WECK IPN915184Recalls & reported problems
Teleflex Incorporated · HEMOLOK L 6 Clips/Cart · Class 2 · Implant
Quick summary
This Teleflex Hem-o-lok surgical clip is a small implantable clip used to close blood vessels during surgery. The 52 reports mostly describe clips breaking during use, or failing to open or close properly, so a second clip had to be used; none report a death or an injury, and reports state no clip fragments were left in the patient. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 24026704695939), received between Aug 12, 2021 and Apr 26, 2023 — classified as 52 malfunctions.
The most frequently reported specific device problem is “Break” (25 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
- Break25
- Difficult to Open or Close15
- Difficult or Delayed Activation2
- Improper or Incorrect Procedure or Method2
- Positioning Failure2
- Activation, Positioning or Separation Problem1
- Detachment of Device or Device Component1
- Device Damaged Prior to Receipt by User1
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2023Break; Break
IT WAS REPORTED THAT THE "CLIP WAS FOUND BROKEN DURING USAGE ON THE PATIENT". ADDITIONAL INFORMATION STATES THAT NO PART OR CLIP FELL/WAS RETAINED INSIDE THE PATIENT'S BODY. NO MEDICAL INTERVENTION NEEDED. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16817248 ↗MalfunctionApr 26, 2023Break; Break
IT WAS REPORTED THAT THE "CLIP WAS FOUND BROKEN DURING USAGE ON THE PATIENT". ADDITIONAL INFORMATION STATES THAT NO PART OR CLIP FELL/WAS RETAINED INSIDE THE PATIENT'S BODY. NO MEDICAL INTERVENTION NEEDED. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16817219 ↗MalfunctionApr 20, 2023Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CLIP DOES NOT CLOSE. THE ISSUE WAS RESOLVED BY USING ANOTHER CLIP. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 16775728 ↗MalfunctionMar 29, 2023Break; Break
REPORTED ISSUE: THE CLIP WAS FOUND BROKEN DURING USAGE; ANOTHER CLIP WAS USED. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16639442 ↗MalfunctionMar 29, 2023Break; Break
REPORTED ISSUE: A LARGE WECK HEM-O-LOC CLIP WAS BEING PLACED ON A VESSEL WITH ROBOT WHEN THE CLIP BROKE IN HALF AT THE HINGE SIDE OF THE CLIP. THE BROKEN CLIP WAS REMOVED FROM THE PATIENT AND A NEW CLIP WAS USED WITHOUT FURTHER INCIDENT. PATIENT WAS NOT INJURED NOR ADVERSE IMPACT OCCURRING AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16639178 ↗MalfunctionMar 18, 2023Difficult to Open or Close; Difficult to Open or Close
REPORTED ISSUE: (B)(6)2023, THE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT. ANOTHER CLIP WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16569362 ↗MalfunctionMar 16, 2023Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE CLIP DOES NOT CLOSE PROPERLY. AS A RESULT, ANOTHER CLIP WAS USED FROM THE SAME BATCH. NO PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: Insufficient Information
MAUDE report 16553999 ↗MalfunctionMar 16, 2023Break; Break
IT WAS REPORTED THAT A CLIP WAS FOUND BROKEN BEFORE USE. THEREFORE, ANOTHER CLIP WAS USED. NO PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: Insufficient Information
MAUDE report 16553996 ↗MalfunctionFeb 27, 2023Difficult to Open or Close; Difficult to Open or Close
REPORTED ISSUE: THE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT. ANOTHER CLIP WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16448809 ↗MalfunctionFeb 8, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
REPORTED EVENT: THE DEVICE WOULD NOT LOCK WHILE OPERATING. THE TECHS THEN TRIED DIFFERENT (B)(4) CARTRIDGES FROM THE SAME LOT ' ON THE BACK TABLE AND WOULD NOT LOCK. THE ISSUE WAS RESOLVED BY OPENING A NEW BOX WITH A DIFFERENT LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16324376 ↗MalfunctionJan 30, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
