ETHICON TPW30Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031050884), received between Feb 9, 2018 and May 27, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT IT WAS FOUND THAT THERE HAD BEEN FOREIGN MATTER (AS THE PHOTO SHOWS) IMMEDIATELY ONCE OPENED THE PACKAGE WHEN PREPARING FOR SURGERY . 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 25299342 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAD BEEN FOUND BROKEN IN THE NEWLY DISPENSED SUTURE WHEN PREPARING FOR SURGERY. 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 22646885 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE HOSPITAL HAS NOTICED THE TPW30 PACING WIRE 2-0 WIRES BREAKING MORE THAN USUAL. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997364 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE HOSPITAL HAS NOTICED THE TPW30 PACING WIRE 2-0 WIRES BREAKING MORE THAN USUAL. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994829 ↗
• MalfunctionSep 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17828665 ↗
• MalfunctionApr 26, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE HOSPITAL HAS REPORTED THAT THE SURGEON WAS INSERTING THE TEMPORARY CARDIAC PACING WIRE INTO THE PATIENT AND THE TIP OF THE BREAKAWAY NEEDLE SNAPPED OFF IN THE PATIENT (BOTTOM LEFT HAND SIDE OF THE STERNUM) ON BOTH WIRES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14212879 ↗
• MalfunctionJul 8, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT IN A VERY SEVERE CONDITION UNDERWENT A BENTALL SURGERY ON (B)(6) 2021 AND THE TEMPORARY PACING WIRE WAS PLACED OVER THE RA/ATRIUM AND RV/VENTRICLE AND CONNECTED TO THE GENERATOR FOR PACING. THE POSTOPERATIVE CONDITION WAS POOR, AND IT BECAME LONG-TERM PACING MANAGEMENT. ON (B)(6) 2021, AFTER AN X-RAY, A RUPTURE OCCURRED AT THE CONNECTION PART BETWEEN THE PACING WIRE AND STRAIGHT NEEDLE THAT WAS CONNECTED TO THE GENERATOR. THERE WAS TIME WHEN PACING COULD NOT BE PERFORMED TEMPORARILY DUE TO RUPTURE AND A SURGEON PEELED OFF THE POLYETHYLENE COATING AND RECONNECTED TO THE GENERATOR. IT WAS ALSO REPORTED THAT THE PATIENT SUBSEQUENTLY DIED ON (B)(6) 2021. THE DOCTOR COMMENTED THAT THE CAUSAL RELATIONSHIP BETWEEN PRODUCT/EVENT WITH THE DEATH WAS COMPLETELY UNRELATED. THE REASON WAS THAT ALL PACING WAS PERFORMED WITH PERMANENT PACEMAKER VVI AND THE RATE WAS 90. EVEN IF THE TEMPORARY PACING WIRE WAS TORN, THE RATE WAS ABOUT 60, WHICH DOES NOT MEAN THAT THE RATE HAS DECREASED EXTREMELY. ALSO OTHER CONTRIBUTED FACTOR WAS THAT THE PATIENT WAS ORIGINALLY IN A VERY SEVERE CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12139930 ↗
• MalfunctionJun 19, 2018Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND A TEMPORARY PACING WIRE WAS USED. DURING REFURBISHING OF THE TEMPORARY PACING WIRE, IT WAS DETECTED THE BOX HAD NO INSERT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAD BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7614790 ↗
• MalfunctionFeb 20, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG AND MITRAL VALVE REPLACEMENT PROCEDURES ON (B)(6) 2018 AND PACING WIRE WAS USED. DURING THE PROCEDURE, THE PACING WIRE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE NEEDLE DID NOT FALL INTO THE PATIENT AND THE PATIENT DID NOT REQUIRE FURTHER TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7282827 ↗
• MalfunctionFeb 9, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CABG AND VALVE REPLACEMENT PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE SEPARATED FROM THE NEEDLE DURING USE. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7260833 ↗