INSORB 2030Recalls & reported problems
Coopersurgical, Inc. · INSORB Subcuticular Skin Stapler REF2030 (each) · Class 2 · Implant
Quick summary
This CooperSurgical INSORB skin stapler has 107 reports, no deaths and 53 injuries. Many reports describe wounds reopening after closure with the stapler, and some describe the stapler jamming, misfiring or failing to fire. There was 1 recall, now closed, started in August 2018 because the sterile packaging may not have been fully sealed.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 107
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00867516000104), received between Apr 14, 2017 and Mar 26, 2026 — classified as 53 injuries, 54 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (11 reports).
1 FDA recall record name this device's identifier.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Aug 29, 2018Terminated
Possible compromise of the sterile barrier integrity
Z-0078-2019 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem53
- Mechanical Jam11
- Mechanical Problem10
- Failure to Fire6
- Misfire6
- Therapeutic or Diagnostic Output Failure5
- Insufficient Device Problem Information4
- Defective Device3
Patient problems
- Wound Dehiscence58
- No Clinical Signs, Symptoms or Conditions25
- Insufficient Information14
- No Known Impact Or Consequence To Patient7
- Post Operative Wound Infection4
- Edema3
- Impaired Healing3
- Adhesion(s)2
Recent adverse event reports
The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY AND EXPERIENCED A PARTIAL WOUND DEHISCENCE WITHIN 24 HOURS POST CLOSURE. PATIENT WAS RETURNED TO SURGERY FOR CLOSURE. ATTEMPTS WERE MADE, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).
Patient problems: Wound Dehiscence
MAUDE report 24688644 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE CESAREAN SECTION AT (B)(6) MEDICAL CENTER, IN WHICH THE INSORB STAPLER WAS USED FOR SURGICAL SITE CLOSURE. APPROXIMATELY 48 HOURS POST-OPERATION THE PATIENT EXPERIENCED WOUND SEPARATION AND REQUIRED SUTURES. ACCORDING TO THE SURGICAL TEAMS, THE DEVICE WAS USED IN ACCORDANCE WITH THE IFU AND STANDARD CLINICAL PRACTICE. PATIENT DID NOT HAVE OBESITY OR DIABETES. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Wound Dehiscence
MAUDE report 24562994 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
PATIENT 2/4: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN WHICH THE INSORB STAPLER WAS USED FOR SURGICAL SITE CLOSURE. APPROXIMATELY 48 HOURS POST-OPERATION THE PATIENT EXPERIENCED WOUND SEPARATION AND REQUIRED SUTURES. ACCORDING TO THE SURGICAL TEAMS, THE DEVICE WAS USED IN ACCORDANCE WITH THE IFU AND STANDARD CLINICAL PRACTICE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NONE WAS MADE AVAILABLE. 2030 INSORB (B)(4).
Patient problems: Wound Dehiscence
MAUDE report 24562992 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence
MAUDE report 24213347 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
InjuryOct 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAESAREAN-SECTION DELIVERY ON AN UNKNOWN DATE AND INSORB STAPLES WERE USED FOR CLOSURE. THE SURGICAL SITE DEHISCED AND REQUIRED SUTURING. ATTEMPTS HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(4).
Patient problems: Wound Dehiscence
MAUDE report 23351951 ↗InjuryOct 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAESAREAN-SECTION DELIVERY AND INSORB STAPLES WERE USED. THE SURGICAL SITE DEHISCED AND REQUIRED SUTURING. ATTEMPTS HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 2030 INSORB (B)(4).
Patient problems: Wound Dehiscence
MAUDE report 23351000 ↗InjuryOct 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryOct 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAESAREAN-SECTION DELIVERY ON AN UNKNOWN DATE AND INSORB STAPLES WERE USED FOR CLOSURE. THE SURGICAL SITE DEHISCED AND REQUIRED SUTURING. ATTEMPTS HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 2030 INSORB (B)(4).
Patient problems: Wound Dehiscence
MAUDE report 23350998 ↗InjurySep 16, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABDOMINAL SURGERY IN (B)(6) 2025. SURGEON USED ROBOTICS AND CLOSED WITH INSORB STAPLES. STAPLES BEGAN TO EXPEL FROM BODY AND THE SURGEON REMOVED 5-6 STAPLES FROM NAVAL INCISION IN OFFICE ON (B)(6) 2025. EMPIRIC ANTIBIOTIC TREATMENT ADMINISTERED. 1216677-2025-00039, 2030 INSORB, (B)(4).
