ETHICON TPW32Recalls & reported problems
Ethicon, LLC · Temporary Cardiac Pacing Wire · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon temporary cardiac pacing wire is used to keep a patient's heart beating at a controlled rate during surgery or recovery. Most of the 46 reports describe the wire breaking or separating when it was being taken out, sometimes leaving a small fragment behind, and patients mentioned bleeding around the heart, irregular rhythms, or cardiac arrest. The reports include 1 death and 11 injuries. No recalls name this device, and no new reports have been filed in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 1
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705031050891), received between Apr 12, 2018 and Jan 29, 2024 — classified as 1 death, 11 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Break” (31 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.
Reports received per month
Most reported problems
Device problems
- Break31
- Material Separation8
- Adverse Event Without Identified Device or Use Problem6
- Pacing Inadequately1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Cardiac Tamponade5
- Hemorrhage/Blood Loss/Bleeding5
- Arrhythmia3
- Cardiac Arrest2
- No Consequences Or Impact To Patient2
- Atrial Fibrillation1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2024Break; Pacing Inadequately; Break; Pacing Inadequately
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, TPW32 PACING WIRE NOT FUNCTIONING- UPON ATTEMPTED REMOVAL BY NURSE WIRE BROKE, ONLY PARTIALLY CAME OUT. SEE REPORT. IMAGE ATTACHED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18596032 ↗DeathOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND A TEMPORARY PACING WIRE WAS INSERTED. POST-OPERATIVELY, THE PATIENT WAS IN SINUS RHYTHM THE ENTIRE TIME, ALL WAS WELL WHEN HE CAME OUT OF THE ICU, WITH ALL THE RIGHT SETTINGS. ON THE WARD, IT WAS NOT SENSING THE RIGHT RHYTHM AND WAS PACING INAPPROPRIATELY WHICH LEAD TO HIS R ON T AND THEN TO VF AND TO HIS DEATH. THE PATIENT PASSED DUE TO UNRECOGNIZED R ON T. UPON OPENING AND INSPECTING THE WIRES, THEY DID NOT LOOK DEFECTIVE OR THAT THERE WAS ANYTHING WRONG WITH THEM. THE SURGEON ALSO ADDED THAT EVEN AT THE MOST SENSITIVE SETTING OF THE DEVICE, IT'S NOT SENSING PROPERLY. SHE ALSO EXPRESSED SOME WORDS ON TELEMETRY READINGS: "COMPETENCE IN THE TELEMETRY READING BY THE NURSES OR FAILURE TO DO PROPER TELEMETRY READING, WHERE THEY WEREN'T ABLE TO PICK UP THE ALERT SIGNAL." ADDITIONAL NOTES FROM THE SURGEON: "I FIND THE ETHICON WIRES TO BE ROUGH, THE EDGES ARE ROUGH AND THEY FRAY. BUT BECAUSE THERE IS AN IMPRESSION AMONGST THE SURGEON GROUP THAT THE ETHICON WIRES CAUSE INCREASED BLEEDING, WE NEED TO LOOK AT EVERYTHING." THEREAFTER, SHE ALSO STATED: "BECAUSE THE SURGEON GROUP HAS AN IMPRESSION THA
Patient problems: Ventricular Fibrillation
MAUDE report 15640627 ↗MalfunctionSep 2, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. THE PHYSICIAN¿S ASSISTANT STATED THAT THEY RECENTLY HAD A SMALL FRAGMENT OF A WIRE REMAIN FOLLOWING A PACING WIRE PULL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Foreign Body In Patient
