TETHERTAPE IPN056933Recalls & reported problems
Teleflex Incorporated · UHMWPE size 1.5MM Blue braid No needles 38" ICONN · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00860419000233), received between Apr 3, 2023 and Apr 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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.
Most reported problems
Device problems
- Material Separation1
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.
MalfunctionApr 3, 2023Material Separation; Material Separation
REPORTED ISSUE: DURING A SURGICAL PROCEDURE, WHEN USING THE PRODUCT ON THE MUSCLE, IT BROKE. THERE WAS ANOTHER PRODUCT FROM THE SAME BATCH, IT WORKED WELL AND THE PROCEDURE WAS PERFORMED WITHOUT ANY OTHER INCONVENIENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16668174 ↗
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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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