Premium SurgiclipRecalls & reported problems across all models
Covidien LP · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 413
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls
- 0
We found 4 models of Premium Surgiclip by Covidien LP in the FDA's device registry (GUDID). Together they are named in 413 adverse event reports in the FDA's MAUDE database, received between Mar 15, 2017 and Dec 30, 2025 — classified as 35 injuries, 378 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (247 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
Reports received per month, all models
Most reported Premium Surgiclip problems
Device problems
- Mechanics Altered247
- Mechanical Problem153
- Material Deformation35
- Device Slipped30
- Detachment of Device or Device Component26
- Difficult to Open or Close25
- Failure to Fire12
- Display or Visual Feedback Problem8
Patient problems
- No Known Impact Or Consequence To Patient131
- No Clinical Signs, Symptoms or Conditions117
- No Consequences Or Impact To Patient88
- Insufficient Information25
- No Code Available17
- No Information17
- No Patient Involvement16
- Tissue Damage15
Premium Surgiclip models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Premium Surgiclip 134048CLIP, IMPLANTABLE159 reports
- Premium Surgiclip 134031CLIP, IMPLANTABLE134 reports
- Premium Surgiclip 134044CLIP, IMPLANTABLE83 reports
- Premium Surgiclip 134046CLIP, IMPLANTABLE37 reports
Recent Premium Surgiclip adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND SOME CLIPS WERE MALFORMED.
Patient problems: Insufficient Information
MAUDE report 23930744 ↗MalfunctionDec 17, 2025Device Slipped; Device Slipped
IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE, THE DEVICE WAS NOT WORKING PROPERLY AS THE CLIPS WERE FALLING OUT. TO RESOLVE THE ISSUE, A NEW DEVICE OF THE SAME TYPE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23832513 ↗MalfunctionSep 2, 2025Entrapment of Device; Mechanics Altered; Entrapment of Device; Mechanics Altered
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE CLIPS WERE UNABLE TO LOAD PROPERLY INTO THE JAWS. IT WAS NOTED TISSUES BECAME STUCK TO THE DEVICES WHEN PULLING, AND THE CLIP REMAINED ATTACHED TO THE DEVICE, WHICH TORE THE VESSEL AFTER CLIPPING IN THE THREE DEVICES.
Patient problems: Tissue Breakdown
MAUDE report 22945981 ↗MalfunctionSep 2, 2025Entrapment of Device; Mechanics Altered; Entrapment of Device; Mechanics Altered
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE CLIPS WERE UNABLE TO LOAD PROPERLY INTO THE JAWS. IT WAS NOTED TISSUES BECAME STUCK TO THE DEVICES WHEN PULLING, AND THE CLIP REMAINED ATTACHED TO THE DEVICE, WHICH TORE THE VESSEL AFTER CLIPPING IN THE THREE DEVICES.
Patient problems: Tissue Breakdown
MAUDE report 22945942 ↗MalfunctionJul 29, 2025Break; Material Deformation; Break; Material Deformation
ACCORDING TO THE REPORTER DURING AN OPEN LIPECTOMY PROCEDURE, THE CLIPS CROSSED AND BROKE OFF. THIS ISSUE OCCURRED ON TWO DEVICES. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644436 ↗MalfunctionJul 29, 2025Break; Material Deformation; Break; Material Deformation
ACCORDING TO THE REPORTER DURING AN OPEN LIPECTOMY PROCEDURE, THE CLIPS CROSSED AND BROKE OFF. THIS ISSUE OCCURRED ON TWO DEVICES. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644398 ↗MalfunctionJul 28, 2025Mechanics Altered; Mechanics Altered
IT WAS REPORTED THAT PRE-OPERATIVELY, ISSUES WERE EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS FOR THE CLIP APPLIER. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22637092 ↗MalfunctionJun 9, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING AN OPEN CYSTECTOMY, WHILE CLIPPING THE VASCULAR STRUCTURES, THE HANDLE WAS SQUEEZED AND SOME OF THE CLIPS FROM THE TWO DEVICES CAME OUT MALFORMED. THE MALFORMED CLIPS WERE REMOVED, AND NEW DEVICES WERE OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22172086 ↗MalfunctionJan 28, 2025Mechanics Altered; Mechanics Altered
IT WAS REPORTED THAT PREOPERATIVELY, THERE WERE ISSUES EXPERIENCED WITH THE LOADING OR FIRING OF THE TITANIUM CLIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21253381 ↗MalfunctionDec 27, 2024Mechanical Problem; Mechanical Problem
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE CLIP APPLIER WOULD NOT FOLD THE STAPLER DOWN WHEN IT WAS FIRED.
Patient problems: Insufficient Information
MAUDE report 21026391 ↗MalfunctionOct 14, 2024Mechanical Problem; Mechanical Problem
ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY PROCEDURE, THE DEVICE WAS UNABLE TO CLIP AND WERE ALREADY BENT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20447177 ↗MalfunctionAug 13, 2024Mechanics Altered; Mechanics Altered
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE CLIP APPLIER GOT STUCK AFTER THE FIRST CLIP AND WAS UNABLE TO DELIVER THE FOLLOWING CLIPS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19973810 ↗MalfunctionJun 28, 2024Device Slipped; Device Slipped
ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL HIP PROSTHESIS PROCEDURE, SEVERAL CLIPS WERE USED IN WHICH IT DETACHED AND DID NOT R EMAIN ATTACHED TO THE BLOOD VESSELS. THE SURGICAL TIME WAS EXTENDED BY TEN MINUTES. THE CLIP APPLIER WAS CHANGED TO A DIFFERENT LOT NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19633057 ↗MalfunctionFeb 16, 2024Mechanical Problem; Fail-Safe Problem; Mechanical Problem; Fail-Safe Problem
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE FIRST CLIP WAS MALFORMED. THE CLIP WAS ALREADY FOLDED BEFORE IT WAS EVEN TAKEN OUT. IT WAS ALSO MENTIONED THAT THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE WHEN THE ISSUE OCCURRED AFTER THE CLIP MALFORMATION. ANOTHER CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18726134 ↗MalfunctionFeb 9, 2024Mechanical Problem; Mechanical Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGEAL CANCER PROCEDURE, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THE ISSUE OCCURRED IN TWO SETS OF HANDLES AND RELOADS. THE CLIP APPLIER WAS ABLE TO FIRE. HOWEVER, THE CLIP WAS MALFORMED. THE ORVIL ANVIL WAS DIFFICULT TO LOAD INTO THE DEVICE. NEW DEVICES WERE USED TO RESOLVE THE ISSUE. THE SAME CIRCULAR HANDLE WAS USED WITH THE NEW ORVIL ANVIL. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18680369 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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