSED ONTO THE PACKAGING EDGE. 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 23898583 ↗
• MalfunctionJun 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359513 ↗
• MalfunctionJun 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338569 ↗
• MalfunctionJun 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USING FOR MONITORING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630645 ↗
• MalfunctionJun 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STOP JUMPING AND BUILD A BRIDGE PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USING FOR MONITORING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630634 ↗
• MalfunctionJun 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRICUSPID VALVE RECONSTRUCTION SURGERY PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USING FOR MONITORING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630620 ↗
• MalfunctionJun 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USING FOR MONITORING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630612 ↗
• MalfunctionJun 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USING FOR MONITORING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630611 ↗
• MalfunctionJun 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CONTINUOUSLY JUMPING AND BUILDING BRIDGES PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USING FOR MONITORING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630580 ↗
• MalfunctionJun 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CONTINUOUSLY JUMPING AND BUILDING BRIDGES PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USING FOR MONITORING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630578 ↗
• MalfunctionJul 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USE FOR MONITORING. CHANGED TO ANOTHER TWO TO CONTINUE THE CARDIAC SURGERY, AND THE SAME PROBLEM HAPPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17417688 ↗
• MalfunctionJul 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USE FOR MONITORING. CHANGED TO ANOTHER TWO TO CONTINUE THE CARDIAC SURGERY, AND THE SAME PROBLEM HAPPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17417673 ↗
• MalfunctionJul 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USE FOR MONITORING. CHANGED TO ANOTHER TWO TO CONTINUE THE CARDIAC SURGERY, AND THE SAME PROBLEM HAPPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17417646 ↗
• MalfunctionJul 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BYPASS PROCEDURE ON (B)(6) 2023 AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17331833 ↗
• MalfunctionJul 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BYPASS PROCEDURE ON (B)(6) 2023 AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17331830 ↗
• MalfunctionJul 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BYPASS PROCEDURE ON (B)(6) 2023 AND TEMPORARY PACING WIRE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE (STRAIGHT NEEDLE) OCCURRED DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17331825 ↗