TheraSleeve® with I-Seed XX992xiRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813787020433), received between Oct 17, 2024 and Oct 17, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Device Markings/Labelling Problem; Wrong Label; Device Markings/Labelling Problem; Wrong Label

  THE NON-STERILIZED SEEDS AND PAPERWORK INCLUDED IN THE ORDERS WERE LABELED CORRECTLY, BUT THE PRE-STERILIZED NEEDLE TRAYS WERE ALL LABELED INCORRECTLY. THE LABELING OF THE PRE-STERILIZED NEEDLE TRAYS FOR ORDERS (B)(6) WERE INADVERTENTLY SWITCHED WHEN THE LABELING FOR THE NEEDLE TRAYS WERE APPLIED. THERE WERE TWO (2) PRE-STERILIZED NEEDLE TRAYS PER ORDER THAT WERE LABELED INCORRECTLY. SEE ORDERS BELOW: ORDER (B)(6) PATIENT (B)(6). COMPLAINANT SUBMITTED VARISEED NEEDLE LOADING REPORT/PLAN: AGX100 I-125. 0.237 MCI PER SEED. (B)(4) SEEDS, (B)(4) PRE-LOADED NEEDLES. TOTAL ACTIVITY PER PLAN: 20.856 MCI. ORDER (B)(6) PATIENT (B)(6). COMPLAINANT SUBMITTED VARISEED NEEDLE LOADING REPORT/PLAN: AGX100 I-125. 0.357 MCI PER SEED. (B)(4) SEEDS, (B)(4) PRE-LOADED NEEDLES. TOTAL ACTIVITY PER PLAN: 27.846 MCI.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20470426 ↗
• InjuryOct 17, 2024Device Markings/Labelling Problem; Wrong Label; Device Markings/Labelling Problem; Wrong Label

  THE NON-STERILIZED SEEDS AND PAPERWORK INCLUDED IN THE ORDERS WERE LABELED CORRECTLY, BUT THE PRE-STERILIZED NEEDLE TRAYS WERE ALL LABELED INCORRECTLY. THE LABELING OF THE PRE-STERILIZED NEEDLE TRAYS FOR ORDERS (B)(6) WERE INADVERTENTLY SWITCHED WHEN THE LABELING FOR THE NEEDLE TRAYS WERE APPLIED. THERE WERE TWO (2) PRE-STERILIZED NEEDLE TRAYS PER ORDER THAT WERE LABELED INCORRECTLY. SEE ORDERS BELOW: ORDER (B)(6) PATIENT (B)(6). COMPLAINANT SUBMITTED VARISEED NEEDLE LOADING REPORT/PLAN: AGX100 I-125. 0.357 MCI PER SEED. 78 SEEDS, 28 PRE-LOADED NEEDLES. TOTAL ACTIVITY PER PLAN: 27.846 MCI . ORDER (B)(6) PATIENT (B)(6). COMPLAINANT SUBMITTED VARISEED NEEDLE LOADING REPORT/PLAN: AGX100 I-125. 0.237 MCI PER SEED. 88 SEEDS, 28 PRE-LOADED NEEDLES. TOTAL ACTIVITY PER PLAN: 20.856 MCI.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20470401 ↗