ETHICON TPW10Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031050860), received between Jul 18, 2018 and Aug 22, 2024 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND A TEMPORARY PACING WIRE WAS PLACED. DURING ROUTINE CARE ON (B)(6) 2021, THE PACING WIRE SNAPPED DURING PACING AT THE POINT WHERE THERE THE WIRE MEETS THE METAL PIN, WHICH RESULTED IN NO PACING FOR PERIOD OF TIME UNTIL REATTACHED. THE WIRE WAS RE-ATTACHED AS QUICKLY AS POSSIBLE. THE WIRE WAS STRIPPED OF THE PLASTIC COVERING TO EXPOSE THE METAL CORE WHICH WAS THEN INSERTED INTO THE PACING BOX TO ENABLE PACING TO BE RE-ESTABLISHED. AN ALTERNATIVE SUPPLIER OF PACING WIRE WAS USED. THERE WAS NO OBVIOUS REASON FOR THE WIRE TO SNAP. THERE WAS NO PATIENT HARM, HOWEVER LOTS OF STRESS AND ANXIETY FOR ALL CONCERNED, BUT NO INJURY TO PATIENT. THE PATIENT WAS DISCHARGED FOLLOWING THIS EPISODE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20040812 ↗
• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE VERY FRAGILE WIRE BREAKS EASILY, AND IT IS NOT POSSIBLE TO CONNECT TO THE PACEMAKER GENERATOR. THE HOSPITAL HAS 21 UNITS IN STOCK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399927 ↗
• MalfunctionJun 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING A PACEMAKER REWIRING UPON ASSESSMENT OF ATRIAL ELECTRIC PLUGS THE PRODUCT WAS FOUND TO BE BROKEN OFF INSIDE PATIENT CABLE PLUG. THE PATIENT WIRE HAD TO BE STRIPPED AND REWIRED TO CONNECT BACK TO PACER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14777645 ↗
• InjuryApr 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVSD REPAIR PROCEDURE ON (B)(6) 2021 AND A TEMPORARY PACING WIRE WAS USED. THE PACING WIRES INSERTED BECAUSE THE HEART WAS SWELLED. ON (B)(6) 2021, THE PATIENT HAS WIRED STITCHED TO THEIR SKIN, PATIENT KICKED THE WIRE AND THE WIRE SNAPPED AT THE ROD (THE POINT WHERE IT JOINS THE BOX) BECAUSE BOX IS PLACED NEAR PATIENTS¿ BED, WHICH LEAD TO CARDIAC ARREST. CPR NEEDED. THE ROD SNAPPED OFF - THE PLASTIC-COATED WIRES JOIN THE ROD (ROD BECOMES USELESS), WIRES NEEDED TO BE STRIPPED TO ENABLE THE WIRES TO ATTACH TO THE METAL WITHIN THE BOX TO GET CONTACT. ON (B)(6) 2021, KICKED OUT AGAIN, DETACHES WIRES AGAIN, PATIENT DIDN¿T NEED CPR BUT HEARTRATE DID FALL. VERY CLOSE TO CPR BEING REQUIRED, BLOOD PRESSURE DID MAINTAIN AND CPR NOT NEEDED. WIRES WEAK AT PACING BOX JOIN, SNAPPED 3 TIMES AT THIS POINT. THIS INCIDENT PATIENT KICKED WIRES LOSE AND BOX PLACED BETWEEN PATIENT¿S LEGS. ON (B)(6) 2021, THE PACEMAKER HAD TO BE FITTED. IT WAS NOT SURE IF THE PATIENT WOULD HAVE HAD PACEMAKER FITTED ANY WAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 14104231 ↗
• InjuryApr 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVSD REPAIR PROCEDURE ON (B)(6)2021 AND A TEMPORARY PACING WIRE WAS USED. THE PACING WIRES INSERTED BECAUSE THE HEART WAS SWELLED. ON (B)(6)2021, THE PATIENT HAS WIRED STITCHED TO THEIR SKIN, PATIENT KICKED THE WIRE AND THE WIRE SNAPPED AT THE ROD (THE POINT WHERE IT JOINS THE BOX) BECAUSE BOX IS PLACED NEAR PATIENTS¿ BED, WHICH LEAD TO CARDIAC ARREST. CPR NEEDED. THE ROD SNAPPED OFF - THE PLASTIC-COATED WIRES JOIN THE ROD (ROD BECOMES USELESS), WIRES NEEDED TO BE STRIPPED TO ENABLE THE WIRES TO ATTACH TO THE METAL WITHIN THE BOX TO GET CONTACT. ON (B)(6)2021, KICKED OUT AGAIN, DETACHES WIRES AGAIN, PATIENT DIDN¿T NEED CPR BUT HEARTRATE DID FALL. VERY CLOSE TO CPR BEING REQUIRED, BLOOD PRESSURE DID MAINTAIN AND CPR NOT NEEDED. WIRES WEAK AT PACING BOX JOIN, SNAPPED 3 TIMES AT THIS POINT. THIS INCIDENT PATIENT KICKED WIRES LOSE AND BOX PLACED BETWEEN PATIENT¿S LEGS. ON (B)(6)2021, THE PACEMAKER HAD TO BE FITTED. IT WAS NOT SURE IF THE PATIENT WOULD HAVE HAD PACEMAKER FITTED ANY WAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 14104227 ↗