REPORTED EVENT: THE DEVICE WOULD NOT LOCK WHILE OPERATING. THE TECHS THEN TRIED DIFFERENT 544240 CARTRIDGES FROM THE SAME LOT ON THE BACK TABLE AND WOULD NOT LOCK. RESOLVED PROBLEM BY OPENING A NEW BOX WITH DIFFERENT LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16268619 ↗MalfunctionJan 30, 2023Entrapment of Device; Entrapment of Device
REPORTED EVENT: WHILE ATTEMPTING TO APPLY CLIPS ON A VESSEL, THE APPLIER DID NOT RELEASE THE CLIP. THREE APPLIERS WERE USED WITH THE SAME RESULTS. WE TRIED WITH SEVERAL CARTRIDGES FROM THE SAME LOT NUMBER 73E2100914, AND THE CLIPS WOULD NOT RELEASE. WE CHANGED THE LOT NUMBER OF THE CARTRIDGE AND IT ALL WORKED PROPERLY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16264769 ↗MalfunctionJan 29, 2023Break; Break
REPORTED EVENT: (B)(6)2022 , A CLIP WAS FOUND BROKEN DURING CLAMPING OF LIVER VESSELS. ANOTHER CLIP WAS USED OF A DIFFERENT UNKNOWN SIZE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261706 ↗MalfunctionJan 24, 2023Difficult to Open or Close; Difficult to Open or Close
REPORTED EVENT: NOV 2022, A LAPAROSCOPIC APPENDECTOMY WAS PERFORMED. THE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT; ANOTHER CLIP WAS USED. 1 PC INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16233780 ↗MalfunctionDec 22, 2022Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT ON (B)(6)2022 THE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT. ONE PIECE WAS INVOLVED AND ANOTHER ONE WAS USED. THERE WAS NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16038127 ↗MalfunctionDec 20, 2022Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT ON (B)(6)2022., ONE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT AND ANOTHER CLIP WAS USED FROM AN UNKNOWN BATCH. REQUESTED ADDITIONAL INFORMATION IS REPORTEDLY NOT AVAILABLE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16014232 ↗MalfunctionDec 15, 2022Unsealed Device Packaging; Unsealed Device Packaging
REPORTED ISSUE: THE CLIPS ARE POORLY PACKED AND OPEN. FOUND PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15987939 ↗MalfunctionDec 14, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6)2022, A CLIP WAS FOUND BROKEN DURING CLAMPING OF THE BILE DUCT. ONE PIECE WAS INVOLVED AND ANOTHER CLIP WAS USED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15983064 ↗MalfunctionDec 14, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6)2020 , A CLIP WAS FOUND BROKEN BROKEN PRIOR TO USE. MORE INFORMATION IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15976556 ↗MalfunctionDec 9, 2022Break; Break
IT WAS REPORTED THAT ON(B)(6)2022, CLIP WAS FOUND BROKEN DURING CLAMPING COMMON BILE DUCT. IT INVOLVED 1 PIECE. ANOTHER CLIP FROM AN UNKNOWN BATCH WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15951181 ↗MalfunctionDec 5, 2022Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT ON (B)(6)2022, THE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT. ONE PIECE WAS INVOLVED. ANOTHER CLIP WAS USED. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15920444 ↗MalfunctionDec 5, 2022Break; Break
IT WAS REPORTED THAT ON ((B)(6)2020, A CLIP WAS FOUND BROKEN DURING LATERAL PROSTATIC LIGAMENT LIGATION. IT INVOLVED ONE PIECE. ANOTHER CLIP WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15915908 ↗MalfunctionDec 5, 2022Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT ON (B)(6)2022, THE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT; ANOTHER CLIP WAS USED. ONE PIECE WAS INVOLVED. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15915575 ↗MalfunctionNov 17, 2022Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT ON (B)(6) 2020 THE CLIP DOES NOT CLOSE DURING USAGE ON THE PATIENT. ANOTHER CLIP WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15814988 ↗MalfunctionNov 10, 2022Break; Break
IT WAS REPORTED THAT ON ((B)(6)2020 A CLIP WAS FOUND BROKEN DURING USE ON THE PATIENT. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15771933 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.