PurstringRecalls & reported problems across all models
Covidien LP · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 127
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 2 models of Purstring by Covidien LP in the FDA's device registry (GUDID). Together they are named in 127 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2017 and Sep 15, 2026 — classified as 7 injuries, 120 malfunctions.
The most frequently reported specific device problem is “Break” (43 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 Purstring problems
Device problems
- Break43
- Failure to Fire30
- Detachment of Device or Device Component18
- Failure to Form Staple15
- Entrapment of Device11
- Difficult to Open or Close8
- Misfire7
- Adverse Event Without Identified Device or Use Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- Insufficient Information16
- No Known Impact Or Consequence To Patient16
- No Consequences Or Impact To Patient10
- Tissue Breakdown6
- Unspecified Tissue Injury5
- Failure to Anastomose4
- Hemorrhage/Blood Loss/Bleeding3
Purstring models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Purstring 020242CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY81 reports
- Purstring 020730CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY46 reports
Recent Purstring adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Misfire
It was reported that during the procedure, the purstring stapler failed during use. The device was replaced with a new product. No consequences or impact to the patient were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766611 ↗MalfunctionApr 7, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC LOW ANTERIOR RESECTION, DURING ANASTOMOSIS, THE ANVIL AND RELOAD OF THE CIRCULAR STAPLER WERE FULLY CONNECTED BUT THERE WERE HOLES IN THE STAPLE LINE. THE SECOND DEVICE WAS FIRED AND THERE WAS A STAPLE LINE BLEEDING. THE SURGEON RESECTED AND RESTAPLED THE ANASTOMOSIS TO RESOLVE THE ISSUE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24799099 ↗MalfunctionMar 4, 2026Failure to Fire
IT WAS REPORTED THAT DURING A PROCEDURE, AT THE BEGINNING, THE DEVICE DID NOT FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508242 ↗MalfunctionFeb 16, 2026Misfire
IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE EXPERIENCED FIRING ISSUES. THE DEVICE WAS REPLACED WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24349214 ↗MalfunctionDec 11, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING THE COLECTOMY, THE STAPLES WENT THROUGH TISSUE BUT NEVER FORMED. ANOTHER PURSE STRING DEVICE WAS OPENED AND USED SUCCESSFULLY.
Patient problems: Tissue Breakdown
MAUDE report 23783164 ↗MalfunctionOct 31, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING THE PROCEDURE, THE PURSE STRING WOULD NOT CLOSE DURING USE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 23441979 ↗MalfunctionSep 16, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE, WHILE ON THE PURSTRING OF THE COLON, AFTER FIRING THE DEVICE, A SUTURE BREAK OCCURRED. THE SURGEON RESOLVED THE ISSUE BY REPLACING THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23063024 ↗MalfunctionJul 9, 2025Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE ANASTOMOTIC SITE WAS FIRMLY SQUEEZED/SECURED WITH THE PURSE STRING, BUT PART OF THE SUTURE WAS NOT CAUGHT, AND THERE WAS ENOUGH SPACE TO FIT A FORCEPS IN. ADDITIONAL SUTURE WAS PERFORMED BY HAND SEWING.
Patient problems: Failure to Anastomose
MAUDE report 22465571 ↗MalfunctionJun 23, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A SIGMOIDECTOMY PROCEDURE, THE INSTRUMENT DID NOT FIRE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE AND USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22312375 ↗MalfunctionJun 20, 2025Misfire; Failure to Fire; Misfire; Failure to Fire
ACCORDING TO THE REPORTER, THE DEVICE HAD FAULTY FIRING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22298586 ↗MalfunctionJun 18, 2025Material Frayed; Misfire; Material Deformation; Material Frayed; Misfire; Material Deformation
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A PROBLEM WITH THE FIRING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283440 ↗MalfunctionApr 30, 2025Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, SUTURE WAS BROKEN IN PURSE STRING DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21933044 ↗MalfunctionApr 24, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS BROKEN BEFORE BEING USED. THE PROBLEM WAS RESOLVED BY REPLACING THE DEVICE WITH ANOTHER DEVICE.
Patient problems: Insufficient Information
MAUDE report 21901387 ↗MalfunctionApr 22, 2025Break; Break
IT WAS REPORTED THAT PRIOR TO USE, THE PURSESTRING BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21883152 ↗MalfunctionFeb 24, 2025Break; Break
IT WAS REPORTED THAT DURING A TRANSIT RECONSTRUCTION PROCEDURE, THE SUTURE BROKE AFTER FIRING. SUTURING WAS DONE AS A STAPLE LINE RE PLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447150 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page