Premium SurgiClip III 133650Recalls & reported problems

Summary

The FDA's MAUDE database contains 508 adverse event reports that list this exact device (DI 10884521517394), received between Jan 10, 2017 and Sep 23, 2026 — classified as 29 injuries, 479 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (329 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 508 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Mechanical Problem

  It was reported that during an open femoral bypass, the clips did not deploy correctly when fired, several clips were released simultaneously when the handle was squeezed. The device was replaced with another clip applier to complete the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863759 ↗
• MalfunctionSep 21, 2026Mechanical Problem

  It was reported that, during a procedure, the clip did not form well. The surgeon was able to squeeze the handle. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843802 ↗
• MalfunctionAug 31, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50518797 ↗
• MalfunctionAug 14, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253225 ↗
• MalfunctionAug 13, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232148 ↗
• MalfunctionJul 15, 2026

  USED COVIDIEN SMALL CLIP APPLIER 9.0" TO FOR SIDE BRANCH VEIN CLIPPING CAME OUT WITH TWIST AND UNABLE TO RETRIEVE FROM VEIN, TORN VEIN SIDE BRANCH TWICE. VEIN WAS NOT IN PT AT THE TIME. VEIN STILL ABLE TO BE USED FOR CABG [CORONARY ARTERY BYPASS GRAFT]; NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25825817 ↗
• MalfunctionJun 5, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING AN OPEN MYOCARDIAL REVASCULARIZATION, WHILE ON PREPARATION OF THE SAPHENOUS VEIN FOR BYPASS SURGERY AND AT THE TIME OF VESSEL OCCLUSION, THE CLIPS DID NOT CLOSE COMPLETELY, AND FRAGMENTS DETACHED. ANOTHER DEVICE FROM A DIFFERENT BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414016 ↗
• MalfunctionMay 22, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN PYLORUS-RESECTING PANCREATODUODENECTOMY (PRPD), WHILE ON USE, THE CLIPS ARE NOT LOADING PROPERLY INTO THE JAWS. THE UNIT WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262844 ↗
• MalfunctionApr 16, 2026Mechanical Problem; Detachment of Device or Device Component; Mechanics Altered

