WECK IPN915186Recalls & reported problems
Teleflex Incorporated · HEMOLOK XL 6 Clips/Cart · Class 2 · Implant
Quick summary
This Teleflex Hem-o-lok clip cartridge is used to hold off tissue during surgery. Most of the 27 reports describe clips that broke or fractured while being applied, or were hard to open or close, sometimes on the appendix stump; a few mention bleeding and one report describes an injury. There were no deaths. No recalls name this device, and no reports were filed in the past 12 months.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 24026704695953), received between Sep 20, 2021 and Nov 17, 2022 — classified as 1 injury, 26 malfunctions.
The most frequently reported specific device problem is “Break” (18 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
- Break18
- Difficult to Open or Close4
- Detachment of Device or Device Component2
- Difficult or Delayed Separation1
- Fracture1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Hemorrhage/Blood Loss/Bleeding2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2022Break; Break
IT WAS REPORTED THAT ON ((B)(6)2020 CLIP WAS FOUND BROKEN DURING USE ON THE PATIENT. CLAMPED ON THE APPENDICULAR STUMP. ANOTHER CLIP WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15814326 ↗MalfunctionNov 4, 2022Break; Break
IT WAS REPORTED THAT ON 27 OCT 2020, A CLIP WAS FOUND BROKEN DURING USE ON THE PATIENT. CLAMPED ON THE APPENDICULAR STUMP. ANOTHER CLIP WAS USED. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15727769 ↗MalfunctionNov 1, 2022Break; Break
IT WAS REPORTED THAT (B)(6) 2022, CLIP WAS FOUND BROKEN DURING USING ON THE PATIENT. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15708937 ↗MalfunctionOct 31, 2022Break; Break
IT WAS REPORTED THAT ON (B)(4) 2022, 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 15699283 ↗MalfunctionOct 29, 2022Break; Break
IT WAS REPORTED THAT ((B)(6)2020, CLIP WAS FOUND BROKEN DURING USE ON THE PATIENT. THE APPENDICULAR STUMP WAS CLAMPED THEN USED ANOTHER CLIP. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15694941 ↗MalfunctionOct 29, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6)2022, A CLIP WAS FOUND BROKEN DURING USE ON THE PATIENT. THE APPENDICULAR STUMP WAS CLAMPED THEN ANOTHER CLIP WAS USED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15694685 ↗MalfunctionSep 30, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020, CLIP WAS FOUND BROKEN DURING USE ON THE PATIENT. NO CLIP FELL INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15513069 ↗MalfunctionSep 6, 2022Break; Break
(B)(6)2022 , CLIP WAS FOUND BROKEN DURING USING ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15363124 ↗MalfunctionAug 18, 2022Break; Break
ON (B)(6)2022, CLIP WAS FOUND BROKEN DURING USING ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15249710 ↗MalfunctionJul 25, 2022Break; Break
CLIP WAS FOUND BROKEN DURING USING ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15099666 ↗MalfunctionJul 19, 2022Difficult to Open or Close; Difficult to Open or Close
CLIP WAS FOUND NOT CLOSING DURING USING ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15056170 ↗MalfunctionJul 19, 2022Difficult to Open or Close; Difficult to Open or Close
CLIP WAS FOUND NOT CLOSING DURING USING ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15055915 ↗MalfunctionJun 9, 2022Break; Break
8 MAY 2021, CLIP WAS FOUND BROKEN DURING USING ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14644854 ↗MalfunctionMay 11, 2022Difficult to Open or Close; Difficult to Open or Close
ON (B)(6) 2022,THE CLIP DOES NOT CLOSE WHEN THE ILEOCOLIC ARTERY IS LIGATED WITH THE CLIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14353706 ↗MalfunctionMay 10, 2022Difficult or Delayed Separation; Difficult or Delayed Separation
THE INCIDENT HAPPENED ON (B)(6) 2022 IN THE OPERATING ROOM. DURING A NEPHRECTOMY, AFTER APPLYING THE CLIP ON A VESSEL, THE SURGEON WAS UNABLE TO SEPARATE THE APPLIER FROM THE CLIP. SEVERAL MANIPULATIONS ON THE APPLIER WERE NECESSARY TO SEPARATE THE APPLIER FROM THE CLIP. THE DEVICE WAS DISCARDED BY THE USER AND IS THEREFORE NOT AVAILABLE FOR EXPERTISE.
