WECK IPN920981Recalls & reported problems
Teleflex Incorporated · HORIZON TI ML 6 Clips/Cart · Class 2 · Implant
Data updated Oct 13, 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 14026704725325), received between Mar 26, 2026 and Mar 26, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Jam” (1 report).
1 other recall cover devices cleared under the same FDA submission (K982313); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Mechanical Jam
IT WAS REPORTED THAT "WHEN THE SURGEON CLIPS A VESSEL (CLOSES THE APPLIER), THE CLIP REMAINS STUCK TO THE APPLIER AND TEARS THE VESSEL WHEN THEY TRY TO REMOVE THE APPLIER. PATIENT ADMITTED FOR MAJOR SURGERY (HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY - HIPEC) DURING WHICH SIGNIFICANT BLOOD LOSS OCCURRED. THE MEDICAL REPORT STATES THAT THE DEVICE IS NOT SPECIFICALLY INVOLVED. BLOOD LOSS IS ESTIMATED AT 1.15 L WITH A URINE OUTPUT OF 1.8 L. THE PATIENT RECEIVED 12 L OF FLUID RESUSCITATION, INCLUDING 9.5 L OF NACL AND 2.5 L OF ISOFUNDIN, AS WELL AS 4 DOSES OF 20% ALBUMIN. THE PATIENT RECEIVED A TRANSFUSION OF 2 UNITS OF PACKED RED BLOOD CELLS DURING THE OPERATION. PATIENT ADMITTED TO THE ICU POST-OPERATIVELY WITH CLOSE MONITORING."
Patient problems: Vascular Dissection
MAUDE report 24705538 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K982313. One submission often covers many models, so check the product and lot details in each record.
- Z-2327-2016 · Aug 8, 2013 · TerminatedHorizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic stru
Other Clip, implantable devices
- LIGAMAX EL5MLEthicon Endo-Surgery, LLC · CLIP, IMPLANTABLE3 deaths3,808 reports
- Endo Clip III 176630Covidien LP · CLIP, IMPLANTABLE1 death1,959 reports
- Epix® Universal Clip Applier CA500Applied Medical Resources Corporation · Clip, Implantable1 recall1 death1,183 reports
- Endo Clip II 176657Covidien LP · CLIP, IMPLANTABLE1,183 reports
- LIGACLIP ER320Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE1,115 reports
- Direct Drive® Clip Applier CA090Applied Medical Resources Corporation · Clip, Implantable1 death806 reports
- LAPRA-TY XC200Ethicon Inc. · CLIP, IMPLANTABLE791 reports
- Endo Clip 176625Covidien LP · CLIP, IMPLANTABLE1 death768 reports
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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