TenderTrode Plus™ A10055-SRTRecalls & reported problems
Graphic Controls Acquisition Corp · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10813150021651), received between Jul 11, 2025 and Jul 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Disconnection1
- Material Separation1
- Peeled/Delaminated1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2025Disconnection; Peeled/Delaminated; Material Separation; Therapeutic or Diagnostic Output Failure
MULTIPLE EVENTS HAVE OCCURRED: TELEMETRY LEADS NOT FUNCTIONING, UPON OBSERVATION IT WAS NOTED THAT ONE OF THE LEADS (BLACK) BECAME DISCONNECTED FROM STICKER. ALSO WAS NOTED THAT THE OTHER 2 LEADS (WHITE AND GREEN) HAD SOME SEPARATION/PEELING ON STICKERS AND LOOSENING OF WIRES BUT NOT YET COMPLETELY DISCONNECTED. LEADS WERE REMOVED AND PROVIDED TO THE CLINICAL NURSE SPECIALIST IN SEVERAL INCIDENTS. [DATE REDACTED] TELEMETRY LEADS NOT FUNCTIONING, UPON OBSERVATION IT WAS NOTED THAT ONE OF THE LEADS (BLACK) BECAME DISCONNECTED FROM STICKER. ALSO WAS NOTED THAT THE OTHER 2 LEADS (WHITE AND GREEN) HAD SOME SEPARATION/PEELING ON STICKERS AND LOOSENING OF WIRES BUT NOT YET COMPLETELY DISCONNECTED. LEADS WERE REMOVED FROM PATIENT AND BAGGED, GIVEN TO CNS [CLINICAL NURSE SPECIALIST]. [DATE REDACTED] THE WIRE CAME SEPARATED FROM LEAD LOT #102624 [DATE REDACTED] THE WIRE SEPARATED FROM THE LEAD. LOT NUMBER #102624 [DATE REDACTED] WHITE LEAD OF EKG [ELECTROCARDIOGRAM] LEADS, WIRE DISCONNECTED FROM UNDER STICKER, SO CENTRAL MONITOR WAS ALARMING. BABY'S FEED AT BREAST HAD TO BE PAUSED TO PUT ON A NEW STICKER. [DATE REDACTED] ECG [ELECTROCARDIOGRAM] WIRE CAME APART FROM THE GEL ADHERENCE PAD. [DA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478411 ↗
Other Electrode, Electrocardiograph devices
- Vermed A10091-30Graphic Controls Acquisition Corp · Electrode, Electrocardiograph132 reports
- 3M™ 22283m Company · Electrode, electrocardiograph2 recalls0 reports
- 3M™ Red Dot™ 22283m Company · Electrode, electrocardiograph1 recall4 reports
- Vital Signs™ 2464AAO-20AirLife Finland Oy · Electrode, electrocardiograph51 reports
- Vermed IP-Set M5 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set 12 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set N3-Pediatric-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set M3 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.