TB 020022Recalls & reported problems
Oscor Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836559009900), received between Sep 10, 2018 and Sep 10, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K861403); they may or may not involve this specific model.
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 16, 2026.
Most reported problems
Device problems
- Electrical /Electronic Property Problem1
- Loose or Intermittent Connection1
Patient problems
- Complete Heart Block1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2018Electrical /Electronic Property Problem; Loose or Intermittent Connection; Electrical /Electronic Property Problem; Loose or Intermittent Connection
THE CUSTOMER REPORTED THE SONDE (CATHETER) PLUG HAD A LOOSE CONNECTION AND AS A RESULT THE PATIENT HAD TO BE RESUSCITATED. WITH THESE SONDES A COUPLE PROBLEMS OCCUR THAT THREATEN THE LIFE OF THE PATIENT. IN ADDITION THERE IS A LOOSE CONNECTION AT THE PLUG, SO THERE IS NO STIMULATION. THIS IS WHAT HAPPENED TODAY IN THE IMC. THE PATIENT CAME WITH THE AV BLOCK III°, CAME DIRECTLY FROM THE EMERGENCY DEPARTMENT TO THE CATH LAB, IMMEDIATELY RECEIVED THE TEMPORARY PACEMAKER AND IN SPITE OF THE CORRECT POSITION OF THE SONDE (CATHETER) THE PATIENT HAD TO BE RESUSCITATED IN THE IMC AND AN EXTERNAL STIMULATION BY A DEFIBRILLATOR WAS NECESSARY. IT TURNED OUT THAT THERE WAS A LOOSE CONNECTION OF THE PLUG.
Patient problems: Complete Heart Block
MAUDE report 7861685 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K861403. One submission often covers many models, so check the product and lot details in each record.
- Z-0391-2019 · Sep 26, 2018 · TerminatedTB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray
Other Electrode, Pacemaker, Temporary devices
- N/A 006173PC. R. Bard, Inc. · ELECTRODE, PACEMAKER, TEMPORARY161 reports
- SWAN-GANZ D200F7Edwards Lifesciences LLC · ELECTRODE, PACEMAKER, TEMPORARY1 recall0 reports
- ETHICON TPW32Ethicon, LLC · ELECTRODE, PACEMAKER, TEMPORARY1 death46 reports
- 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
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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