Premium Plus CEEARecalls & reported problems across all models
Covidien LP · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 413
- Deaths reported
- 0
- Injuries reported
- 180
- Recalls
- 0
We found 5 models of Premium Plus CEEA 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 Apr 5, 2016 and Jan 9, 2026 — classified as 180 injuries, 233 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (111 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 Plus CEEA problems
Device problems
- Failure to Form Staple111
- Difficult to Remove83
- Failure to Fire78
- Misfire53
- Failure to Cut52
- Detachment of Device or Device Component41
- Adverse Event Without Identified Device or Use Problem27
- Mechanics Altered23
Patient problems
- No Code Available120
- No Known Impact Or Consequence To Patient83
- No Consequences Or Impact To Patient73
- No Clinical Signs, Symptoms or Conditions58
- Tissue Damage51
- Unspecified Tissue Injury50
- Failure to Anastomose42
- Hemorrhage/Blood Loss/Bleeding8
Premium Plus CEEA models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Premium Plus CEEA 111987STAPLE, IMPLANTABLE151 reports
- Premium Plus CEEA 111989STAPLE, IMPLANTABLE129 reports
- Premium Plus CEEA 111985STAPLE, IMPLANTABLE114 reports
- Premium Plus CEEA 111983STAPLE, IMPLANTABLE12 reports
- Premium Plus CEEA 111981STAPLE, IMPLANTABLE7 reports
Recent Premium Plus CEEA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2026Failure to Fire
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER DID NOT FIRE. REPEATED ATTEMPTS TO FIRE HAVE FAILED. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24026729 ↗MalfunctionDec 17, 2025Misfire; Misfire
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FIRING OF THE CIRCULAR STAPLER WAS FAULTY. A NEW DEVICE OF THE SAME MODEL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831747 ↗MalfunctionMay 21, 2025Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, LAPAROSCOPIC RADICAL RECTAL CANCER SURGERY, WHILE ON RECTAL GASTROINTESTINAL RECONSTRUCTION, THE STAPLE WAS NOT IN FULL B CLOSURE. THE SURGEON OVERSEWED TO FIX THE STAPLE LINE.
Patient problems: Failure to Anastomose
MAUDE report 22064598 ↗MalfunctionFeb 26, 2025Failure to Fire; Expulsion; Failure to Fire; Expulsion
IT WAS REPORTED THAT PREOPERATIVELY, THE HANDLE WAS NOT FULLY SQUEEZED UNTIL IT CAME IN CONTACT WITH THE INSTRUMENT BODY. HENCE, WHILE TRYING TO FIRE, THE INSTRUMENT DID NOT FIRE AND IT PRE-FIRED. TO RESOLVE THE ISSUE, A NEW CIRCULAR STAPLER WAS USED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21471698 ↗MalfunctionFeb 7, 2025Failure to Fire; Expulsion; Failure to Fire; Expulsion
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE WAS PRE-FIRED. THE DEVICE COULD NOT BE FIRED. THE HANDLE COULD NOT BE FULLY SQUEEZED UNTIL IT CAME IN CONTACT WITH THE INSTRUMENT BODY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21337822 ↗MalfunctionJan 6, 2025Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A RADICAL RESECTION OF RIGHT HEMICOLON CANCER, WHEN THE DEVICE WAS BEING APPLIED TO THE END-TO-END ANASTOMOSIS THE STAPLE LINE WAS INCOMPLETE. THE ANASTOMOTIC STOMA WAS MANUALLY SUTURED TO RESOLVE THE ISSUE.