Patient problems: Insufficient Information
MAUDE report 14347720 ↗MalfunctionMay 3, 2022Break; Break
(B)(6) 2021, CLIP WAS FOUND BROKEN DURING USING ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14269171 ↗MalfunctionApr 26, 2022Break; Break
WHEN THE USER LIGATED A CLIP DURING A ROBOT-ASSISTED LAPAROSCOPIC NEPHRECTOMY, IT GOT BROKEN AT THE HOOK. THE BROKEN HOOK FELL IN THE PATIENT, BUT WAS REMOVED BY SUCTION. THE USER OPENED ANOTHER CARTRIDGE TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14211718 ↗InjuryApr 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE PATIENT DEVELOPED ABDOMINAL BLEEDING POST-OP AND HE WAS TAKEN BACK TO THEATRE WHERE A SCAN CONFIRMED THAT THE HEMOLOK CLIP WAS OPEN AND WAS LAYING IN THE PATIENT'S ABDOMEN. THERE WAS ABDOMINAL BLEEDING. CLINICAL CONSEQUENCES:THE DOCTOR REMOVED THE CLIP, THE PATIENT WAS VENTILATED AND TAKEN TO ICU.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14115838 ↗MalfunctionJan 25, 2022Break; Break
(B)(6) 2021, CLIP WAS FOUND BROKEN DURING USING ON THE PATIENT. THE SEVERED PART HAS BEEN REMOVED FROM THE PATIENT WITH NO ADVERSE FEEDBACK. INVOLVED 1 CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13342287 ↗MalfunctionJan 4, 2022Break; Break
ON (B)(6) 2021, CLIP WAS FOUND BROKEN DURING USING ON THE PATIENT. THE SEVERED PART HAS BEEN REMOVED FROM THE PATIENT WITH NO ADVERSE FEEDBACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13154059 ↗MalfunctionDec 23, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
AT THE (B)(6) UROLOGICAL ASSOCIATION, A DOCTOR PRESENTED ONE CASE BELOW THAT OCCURRED ABOUT 20 YEARS AGO. A CLIP FELL FROM THE RENAL ARTERY AFTER LAPAROSCOPIC TOTAL NEPHROURETERECTOMY AND IT CAUSED SERIOUS BLEEDING. AS A RESULT, HE THE DOCTOR SUTURED THE ARTERY TO STOP BLEEDING. THE DOCTOR REPORTED THIS FOR NOT COMPLAINING BUT FOR WARNING. THE DOCTOR THINKS IMPROPER USAGE CAUSED THIS ISSUE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 13079094 ↗MalfunctionDec 13, 2021Fracture; Fracture
ON (B)(6) 2021, CLIP WAS FOUND BROKEN DURING USING ON THE PATIENT. THE SEVERED PART HAS BEEN REMOVED FROM THE PATIENT WITH NO ADVERSE FEEDBACK. 1 CARTRIDGE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12983630 ↗MalfunctionDec 9, 2021Difficult to Open or Close; Difficult to Open or Close
(B)(6) 2021, THE PATIENT WAS TREATED WITH THE PRODUCT IN THE SURGICAL ENDOSCOPE AND IT WAS FOUND THAT THE CLAMPING WAS NOT TIGHT AND BLOOD VESSEL WAS OOZING. IMMEDIATELY AFTER THE DISCOVERY A SECOND CLIP WAS USED TO THE PROXIMAL END OF THE PRODUCT AND LIGATION WAS PERFORMED AGAIN TO ACHIEVE HEMOSTASIS EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12968047 ↗MalfunctionNov 17, 2021Break; Break
THE USER WAS UNABLE TO LIGATE A CLIP PROPERLY DURING AN UROLOGICAL SURGERY. ON CHECKING THE CLIP WAS FOUND BROKEN. ALTHOUGH THE CLIP FELL IN THE CAVITY IT WAS WITHDRAWN. THE USER OPENED A NEW CARTRIDGE TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12827949 ↗MalfunctionOct 4, 2021Break; Break
ON (B)(6) 2021,THE PATIENT WENT TO THE HOSPITAL BECAUSE OF ACUTE APPENDICITIS. DURING THE OPERATION THE CLIP WAS BROKEN AND REPLACED IMMEDIATELY WITHOUT CAUSING HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12569426 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.