ReliaTack RELTACK5RSWRecalls & reported problems
Covidien LP · Violet Standard Purchase Absorable Tacks · Class 2
All models of ReliaTack (10)
Data updated Oct 18, 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 10884521726345), received between Jun 1, 2020 and Jun 1, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 18, 2026.
Most reported problems
Device problems
- Device Difficult to Setup or Prepare1
- Positioning Failure1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2020Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UMBILICAL HERNIA, WHEN TACKING, THERE WERE DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE, THE RELOAD WAS SECURELY FASTENED ONTO THE SHAFT, THE TACKS WOULD NOT DEPLOY FROM THE RELOAD. ANOTHER RELOAD WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10105182 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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