Lapro-Clip 8886848813Recalls & reported problems
Covidien LP · Absorbable Ligating Clip Cartridge · Class 2 · Implant
All models of Lapro-Clip (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Lapro-Clip absorbable clip is used in keyhole surgery to tie off vessels and ducts. Of its 564 reports, 506 describe malfunctions, most often mechanical problems, breaks and clips slipping, and 58 describe injuries. Patients mention bleeding in 47 reports. Recent reports describe clips breaking during gallbladder removal or failing to clamp, with surgeons replacing them. No deaths are recorded, and no recalls name 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
- 565
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 565 adverse event reports that list this exact device (DI 10884521057661), received between Aug 22, 2017 and Sep 21, 2026 — classified as 58 injuries, 507 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (226 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem226
- Break131
- Device Slipped99
- Detachment of Device or Device Component95
- Failure to Fire50
- Mechanics Altered38
- Adverse Event Without Identified Device or Use Problem28
- Entrapment of Device18
Patient problems
- No Clinical Signs, Symptoms or Conditions301
- No Consequences Or Impact To Patient89
- Insufficient Information83
- Hemorrhage/Blood Loss/Bleeding48
- No Known Impact Or Consequence To Patient48
- Unspecified Tissue Injury31
- No Code Available14
- Abdominal Pain9
Recent adverse event reports
The 25 most recent of 565 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Failure to Fire; Adverse Event Without Identified Device or Use Problem
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 50841076 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828054 ↗MalfunctionAug 14, 2026Mechanics Altered
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260828 ↗MalfunctionMay 22, 2026Mechanical Problem; Device Slipped
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AFTER DISSECTION OF CALOT¿S TRIANGLE AND A CLIP WAS APPLIED TO LIGATE THE CYSTIC DUCT, POOR CLOSURE OF THE CLIP WAS IDENTIFIED, AND THE CLIP BECAME DISLODGED. THE DISLODGED CLIP WAS IMMEDIATELY REMOVED AND REPLACED WITH ANOTHER CLIP. ADJUSTMENT OF THE LIGATION STRATEGY WAS REQUIRED, THEREBY EXTENDING ANESTHESIA AND SURGERY DURATION.
Patient problems: Insufficient Information
MAUDE report 25262989 ↗MalfunctionMay 1, 2026Device Slipped
IT WAS REPORTED THAT DURING A PROCEDURE, ON TWO RELOADS, THE OPERATOR FIRED THE CLIP NORMALLY FROM THE APPLIER BUT THE CLIP DID NOT CLAMP THE VESSEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25060164 ↗MalfunctionMay 1, 2026Device Slipped
IT WAS REPORTED THAT DURING A PROCEDURE, ON TWO RELOADS, THE OPERATOR FIRED THE CLIP NORMALLY FROM THE APPLIER BUT THE CLIP DID NOT CLAMP THE VESSEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25060112 ↗MalfunctionApr 7, 2026Break
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN AN ABSORBABLE CLIP WAS USED TO CLOSE THE CYSTIC DUCT, THE CLIP FRACTURED. THE DOCTOR THEN CLAMPED THE CYSTIC DUCT WITH FORCEPS AND REAPPLIED AN ABSORBABLE CLIP TO SUCCESSFULLY CLOSE THE CYSTIC DUCT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24797405 ↗MalfunctionApr 2, 2026Break
ACCORDING TO THE REPORTER, DURING APPENDECTOMY PROCEDURE, THE CLIP FRACTURED IMMEDIATELY WITH A LIGHT CLAMP AND COULD NOT BE USED. A NEW DEVICE WAS USE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24772326 ↗MalfunctionMar 30, 2026Mechanical Problem; Device Slipped
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE OPERATOR NEEDED TO LIGATE TISSUE OR VESSELS FOR HEMOSTASIS. WHEN USING AN ABSORBABLE LIGATURE CLIP, ISSUES SUCH AS INCOMPLETE CLOSURE OR POOR HOLDING STRENGTH OCCURRED, MAKING THE CLIP UNUSABLE. TO RESOLVE THE ISSUE, REAPPLIED THE CLIP, PERFORMED SUTURING, AND REINFORCED HEMOSTASIS AS NEEDED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24722373 ↗MalfunctionMar 2, 2026Mechanics Altered
IT WAS REPORTED THAT DURING GASTROINTESTINAL TUMOR RESECTION, PRIOR TO PATIENT USE, THE HANDLE SQUEEZED BUT THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24480107 ↗MalfunctionFeb 24, 2026Failure to Fire; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, DURING VESSEL LIGATION, THE BLACK CARTRIDGE, INCLUDING THE CLIP, REMAINED ATTACHED TO THE VESSEL AND DETACHED FROM THE APPLICATOR. THE COMPONENT DISENGAGED FROM THE CAVITY BUT WAS ABLE TO BE RETRIEVED. THE CARTRIDGE WAS REMOVED, AND THE PROCEDURE WAS REPEATED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430603 ↗MalfunctionFeb 11, 2026Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE ABSORBABLE LIGATURE CLIP BROKE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314736 ↗MalfunctionJan 9, 2026Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANESTHESIA, WHEN DIVIDING THE CYSTIC ARTERY, THE CLIP BROKE, BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. A NEW LIGATION CLIP WAS USED TO LIGATE THE CYSTIC ARTERY AGAIN. THE SURGICAL TREATMENT WAS DELAYED BUT NOT MORE THAN 30 MINUTES. POSTOPERATIVELY, PATIENT CARE WAS STRENGTHENED.