MAUDE report 15349109 ↗InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TEMPORARY PACING WIRE PLACEMENT PROCEDURE ON AN UNKNOWN DATE. THE SURGEON STATED THEY RECENTLY SWITCHED TO THIS KIND OF TEMPORARY PACING WIRES. THE PATIENT EXPERIENCED DELAYED TAMPONADE, PRESUMABLY RELATED TO REMOVAL OF THE WIRE. WHILE OBVIOUSLY IT IS DIFFICULT TO KNOW FOR CERTAIN IF THE LEADS ARE THE CAUSE, THE ONSET OF A PREVIOUSLY RARE EVENT COINCIDING WITH THE ADOPTION OF THE NEW LEADS CANNOT BE IGNORED. THE PACER WIRE WAS REMOVED FOUR OR FIVE DAYS FOLLOWING SURGERY WHILE THE PATIENT IS ON THE WARD AND JUST PRIOR TO DISCHARGE HOME. THE PATIENT HAD BLEEDING THE DAY FOLLOWING REMOVAL OF THE WIRES. THE BLEEDING IS CAUSED BY BLEEDING FROM EPICARDIAL VESSELS ON THE HEART RELATED TO TRAUMA FROM REMOVING THE PACER WIRE. THE BLEEDING IS CONTAINED WITHIN THE PERICARDIAL SPACING AND CAUSED TAMPONADE NECESSITATING A TAKE BACK FOR BLEEDING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding
MAUDE report 15086166 ↗InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TEMPORARY PACING WIRE PLACEMENT PROCEDURE ON AN UNKNOWN DATE. THE SURGEON STATED THEY RECENTLY SWITCHED TO THIS KIND OF TEMPORARY PACING WIRES. THE PATIENT EXPERIENCED DELAYED TAMPONADE, PRESUMABLY RELATED TO REMOVAL OF THE WIRE. WHILE OBVIOUSLY IT IS DIFFICULT TO KNOW FOR CERTAIN IF THE LEADS ARE THE CAUSE, THE ONSET OF A PREVIOUSLY RARE EVENT COINCIDING WITH THE ADOPTION OF THE NEW LEADS CANNOT BE IGNORED. THE PACER WIRE WAS REMOVED FOUR OR FIVE DAYS FOLLOWING SURGERY WHILE THE PATIENT IS ON THE WARD AND JUST PRIOR TO DISCHARGE HOME. THE PATIENT HAD BLEEDING THE DAY FOLLOWING REMOVAL OF THE WIRES. THE BLEEDING IS CAUSED BY BLEEDING FROM EPICARDIAL VESSELS ON THE HEART RELATED TO TRAUMA FROM REMOVING THE PACER WIRE. THE BLEEDING IS CONTAINED WITHIN THE PERICARDIAL SPACING AND CAUSED TAMPONADE NECESSITATING A TAKE BACK FOR BLEEDING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding
MAUDE report 15086150 ↗InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TEMPORARY PACING WIRE PLACEMENT PROCEDURE ON AN UNKNOWN DATE. THE SURGEON STATED THEY RECENTLY SWITCHED TO THIS KIND OF TEMPORARY PACING WIRES. THE PATIENT EXPERIENCED DELAYED TAMPONADE, PRESUMABLY RELATED TO REMOVAL OF THE WIRE. WHILE OBVIOUSLY IT IS DIFFICULT TO KNOW FOR CERTAIN IF THE LEADS ARE THE CAUSE, THE ONSET OF A PREVIOUSLY RARE EVENT COINCIDING WITH THE ADOPTION OF THE NEW LEADS CANNOT BE IGNORED. THE PACER WIRE WAS REMOVED FOUR OR FIVE DAYS FOLLOWING SURGERY WHILE THE PATIENT IS ON THE WARD AND JUST PRIOR TO DISCHARGE HOME. THE PATIENT HAD BLEEDING THE DAY FOLLOWING REMOVAL OF THE WIRES. THE BLEEDING IS CAUSED BY BLEEDING FROM EPICARDIAL VESSELS ON THE HEART RELATED TO TRAUMA FROM REMOVING THE PACER WIRE. THE BLEEDING IS CONTAINED WITHIN THE PERICARDIAL SPACING AND CAUSED TAMPONADE NECESSITATING A TAKE BACK FOR BLEEDING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding
MAUDE report 15086145 ↗InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TEMPORARY PACING WIRE PLACEMENT PROCEDURE ON AN UNKNOWN DATE. THE SURGEON STATED THEY RECENTLY SWITCHED TO THIS KIND OF TEMPORARY PACING WIRES. THE PATIENT EXPERIENCED DELAYED TAMPONADE, PRESUMABLY RELATED TO REMOVAL OF THE WIRE. WHILE OBVIOUSLY IT IS DIFFICULT TO KNOW FOR CERTAIN IF THE LEADS ARE THE CAUSE, THE ONSET OF A PREVIOUSLY RARE EVENT COINCIDING WITH THE ADOPTION OF THE NEW LEADS CANNOT BE IGNORED. THE PACER WIRE WAS REMOVED FOUR OR FIVE DAYS FOLLOWING SURGERY WHILE THE PATIENT IS ON THE WARD AND JUST PRIOR TO DISCHARGE HOME. THE PATIENT HAD BLEEDING THE DAY FOLLOWING REMOVAL OF THE WIRES. THE BLEEDING IS CAUSED BY BLEEDING FROM EPICARDIAL VESSELS ON THE HEART RELATED TO TRAUMA FROM REMOVING THE PACER WIRE. THE BLEEDING IS CONTAINED WITHIN THE PERICARDIAL SPACING AND CAUSED TAMPONADE NECESSITATING A TAKE BACK FOR BLEEDING. THIS IN FACT IT HAPPENED LAST WEEK AND THE SITE OF THE PACER WIRE WAS OBVIOUS WITH BLEEDING ARISING FROM THE INFERIOR SURFACE OF THE HEART WHICH ARE REQUIRED TO CONTROL WITH A SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding
