ReliaTack RELTACK8RDPTSWRecalls & reported problems
Covidien LP · Articulating Reloadable Fixation Device · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521726352), received between Jul 26, 2018 and Sep 9, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Device Difficult to Setup or Prepare1
- Device Fell1
Patient problems
- Foreign Body In Patient2
- Constipation1
- No Code Available1
- Pain1
- Radiation Exposure, Unintended1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2019Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UMBILICAL HERNIA PROCEDURE, WHILE WORKING ON THE ABDOMEN, SURGEON EXPERIENCED DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE. IT WAS ALSO NOTED THAT THE RELOAD FELL INTO THE PATIENT'S CAVITY. SURGEON OPENED NEW DEVICE TO COMPLETE THE CASE.
Patient problems: Foreign Body In Patient
MAUDE report 8975037 ↗InjuryJul 26, 2018Detachment of Device or Device Component; Device Fell
ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE WAS IN THE ARTICULATED POSITION WHEN IT WAS REMOVED FROM THE TROCAR AND THE RELOAD FELL OFF AND WAS LEFT IN THE ABDOMEN WITHOUT NOTICE. THE PATIENT CAME BACK TO OPERATING ROOM A DAY AFTER LAPAROSCOPIC VENTRAL SURGERY WITH CONSTIPATION AND PAIN. THE SYMPTOMS DID NOT SUBSIDE SO PATIENT HAD AN X-RAY AND FOREIGN OBJECT WAS FOUND IN THE PATIENT. THE OBJECT WAS THE RELOAD. THE SURGEON COMPLETED A SECOND SURGERY TO REMOVE THE OBJECT. THE EVENT LED TO EXTENDED PATIENT HOSPITALIZATION FOR ONE DAY.
Patient problems: Constipation; Foreign Body In Patient; No Code Available; Pain; Radiation Exposure, Unintended
MAUDE report 7722929 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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