WECK IPN028180Recalls & reported problems
Teleflex Incorporated · HORIZON APPLIER SMALL WIDE 8" CURVED · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34026704622628), received between Jul 11, 2023 and Jul 11, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT "WHILE THE PA WAS USING THE RED CLIP APPLIERS TO CLIP ARTERY BRANCHES ON THE ENDOSCOPIC VEIN HARVESTING, THE CLIP APPLIER SEVERED AN ARTERY." FURTHER INFORMATION STATES THAT THIS EVENT OCCURRED DURING A CORONARY BYPASS SURGERY AND THE BRANCHES ON THE LEFT INTERNAL MAMMARY GLAND WERE BEING CLIPPED ON. THE DEFECT IS REPORTED AS "THE SCISSOR LIKE APPLICATION HAD MISALIGNED TIPS". THE ISSUE WAS RESOLVED BY REPAIRING THE MAMMARY ARTERY BY SUTURING AND USING A NEW APPLIER TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND ESTIMATED BLOOD LOSS WAS "MINIMAL". THERE WAS "NO FURTHER HARM, THIS PROLONGED THE CASE FOR 15 MINUTES TO ASSESS THE REPAIR (LIMA). THIS DID NOT EXTEND OR CHANGE THE AMOUNT OF BLOOD LOSS FOR THE PATIENT, WAS ABLE TO USE THE MAMMARY FOR CONDUIT. PATIENT WAS DISCHARGED".
Patient problems: Laceration(s)
MAUDE report 17297726 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.