  ACCORDING TO THE REPORTER, FOUR CLIP APPLIERS HAD ISSUES. WHEN THE CLIPS WERE CLOSED, THE CLIPS REOPENED NOT MAINTAINING CLOSURE. ADDITIONALLY, FOR TWO OF THE FOUR CLIP APPLIERS, THE HANDLES WERE SQUEEZED BUT THERE WERE ISSUES WITH FIRING OR LOADING THE CLIPS. THE FOURTH CLIP APPLIER ALSO HAD MALFORMED CLIPS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903715 ↗
• MalfunctionApr 16, 2026Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, FOUR CLIP APPLIERS HAD ISSUES. WHEN THE CLIPS WERE CLOSED, THE CLIPS REOPENED NOT MAINTAINING CLOSURE. ADDITIONALLY, FOR TWO OF THE FOUR CLIP APPLIERS, THE HANDLES WERE SQUEEZED BUT THERE WERE ISSUES WITH FIRING OR LOADING THE CLIPS. THE FOURTH CLIP APPLIER ALSO HAD MALFORMED CLIPS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903598 ↗
• MalfunctionApr 16, 2026Mechanical Problem; Detachment of Device or Device Component; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE CLIPS OF FOUR CLIP APPLIERS WERE CLOSED, THE CLIPS REOPENED NOT MAINTAINING CLOSURE. CLIPS FELL INTO THE PATIENT'S CAVITY AND WERE REMOVED WITH FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896173 ↗
• MalfunctionApr 16, 2026Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE CLIPS OF FOUR CLIP APPLIERS WERE CLOSED, THE CLIPS REOPENED NOT MAINTAINING CLOSURE. CLIPS FELL INTO THE PATIENT'S CAVITY AND WERE REMOVED WITH FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896109 ↗
• MalfunctionApr 7, 2026Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY BREAST RECONSTRUCTION, THE CLIPPING COULD NOT BE DONE CORRECTLY SEVERAL TIMES AND NOT LOADING PROPERLY INTO THE JAWS. A NEW CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799260 ↗
• MalfunctionApr 6, 2026Device Slipped; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN TRACHEOSTOMY, THE DEVICE WAS APPLIED TO A BLOOD VESSEL. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE APPLICATOR DID NOT RELEASE THE CLIP CORRECTLY ONTO THE VESSEL AND CAUSED VESSEL DAMAGE. THE CLIP DETACHED FROM THE VESSEL A FEW MINUTES AFTER APPLICATION. THERE WAS POST-SURGICAL HEMORRHAGE, DELAY IN SURGERY WITH SURGICAL TIME EXTENDED BY 30 MINUTES OR MORE. THE PATIENT WAS TREATED FOR POST-SURGICAL HEMORRHAGE BY REMOVAL OF THE CLIPS, REPLACEMENT WITH SINGLE-USE CLIPS, LIGATION WITH SUTURE, AND CAUTERIZATION OF THE VESSEL USING BIPOLAR ENERGY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24789892 ↗
• MalfunctionApr 6, 2026Device Slipped; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN TRACHEOSTOMY, THE DEVICE WAS APPLIED TO A BLOOD VESSEL. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE APPLICATOR DID NOT RELEASE THE CLIP CORRECTLY ONTO THE VESSEL AND CAUSED VESSEL DAMAGE. THE CLIP DETACHED FROM THE VESSEL A FEW MINUTES AFTER APPLICATION. THERE WAS POST-SURGICAL HEMORRHAGE, DELAY IN SURGERY WITH SURGICAL TIME EXTENDED BY 30 MINUTES OR MORE. THE PATIENT WAS TREATED FOR POST-SURGICAL HEMORRHAGE BY REMOVAL OF THE CLIPS, REPLACEMENT WITH SINGLE-USE CLIPS, LIGATION WITH SUTURE, AND CAUTERIZATION OF THE VESSEL USING BIPOLAR ENERGY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24789792 ↗
• MalfunctionApr 6, 2026Device Slipped; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN TRACHEOSTOMY, THE DEVICE WAS APPLIED TO A BLOOD VESSEL. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE APPLICATOR DID NOT RELEASE THE CLIP CORRECTLY ONTO THE VESSEL AND CAUSED VESSEL DAMAGE. THE CLIP DETACHED FROM THE VESSEL A FEW MINUTES AFTER APPLICATION. THERE WAS POST-SURGICAL HEMORRHAGE, DELAY IN SURGERY WITH SURGICAL TIME EXTENDED BY 30 MINUTES OR MORE. THE PATIENT WAS TREATED FOR POST-SURGICAL HEMORRHAGE BY REMOVAL OF THE CLIPS, REPLACEMENT WITH SINGLE-USE CLIPS, LIGATION WITH SUTURE, AND CAUTERIZATION OF THE VESSEL USING BIPOLAR ENERGY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24789698 ↗
• MalfunctionApr 6, 2026Device Slipped; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN TRACHEOSTOMY, THE DEVICE WAS APPLIED TO A BLOOD VESSEL. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE APPLICATOR DID NOT RELEASE THE CLIP CORRECTLY ONTO THE VESSEL AND CAUSED VESSEL DAMAGE. THE CLIP DETACHED FROM THE VESSEL A FEW MINUTES AFTER APPLICATION. THERE WAS POST-SURGICAL HEMORRHAGE, DELAY IN SURGERY WITH SURGICAL TIME EXTENDED BY 30 MINUTES OR MORE. THE PATIENT WAS TREATED FOR POST-SURGICAL HEMORRHAGE BY REMOVAL OF THE CLIPS, REPLACEMENT WITH SINGLE-USE CLIPS, LIGATION WITH SUTURE, AND CAUTERIZATION OF THE VESSEL USING BIPOLAR ENERGY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24789639 ↗