Patient problems: Insufficient Information
MAUDE report 24023333 ↗MalfunctionJan 9, 2026Mechanical Problem
IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY, THE TIP OF THE ABSORBABLE LIGATION CLIP COULD NOT CLOSE PROPERLY AND COULD NOT BE USED AS INTENDED, CAUSING A DELAY IN THE SURGICAL PROCEDURE. A BACKUP HEMOSTATIC CLIP WAS IMMEDIATELY USED INSTEAD.
Patient problems: Insufficient Information
MAUDE report 24017295 ↗MalfunctionDec 29, 2025Mechanical Problem; Device Difficult to Setup or Prepare; Mechanical Problem; Device Difficult to Setup or Prepare
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GALLBLADDER SURGERY ON THE CYSTIC ARTERY, THE CLIP WAS NOT FORMED CORRECTLY AND THE DEVICE WAS DIFFICULT TO DISASSEMBLE. ANOTHER CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23913820 ↗MalfunctionDec 22, 2025Break; Break
ACCORDING TO THE REPORTER, DURING THE APPENDECTOMY, ABSORBABLE LIGATURE CLIP WAS INTENDED TO BE USED TO CLAMP THE VESSELS. AFTER THE FIRST LIGATURE CLIP WAS CLAMPED WITH THE APPLICATOR, IT BROKE. ANOTHER LIGATURE CLIP WAS THEN REPLACED TO CONTINUE THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 23873940 ↗MalfunctionDec 18, 2025Device Slipped; Device Slipped
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANESTHESIA, THE GALLBLADDER ARTERY BEGAN BLEEDING. AFTER ABDOMINAL GAUZE WAS SOAKED WITH BLOOD, AN ABSORBABLE LIGATION CLIP WAS USED TO CLAMP THE ARTERY IN AN ATTEMPT TO STOP THE BLEEDING. HOWEVER, DURING THE CLAMPING PROCESS, THE LIGATION CLIP WAS FOUND TO BE UNSTABLE, AS BLEEDING CONTINUED AND THE CLIP FELT LOOSE TO THE TOUCH. THE CLIP WAS THEN REPLACED WITH A TISSUE CLOSURE CLAMP TO CONTROL THE BLEEDING. A NEW LIGATURE CLIP WAS IMMEDIATELY USED INSTEAD.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23846729 ↗InjuryDec 9, 2025Device Slipped; Device Slipped
ACCORDING TO THE REPORTER, DURING THE CHOLECYSTECTOMY DUE TO GALLSTONES WITH CHOLECYSTITIS, THE ABSORBABLE LIGATURE CLIP BECAME LOOSE AND DETACHED WHICH LED TO MASSIVE HEMORRHAGIC SHOCK. CENTRAL VENOUS CATHETERIZATION WAS PERFORMED. THE MEDICAL STAFF CARRIED OUT UNPLANNED REOPERATION FOR HEMOSTASIS, PERFORMED EMERGENCY BLOOD MATCHING, TRANSFUSED 4 UNITS OF SUSPENDED RED BLOOD CELLS, AND RAPIDLY INFUSED LARGE AMOUNTS OF FLUIDS TO MAINTAIN BLOOD PRESSURE.
Patient problems: Shock
MAUDE report 23761028 ↗MalfunctionNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, ABSORBABLE LIGATURE CLIP WAS USED TO CLAMP THE RIGHT GASTROEPIPLOIC ARTERY WHEN IT WAS TRANSECTED. HOWEVER, AFTER TRANSECTION, THE VESSEL STUMP CONTINUED TO BLEED PROFUSELY. THE SURGEON IMMEDIATELY PERFORMED SUTURELIGATURE TO ACHIEVE HEMOSTASIS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23669603 ↗MalfunctionNov 18, 2025Break; Break
ACCORDING TO THE REPORTER, DURING AN ACUTE APPENDICITIS SURGERY, THE CLIP BROKE. THE SURGERY WAS COMPLETED AFTER REPLACING IT WITH A NEW PRODUCT.
Patient problems: Insufficient Information
MAUDE report 23579704 ↗MalfunctionNov 17, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE CLIP WAS FOUND TO BE BROKEN AFTER THE CLIP WAS APPLIED. THE BROKEN CLIP WAS QUICKLY REMOVED, AND A NEW CLIP WAS USED. IT WAS NOTED THAT THE SURGICAL TIME WAS PROLONGED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23565990 ↗MalfunctionNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A PARTIAL HEPATECTOMY DUE TO INTRAHEPATIC BILE DUCT STONES, WHILE BEING USED TO CLAMP THE INTRAHEPATIC BLOOD VESSELS AND AFTER TRANSECTION, THE VESSEL STUMPS CONTINUED TO BLEED PROFUSELY. THE SURGEON IMMEDIATELY PERFORMED SUTURE LIGATURE TO ACHIEVE HEMOSTASIS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23487606 ↗MalfunctionNov 6, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY DUE TO GALLBLADDER AND CHOLECYSTITIS, IT WAS FOUND THAT THE CLIP WAS DAMAGED WHILE LIGATING THE CYSTIC DUCT. THE DAMAGED CLIP WAS REMOVED AND REPLACED WITH A NEW ONE.
Patient problems: Insufficient Information
MAUDE report 23487020 ↗MalfunctionNov 5, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN APPLYING IT WITH THE BIOPSY FORCEPS, THE LIGATURE CLIP BROKE. THE LIGATURE CLIP WAS REPLACED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 23477576 ↗MalfunctionNov 4, 2025Device Slipped; Device Slipped
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, DURING VASCULAR CLIPPING, THE CLIP FAILED TO CLOSE PROPERLY AND SLIPPED OFF. A NEW ABSORBABLE LIGATURE CLIP WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23468998 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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