MAUDE report 15086120 ↗InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TEMPORARY PACING WIRE PLACEMENT PROCEDURE ON AN UNKNOWN DATE. THE SURGEON STATED THEY RECENTLY SWITCHED TO THIS KIND OF TEMPORARY PACING WIRES. THE PATIENT EXPERIENCED DELAYED TAMPONADE, PRESUMABLY RELATED TO REMOVAL OF THE WIRE. WHILE OBVIOUSLY IT IS DIFFICULT TO KNOW FOR CERTAIN IF THE LEADS ARE THE CAUSE, THE ONSET OF A PREVIOUSLY RARE EVENT COINCIDING WITH THE ADOPTION OF THE NEW LEADS CANNOT BE IGNORED. THE PACER WIRE WAS REMOVED FOUR OR FIVE DAYS FOLLOWING SURGERY WHILE THE PATIENT IS ON THE WARD AND JUST PRIOR TO DISCHARGE HOME. THE PATIENT HAD BLEEDING THE DAY FOLLOWING REMOVAL OF THE WIRES. THE BLEEDING IS CAUSED BY BLEEDING FROM EPICARDIAL VESSELS ON THE HEART RELATED TO TRAUMA FROM REMOVING THE PACER WIRE. THE BLEEDING IS CONTAINED WITHIN THE PERICARDIAL SPACING AND CAUSED TAMPONADE NECESSITATING A TAKE BACK FOR BLEEDING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding
MAUDE report 15086105 ↗MalfunctionFeb 25, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TEMPORARY EPICARDIAL PACING ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WAS FRAYING/FRACTURE AT THE POINT WHERE THE FLEXIBLE PACING WIRE MEETS THE RIGID METAL PIN. FLEXIBLE PACING WIRE BECAME COMPLETELY DISCONNECTED FROM METAL PIN (PORTION WHERE PACING WIRES CONNECT TO CABLES THAT CONNECT TO PACING BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13607906 ↗MalfunctionFeb 25, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TEMPORARY EPICARDIAL PACING ON (B)(6) 2021 AND TEMPORARY CARDIAC PACING WIRE WAS USED. DURING THE PROCEDURE, THERE WAS FRAYING/FRACTURE AT THE POINT WHERE THE FLEXIBLE PACING WIRE MEETS THE RIGID METAL PIN. FLEXIBLE PACING WIRE BECAME COMPLETELY DISCONNECTED FROM METAL PIN (PORTION WHERE PACING WIRES CONNECT TO CABLES THAT CONNECT TO PACING BOX). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13607666 ↗MalfunctionOct 8, 2021Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE FRACTURED AT THE JUNCTION OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12599362 ↗MalfunctionOct 8, 2021Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE FRACTURED AT THE JUNCTION OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12599361 ↗MalfunctionOct 8, 2021Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE FRACTURED AT THE JUNCTION OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12599358 ↗MalfunctionOct 8, 2021Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE FRACTURED AT THE JUNCTION OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12599355 ↗MalfunctionOct 8, 2021Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE FRACTURED AT THE JUNCTION OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12599354 ↗MalfunctionOct 8, 2021Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE FRACTURED AT THE JUNCTION OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12599352 ↗MalfunctionOct 8, 2021Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE FRACTURED AT