Premium Surgiclip IIRecalls & reported problems across all models

We found 2 models of Premium Surgiclip II by Covidien LP in the FDA's device registry (GUDID). Together they are named in 562 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2017 and Sep 30, 2026 — classified as 34 injuries, 528 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (353 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Premium Surgiclip II problems

Premium Surgiclip II models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Premium Surgiclip II 134051

  CLIP, IMPLANTABLE
  306 reports
• Premium Surgiclip II 134053

  CLIP, IMPLANTABLE
  256 reports

Recent Premium Surgiclip II adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952170 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936571 ↗
• MalfunctionSep 29, 2026Mechanics Altered

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

  MAUDE report 50933622 ↗
• MalfunctionSep 29, 2026Mechanics Altered

  It was reported that during a procedure, the surgeon attempted to clip a vessel, the clip applier did not reload when the surgeon attempted to apply a clip. The clip applier damaged the vessel, resulting in bleeding and tissue damage. To resolve the issue, the device was replaced.

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

  MAUDE report 50927059 ↗
• MalfunctionSep 11, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742635 ↗
• MalfunctionSep 11, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742501 ↗
• MalfunctionJun 30, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A CLIP APPLIER WAS USED AND THE CLIP DID NOT BITE WELL. TO RESOLVE THE ISSUE, A NEW CLIP APPLIER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25671125 ↗
• MalfunctionJun 9, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING AN OPEN BREAST RECONSTRUCTION PROCEDURE, WHEN THE CLIP APPLIER WAS APPLIED TO BREAST TISSUE DURING DISSECTION. THE HANDLE WAS ABLE TO BE SQUEEZED AND THE JAWS WERE ABLE TO CLOSE AND THERE WAS A CLIP FORMATION. NOTHING WAS DONE TO RESOLVE THE ISSUE IN ORDER 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 25448910 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component; Material Deformation; Mechanics Altered; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PREMIUM CLIP APPLIER WAS USED DURING AN OPEN MASTECTOMY AND RECONSTRUCTION WITH FLAPS WHEN THE PHYSICIAN ATTEMPTED TO CLIP VESSELS DURING THE MASTECTOMY. A CLIP LOADING OR FIRING ISSUE WAS REPORTED, AND THE CLIPS WERE DESCRIBED AS MALFORMED IN A Y-SHAPE WHEN RELEASED/DEPLOYED. CLIPS WERE REPORTED TO HAVE DISENGAGED AND FALLEN INTO THE PATIENT CAVITY AFTER DEPLOYMENT; THE CLIPS WERE VISIBLE AND WERE RETRIEVED WITH AN INSTRUMENT. TO COMPLETE THE PROCEDURE, ANOTHER DEVICE FROM THE SAME LOT WAS OPENED AND HAD THE SAME ISSUE, AND THEN ANOTHER CLIP APPLIER FROM A DIFFERENT LOT WAS OPENED AND WORKED AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25403200 ↗
• MalfunctionApr 28, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS SURGERY (CABG), DURING BLOOD VESSEL TREATMENT, WHEN LOADING THE CLIP, THE CLIP PROTRUDES OUT OF THE JAW. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022114 ↗
• MalfunctionApr 28, 2026

  MEDIUM CLIP DID NOT FIRE CORRECTLY. THE CLIP SCISSORED AND DID NOT CLAMP THE VESSEL PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014561 ↗
• MalfunctionApr 23, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN WIDE LOCAL EXCISION (WLE) WITH SENTINEL LYMPH NODE BIOPSY (SNB), THE CLIPS ABLE TO LOAD PROPERLY INTO THE JAWS. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE WHEN THE ISSUE OCCURRED. A NEW APPLIER WAS OPENED 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 24969056 ↗
• InjuryApr 20, 2026Device Slipped

  IT WAS REPORTED THAT DURING AN OPEN PROCEDURE, THE CLIP FAILED AFTER THE PROCEDURE BECAUSE IT DID NOT REMAIN ON THE PATIENT. THE PATIENT EXPERIENCED A HEMORRHAGE DUE TO CLIP DISLODGEMENT, WHICH REQUIRED AN URGENT POSTOPERATIVE RE-OPERATION. ANOTHER CLIP WAS USED TO COMPLETE THE CASE.

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

  MAUDE report 24933937 ↗
• MalfunctionApr 17, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING AN OPEN VASCULAR SURGICAL PROCEDURE, SOME OF THE CLIPS DID NOT FORM PROPERLY. THE CASE WAS COMPLETED BY USING MORE CLIPS OF THE SAME REFERENCE. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911327 ↗
• MalfunctionApr 16, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A TOTAL PANCREATECTOMY, THE CLIP WAS NOT LOADING.

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

  MAUDE report 24903936 ↗

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