• InjuryApr 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVSD REPAIR PROCEDURE ON (B)(6) 2021 AND A TEMPORARY PACING WIRE WAS USED. THE PACING WIRES INSERTED BECAUSE THE HEART WAS SWELLED. ON (B)(6) 2021, THE PATIENT HAS WIRED STITCHED TO THEIR SKIN, PATIENT KICKED THE WIRE AND THE WIRE SNAPPED AT THE ROD (THE POINT WHERE IT JOINS THE BOX) BECAUSE BOX IS PLACED NEAR PATIENTS¿ BED, WHICH LEAD TO CARDIAC ARREST. CPR NEEDED. THE ROD SNAPPED OFF - THE PLASTIC-COATED WIRES JOIN THE ROD (ROD BECOMES USELESS), WIRES NEEDED TO BE STRIPPED TO ENABLE THE WIRES TO ATTACH TO THE METAL WITHIN THE BOX TO GET CONTACT. ON (B)(6) 2021, KICKED OUT AGAIN, DETACHES WIRES AGAIN, PATIENT DIDN¿T NEED CPR BUT HEARTRATE DID FALL. VERY CLOSE TO CPR BEING REQUIRED, BLOOD PRESSURE DID MAINTAIN AND CPR NOT NEEDED. WIRES WEAK AT PACING BOX JOIN, SNAPPED 3 TIMES AT THIS POINT. THIS INCIDENT PATIENT KICKED WIRES LOSE AND BOX PLACED BETWEEN PATIENT¿S LEGS. ON (B)(6) 2021, THE PACEMAKER HAD TO BE FITTED. IT WAS NOT SURE IF THE PATIENT WOULD HAVE HAD PACEMAKER FITTED ANY WAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 14104226 ↗
• MalfunctionOct 1, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. POST OP, IN ICU, THE WIRE BROKE AT THE POINT WHERE THE ELECTRODE CONNECTOR JOINS THE WIRE AT THE DISTAL END. FORTUNATELY, THE PATIENT WAS ASSESSED AND IT WAS DECIDED THAT THERE WAS NO NEED TO PLACE ANOTHER TEMPORARY PACING WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566207 ↗
• MalfunctionOct 1, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. POST OP, IN ICU, THE WIRE BROKE AT THE POINT WHERE THE ELECTRODE CONNECTOR JOINS THE WIRE AT THE DISTAL END. FORTUNATELY, THE PATIENT WAS ASSESSED AND IT WAS DECIDED THAT THERE WAS NO NEED TO PLACE ANOTHER TEMPORARY PACING WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565509 ↗
• MalfunctionOct 1, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND TEMPORARY PACING WIRE WAS USED. POST OP, IN THE THEATRE, AT THE END OF THE PROCEDURE, THE WIRE BROKE AT THE POINT WHERE THE ELECTRODE CONNECTOR JOINS THE WIRE AT THE DISTAL END. FORTUNATELY, THE PATIENT WAS ASSESSED AND IT WAS DECIDED THAT THERE WAS NO NEED TO PLACE ANOTHER TEMPORARY PACING WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565500 ↗
• MalfunctionOct 1, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. POST OP, IN ICU, THE WIRE BROKE AT THE POINT WHERE THE ELECTRODE CONNECTOR JOINS THE WIRE AT THE DISTAL END. FORTUNATELY, THE PATIENT WAS ASSESSED AND IT WAS DECIDED THAT THERE WAS NO NEED TO PLACE ANOTHER TEMPORARY PACING WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565493 ↗
• MalfunctionSep 12, 2018Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED A PATIENT UNDERWENT A VALVE EXCHANGE PROCEDURE ON (B)(6) 2018 WHERE TEMPORARY PACING WIRE WAS USED. THE NEEDLE WAS PASSING THROUGH THE PACKAGE. PRODUCT WAS NOT USED IN THE PATIENT. ANOTHER THREAD WAS USED. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7868373 ↗
• MalfunctionJul 18, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND A TEMPORARY PACING WIRE WAS USED. PRIOR TO USING ON THE PATIENT, IT WAS NOTICED THAT THE TIP OF THE NEEDLE WAS EXPOSED THROUGH THE PACKAGE. IT WAS NOT USED IN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7700265 ↗