• MalfunctionApr 6, 2026Device Slipped; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN TRACHEOSTOMY, THE DEVICE WAS APPLIED TO A BLOOD VESSEL. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE APPLICATOR DID NOT RELEASE THE CLIP CORRECTLY ONTO THE VESSEL AND CAUSED VESSEL DAMAGE. THE CLIP DETACHED FROM THE VESSEL A FEW MINUTES AFTER APPLICATION. THERE WAS POST-SURGICAL HEMORRHAGE, DELAY IN SURGERY WITH SURGICAL TIME EXTENDED BY 30 MINUTES OR MORE. THE PATIENT WAS TREATED FOR POST-SURGICAL HEMORRHAGE BY REMOVAL OF THE CLIPS, REPLACEMENT WITH SINGLE-USE CLIPS, LIGATION WITH SUTURE, AND CAUTERIZATION OF THE VESSEL USING BIPOLAR ENERGY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24789572 ↗
• MalfunctionApr 3, 2026Device Slipped; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN TRACHEOSTOMY, THE DEVICE WAS APPLIED TO A BLOOD VESSEL. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE APPLICATOR DID NOT RELEASE THE CLIP CORRECTLY ONTO THE VESSEL AND CAUSED VESSEL DAMAGE. THE CLIP DETACHED FROM THE VESSEL A FEW MINUTES AFTER APPLICATION. THERE WAS POST-SURGICAL HEMORRHAGE, DELAY IN SURGERY WITH SURGICAL TIME EXTENDED BY 30 MINUTES OR MORE. THE PATIENT WAS TREATED FOR POST-SURGICAL HEMORRHAGE BY REMOVAL OF THE CLIPS, REPLACEMENT WITH SINGLE-USE CLIPS, LIGATION WITH SUTURE, AND CAUTERIZATION OF THE VESSEL USING BIPOLAR ENERGY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24781694 ↗
• MalfunctionMar 30, 2026Difficult to Open or Close; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN PROCEDURE, THE CLIP APPLIER HAD JAWS THAT WERE NOT ABLE TO CLOSE WHEN THE HANDLE WAS SQUEEZED AND THERE WAS AN ISSUE WITH LOADING OR FIRING OF THE CLIPS, WHERE SOME CLIPS COULD LOAD AND SOME COULD BE FIRED. ANOTHER CLIP APPLIER WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729257 ↗
• MalfunctionMar 30, 2026Device Slipped; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN TRACHEOSTOMY PROCEDURE, THE DEVICE WAS APPLIED TO A BLOOD VESSEL. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE APPLICATOR DID NOT RELEASE THE CLIP CORRECTLY ONTO THE VESSEL AND CAUSED VESSEL DAMAGE. THE CLIP DETACHED FROM THE VESSEL A FEW MINUTES AFTER APPLICATION. THERE WAS POST-SURGICAL HEMORRHAGE, DELAY IN SURGERY WITH SURGICAL TIME EXTENDED BY 30 MINUTES OR MORE. THE PATIENT WAS TREATED FOR POST-SURGICAL HEMORRHAGE BY REMOVAL OF THE CLIPS, REPLACEMENT WITH SINGLE-USE CLIPS, LIGATION WITH SUTURE, AND CAUTERIZATION OF THE VESSEL USING BIPOLAR ENERGY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24727263 ↗
• MalfunctionMar 30, 2026Device Slipped; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN TRACHEOSTOMY PROCEDURE, THE DEVICE WAS APPLIED TO A BLOOD VESSEL. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE; THE APPLICATOR DID NOT RELEASE THE CLIP CORRECTLY ONTO THE VESSEL AND CAUSED VESSEL DAMAGE. THE CLIP DETACHED FROM THE VESSEL A FEW MINUTES AFTER APPLICATION. THE EVENT LED TO HEMORRHAGE. THE CLIPS WERE REMOVED FROM THE OPERATING FIELD AND REPLACED WITH DISPOSABLE CLIPS, LIGATION WITH WIRE AND VESSEL CAUTERIZATION. SURGICAL TIME WAS EXTENDED AS A RESULT OF THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24727211 ↗
• MalfunctionFeb 24, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A VASCULAR SURGERY PROCEDURE, THE CLIP APPLIER WAS APPLIED TO TISSUE USING AN OPEN PROCEDURE. THE SURGEON PARTIALLY COMPRESSED THE APPLICATOR TO POSITION THE CLIP, BUT UPON FULL COMPRESSION TO DEPLOY THE CLIP, THE CLIP DID NOT FORM PROPERLY. THE ISSUE WAS RESOLVED BY OPENING A NEW CLIP APPLIER TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24426745 ↗
• InjuryFeb 16, 2026Device Slipped

  IT WAS REPORTED THAT ONE HOUR AND THIRTY MINUTES AFTER THE END OF PAROTIDECTOMY, WHEREIN TWO CLIPS WERE APPLIED, THE CLIPS DID NOT HOLD, NECESSITATING THE INSERTION OF SEVERAL CLIPS FOR SIMPLE VESSEL LIGATION. THIS RESULTED IN HEMORRHAGE AND THE FORMATION OF A COMPRESSING HEMATOMA ON THE FACIAL NERVE. THE PATIENT FACED A SIGNIFICANT RISK OF FACIAL NERVE PARALYSIS. ADDITIONALLY, THERE WAS A LOSS OF TIME DURING THE PROCEDURE, AND THE EVENT LED TO AN EXTENSION OF THE PATIENT¿S HOSPITALIZATION.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24356739 ↗
• MalfunctionJan 30, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN ORAL CAVITY PHARYNX RADICAL SURGERY PLUS MICROSURGICAL PLASTIC SURGERY, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT NONE OF THE CLIPS WOULD LOAD INTO THE JAWS. THE CLIPS WOULD NOT COME OUT OF THE APPLICATOR EVEN WHEN PRESSED REPEATEDLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222834 ↗