THE JUNCTION OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12599346 ↗MalfunctionOct 8, 2021Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE WIRE FRACTURED AT THE JUNCTION OF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12599343 ↗MalfunctionSep 15, 2021Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A FONTAN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. POST-OPERATIVELY, IT WAS REPORTED THAT THE SUTURE BROKE. PATIENT HAD TPW32 INSERTED ON (B)(6) 2021. THE PATIENT WAS PACED FROM (B)(6). REQUIRED HIGH MA ON ATRIAL SIDE (18 MA). PACER TURNED OFF AND REMOVED BRIDGING CABLES. AFTER HCP'S INSPECTED, THEY FOUND PINS A FEW HOURS LATER BROKEN FROM TPW32 WIRES. HCP'S WERE ABLE TO DISCONTINUE PACING WITHOUT ANY FURTHER NEED. PATIENT IS RECOVERING WELL. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12475320 ↗MalfunctionAug 25, 2021Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. POST-OPERATIVELY, IT WAS REPORTED THAT THE SUTURE BROKE. PATIENT HAD TPW32 INSERTED ON (B)(6) 2021. THE PATIENT WAS PACED FROM 7/21-7/24. REQUIRED HIGH MA ON ATRIAL SIDE (18 MA). PACER TURNED OFF AND REMOVED BRIDGING CABLES. AFTER HCP'S INSPECTED, THEY FOUND PINS A FEW HOURS LATER BROKEN FROM TPW32 WIRES. HCP'S WERE ABLE TO DISCONTINUE PACING WITHOUT ANY FURTHER NEED. PATIENT IS RECOVERING WELL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12367200 ↗MalfunctionAug 20, 2021Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. POST-OPERATIVELY, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12350227 ↗MalfunctionAug 20, 2021Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. POST-OPERATIVELY, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12350172 ↗MalfunctionAug 6, 2021Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. THE WIRE FRACTURED AT THE JUNCTION OF THE METAL BLUNT NEEDLE AND WIRE. DUE TO THE ISSUE, THERE WAS DELAY IN BEING ABLE TO CARDIAC PACE THE PATIENT, HOWEVER, THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12287877 ↗MalfunctionAug 6, 2021Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TEMPORARY PACING WIRE WAS USED. THE WIRE FRACTURED AT THE JUNCTION OF THE METAL BLUNT NEEDLE AND WIRE. DUE TO THE ISSUE, THERE WAS DELAY IN BEING ABLE TO CARDIAC PACE THE PATIENT, HOWEVER, THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12287868 ↗MalfunctionJul 30, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC SURGERY ON UNKNOWN DATE IN 2021 AND THE TEMPORARY PACING WIRE WAS PLACED. IT WAS REPORTED THAT THE CARDIAC PACING WIRE FRACTURED AT THE JUNCTURE OF THE NEEDLE AND THE WIRE. THIS EVENT OCCURRED WHEN THE PATIENT WAS BROUGHT TO THE ICU. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12250855 ↗
Other ELECTRODE, PACEMAKER, TEMPORARY devices
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- ETHICON TPW20Ethicon, LLC · ELECTRODE, PACEMAKER, TEMPORARY39 reports
- N/A 520007PC. R. Bard, Inc. · ELECTRODE, PACEMAKER, TEMPORARY33 reports
- Pacel™ 401763St. Jude Medical Cardiovascular Division · ELECTRODE, PACEMAKER, TEMPORARY21 reports
- Pacel™ 401771St. Jude Medical Cardiovascular Division · ELECTRODE, PACEMAKER, TEMPORARY1 death16 reports
- SWAN-GANZ PACING TD CATHETER D205F7Edwards Lifesciences LLC · Electrode, Pacemaker, Temporary13 reports
- ETHICON TPW10Ethicon, LLC · ELECTRODE, PACEMAKER, TEMPORARY12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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