BTP-1000L-2 02-00139Recalls & reported problems
Braemar Manufacturing, LLC · 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 B146BTPL20), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Biocompatibility1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Pain1
- Rash1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2024Biocompatibility; Biocompatibility
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS EXPERIENCING A RASH WHILE WEARLING THE LEAD WIRE ADAPATER (LWA). THE PATIENT NOTED THAT THE THE RASH HAD SPREAD TO THE NIPPLE/BREAST AREA AND BRUISING WAS PRESENT. THEY WERE EXPERIENCING BLEEDING, SCRAPPINESS, OOZING AND RAWNESS THAT IS VERY PAINFUL. THE PATIENT CONTACTED THEIR DERMATOLOGIST REGARDING THE RASH AND THEY WERE PRESCRIBED DOXYCYCLINE TO TAKE TO RELIEVE IRRITATION. THE PATIENT'S CARDIOLOGIST ADVISED THE PATIENT TO CONTINUE MONITORING. THE PATIENT REPORTED THAT THEY HAVE NUMEROUS ALLERGIES TO TRIPLE OINTMENT INGREDIENTS AND LATEX AND A MILD ADHESIVE ALLERGY. IT IS THOUGHT THE SKIN IRRITATION IS DUE TO THE ELECTRODES.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Rash; Skin Inflammation/ Irritation
MAUDE report 18935598 ↗
Other Cable, Electrode devices
- N/A ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall1 report
- N/A ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG TRUNK CABLE, 12-LEAD, AHA, 1.2 M/4 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page