Patient problems: Abdominal Pain
MAUDE report 23065139 ↗InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND THE INSORB STAPLER WAS USED. SEVERAL HOURS POST-OP, THE PATIENT EXPERIENCED WOUND DEHISCENCE. DEVICE WAS DISCARDED. MULTIPLE ATTEMPTS WERE MADE, BUT NO ADDITIONAL INFORMATION IS AVAILABLE. 2030 INSORB (B)(4).
Patient problems: Wound Dehiscence
MAUDE report 21323684 ↗InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND THE INSORB STAPLER WAS USED. SEVERAL HOURS POST-OP, THE PATIENT EXPERIENCED WOUND DEHISCENCE. DEVICE WAS DISCARDED. MULTIPLE ATTEMPTS WERE MADE, BUT NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2025-00008 2030 INSORB 2025-01-0000172.
Patient problems: Wound Dehiscence
MAUDE report 21323683 ↗InjuryJan 29, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAESAREAN SECTION DELIVERY ON (B)(6) 2024 IN WHICH THE INSORB STAPLES WERE USED. PATIENT WAS CHECKED EIGHT HOURS POST-OP AND FOUND TO BE FINE WITH NO BLEEDING. PATIENT WAS MOBILIZED AT TEN HOURS POST-OP AND THE ENTIRE WOUND OPENED UP AS IF THERE WAS NOTHING HOLDING THE WOUND CLOSED AT ALL. DOCTOR HAD TO CLOSE THE WOUND AGAIN WITH VICRYL SUTURE AND THERE WAS NO STAPLES HOLDING THE WOUND TOGETHER. NO ADDITIONAL INFORMATION AVAILABLE. 2030 INSORB (B)(4).
Patient problems: Wound Dehiscence
MAUDE report 21265426 ↗InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20582663 ↗InjuryAug 29, 2024Expulsion; Patient Device Interaction Problem; Expulsion; Patient Device Interaction Problem
NO ADDITIONAL INFORMATION.
Patient problems: High White Blood Cell Count; Impaired Healing; Sepsis; Seroma; Unspecified Infection; Wound Dehiscence
MAUDE report 20098845 ↗InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAESARIAN SECTION PROCEDURE ON (B((6) 2023. DOCTOR STATES THAT THE STAPLES KEEP COMING UP THROUGH THE SURFACE OF THE SKIN AND NEED TO BE REMOVED. PATIENT INCURRED MASSIVE INFECTION AS WELL AS TWO TRIPS TO THE ER. DOCTOR INQUIRED AS TO THE STAPLE ABSORPTION TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2023-00159 2030 INSORB STAPLER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18324951 ↗InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18046885 ↗InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CASE 6/8 HOSPITAL HAS REPORTED AN INVESTIGATION INTO AN INCREASED RATE OF SURGICAL SITE INFECTIONS (SSI) RELATED TO CAESAREAN SECTIONS. IT WAS REPORTED THAT 8 RECENT CASES, ALL INSORB C-SECTION CLOSURES, RESULTED IN SSI'S. MAJORITY OF DOCTORS USE THE INSORB STAPLER FOR C-SECTIONS. THIS WAS A NOTICEABLE UPTICK IN DEPARTMENT INFECTION RATE. AFTER INVESTIGATION, THE HOSPITAL DOES NOT BELIEVE THAT THE INSORB STAPLER WAS THE CAUSAL FACTOR IN THESE CASES. RATHER, THEY BELIEVE THAT THE ISSUES STEM FROM LAPSES IN STERILITY AND INFECTION CONTROL MEASURES AS PRACTICED BY THEIR STAFF. HOSPITAL IS CORRECTING THROUGH RE-EDUCATION AND ENHANCED GUIDELINES. STAPLERS ARE NOT BEING RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE. 2030 INSORB STAPLER 2023-10-0000423.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18046877 ↗InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18046876 ↗InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18046875 ↗
Other Staple, Implantable devices
- Endo GIA EGIA60AMTCovidien LP · STAPLE, IMPLANTABLE19 deaths10,680 reports
- Endo GIA Ultra EGIAUSTNDCovidien LP · STAPLE, IMPLANTABLE5 deaths9,730 reports
- Signia SIGPHANDLECovidien LP · STAPLE, IMPLANTABLE1 recall3 deaths5,356 reports
- ECHELON FLEX PSEE60AEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE1 recall13 deaths3,294 reports
- Endo GIA Ultra EGIAUSHORTCovidien LP · STAPLE, IMPLANTABLE2 deaths3,011 reports
- Endo GIA EGIA45AMTCovidien LP · STAPLE, IMPLANTABLE10 deaths2,965 reports
- Endo GIA Ultra EGIAUXLCovidien LP · STAPLE, IMPLANTABLE2,909 reports
- ENDOPATH ATS45Ethicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE2 deaths2,046 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.