Patient problems: Failure to Anastomose; Tissue Breakdown
MAUDE report 21081467 ↗MalfunctionNov 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, DURING RECTAL ANASTOMOSIS, WHEN FIRING, THE SURGEON FELT AS IF THE DEVICE WAS DISLODGED DURING NEEDLE INSERTION. GIVING THE IMPRESSION THAT IT HAS NOT BEEN FIRED FIRMLY. THE WING NUT WAS TURNED TWICE TO TILT THE ANVIL, BUT SINCE IT WAS TURNED MORE THAN TWO TIMES, THE ANVIL CAME OFF WHEN THE ANASTOMOSIS DEVICE WAS REMOVED. THE DONUT RING WAS CONFIRMED TO BE COMPLETE SO THE OPERATION WAS COMPLETED WITH THE SAME STAPLER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20610593 ↗MalfunctionSep 18, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20248936 ↗MalfunctionJul 23, 2024Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RESECTION OF RECTAL CANCER PROCEDURE, WHILE PERFORMING RECTAL ANASTOMOSIS, THERE WAS POOR STAPLE FORMATION AFTER FIRING. ANOTHER CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE.
Patient problems: Failure to Anastomose
MAUDE report 19813062 ↗MalfunctionJun 21, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL CANCER SURGERY, ON INTESTINAL ANASTOMOSIS, THE PUNCTURE DEVICE TIP CRACKED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19584561 ↗MalfunctionMay 9, 2024Loss of or Failure to Bond; Material Twisted/Bent; Positioning Problem; Loss of or Failure to Bond; Material Twisted/Bent; Positioning Problem
ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC TOTAL GASTRIC SURGERY, WHEN THE STOMACH AND DUODENUM WERE ANASTOMOSED, THE INSTRUMENT ROD WAS ON THE STOMACH SIDE AND THE ANVIL WAS ON THE DUODENUM. THE ANVIL WAS BENT BEFORE FIRING CAUSING THE INSTRUMENT FAILED TO DOCK. IT WAS NOTED THAT UNUSUAL EFFORT WAS REQUIRED TO TURN THE TWIST KNOB IN ORDER TO VISUALIZE THE GREEN BAR. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19281718 ↗MalfunctionMar 13, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING AN OPEN REVERSAL HARTMAN, THE STAPLER MISFIRED AND HAD AN ISSUE WITH THE SAFETY. THE DEVICE DID NOT FIRE. A STAPLER FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18894971 ↗MalfunctionMar 7, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE CIRCULAR STAPLER DID NOT FIRE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18861543 ↗InjuryFeb 22, 2024Mechanics Altered; Mechanics Altered
ACCORDING TO THE REPORTER, DURING A COLOSTOMY REVERSAL, AFTER AN OPEN ANTERIOR RESECTION, THE STAPLER CUT THE RECTUM TISSUES WITHOUT FIRING THE STAPLES. THERE WAS A BLOOD LOSS OF MORE THAN 500CC AND SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THE SURGEON MANUALLY SUTURED THE TISSUE, AND THE PROCEDURE WAS CANCELLED DUE TO THE DEVICE MALFUNCTION AND CONNECTED TO THE PREVIOUS PATH OF COLOSTOMY. THE PATIENT SHOULD HAVE STAYED IN THE INTENSIVE CARE UNIT FOR 3 TO 5 DAYS, BUT THE PATIENT WAS STILL IN THE INTENSIVE CARE UNIT AFTER SIX DAYS.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 18763878 ↗MalfunctionJan 8, 2024Failure to Cut; Detachment of Device or Device Component; Failure to Cut; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE ANVIL OF THE DEVICE DISENGAGED INTO THE PATIENT'S CAVITY. THE ANVIL WAS REMOVED USING A SNARE. IT WAS ALSO REPORTED THAT THE ANVIL COULD NOT BE TILTED AS THE ANVIL WAS HELD UP BY TISSUE THAT WAS NOT CUT THROUGH. THE DEVICE DID NOT CUT FULLY THROUGH THE TISSUE, BUT THE STAPLE LINES OUTLINING THE DONUTS WERE INTACT. A HOT SNARE WAS USED TO LASSO AND FULGURATE THE AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown
MAUDE report 18472331 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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