GYNECARE INTERCEED 4350Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031005396), received between Nov 21, 2017 and Aug 7, 2026 — classified as 11 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (5 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175984 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTATIC BARRIER WAS USED. DURING SURGERY, AFTER THE INTERCEED WAS PLACED ON THE SURGICAL WOUND, THE PATIENT EXHIBITED SHOCK SYMPTOMS. THE PRODUCT WAS SUBSEQUENTLY REMOVED, AND EMERGENCY MEASURES WERE TAKEN. THE PATIENT HAS BEEN TRANSFERRED TO THE ICU CURRENTLY, AND IT COULD NOT BE RULED OUT WHETHER THIS EVENT IS RELATED TO THE USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Shock

  MAUDE report 25547749 ↗
• MalfunctionJun 4, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THERE WAS A BLACK SPOT (UNKNOWN SUBSTANCE) APPEARANCE ON THE PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402250 ↗
• MalfunctionAug 28, 2025Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND ABSORBABLE ADHESION BARRIER WAS TO BE USED. THEY HAD TROUBLE OPENING THE PACKAGING OF THE DEVICE. NO PATIENT WAS INVOLVED. AS PER REP "DEVICES WERE CONTAMINATED BECAUSE THEY HAD A HARD TIME OPENING". ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914198 ↗
• MalfunctionAug 28, 2025Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND ABSORBABLE ADHESION BARRIER WAS TO BE USED. THEY HAD TROUBLE OPENING THE PACKAGING OF THE DEVICE. NO PATIENT WAS INVOLVED. AS PER REP "DEVICES WERE CONTAMINATED BECAUSE THEY HAD A HARD TIME OPENING". ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914196 ↗
• MalfunctionJun 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND ABSORBABLE ADHESION BARRIER WAS USED. IT WAS FOUND THAT THERE WAS A SOMETHING LIKE DUST INSIDE THE STERILIZED PACKAGE WHEN TRIED TO USE THE ABSORBABLE ADHESION BARRIER DURING THE OPERATION. THIS EVENT WAS FOUND BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341411 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENTEROSTOMY (AN ILEUS TUBE WAS RETROGRADELY INSERTED INTO THE SMALL INTESTINE) IN THE ICU ON (B)(6) 2025 AND AN ABSORBABLE ADHESION BARRIER WAS APPLIED. ON 2 DAYS AFTER THE SURGERY, THE PATIENT HAD A FEVER OF 39.6 DEGREES AND PERITONEAL IRRITATION SIGN, SO PERITONITIS WAS SUSPECTED AND RE-OPERATION WAS PERFORMED. THE SURGERY WAS AN IRRIGATION AND DRAINAGE OF THE ABDOMINAL CAVITY WHICH WAS CONSISTED OF ONLY REMOVED THE ABSORBABLE ADHESION BARRIER, ABDOMINAL IRRIGATION, AND DRAIN PLACEMENT. FURTHERMORE, AN ABSCESS HAD FORMED ON THE ABSORBABLE ADHESION BARRIER AT THE TIME OF RE-OPERATION. AS A RESULT OF CULTURE, CRE (CARBAPENEM-RESISTANT ENTERO BACTERALES) WAS DETECTED. THE SYMPTOMS BECOME CONVALESCENT FROM AFTER THE SURGERY, AND THERE WERE NO ABNORMALITIES AS OF THE (B)(6) DAY AFTER THE SURGERY. THE DOCTOR'S OPINION ON THE CAUSE OF THIS EVENT WAS THAT BACTERIA REMAINED EVEN AFTER 2 LITERS OF IRRIGATION CAUSED BY EXPOSURED INTESTINAL JUICE WHEN THE ILEUS TUBE WAS INSERTED IN THE SURGERY ON (B)(6), AND IT MIGHT BE LED TO THE INFECTION DUE TO PLACING A FOREIGN OBJECT THERE. THE (B)(6) SURGERY WAS (B)(6) SURGERY FOR THE PATIENT HIMSELF, AND IT

  Patient problems: Abscess; Fever; Inflammation; Unspecified Infection

  MAUDE report 21655329 ↗
• MalfunctionDec 4, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE DEVICE PACKAGE WAS FOUND UNSEALED WHEN UNPACKING. ONE END OF THE PACKAGE IS NOT SEALED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845900 ↗
• MalfunctionSep 20, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT IT WAS FOUND THAT THERE WAS FOREIGN OBJECT ON THE PRODUCT WHEN PREPARING FOR SURGERY. WHEN OPERATOR OPEN THE PRODUCT, THERE WAS AN UNKNOWN OBJECT FALLING DOWN ON THE FLOOR, THE PRODUCT WAS NOT USED AND FOREIGN MATTER (UNKNOWN OBJECT) WAS NOT RETRIEVED FROM FLOOR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268006 ↗
• MalfunctionOct 11, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OVARIAN CYST REMOVAL PROCEDURE ON (B)(6) 2023 AND AN ABSORBABLE ADHESION BARRIER WAS USED. THE DEVICE PACKAGE WAS FOUND UNSEALED WHEN UNPACKING AND COUNTING. ONE END OF THE PACKAGE IS NOT SEALED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916014 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED. POST-OPERATIVELY, THE PATIENT HAD AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 16468370 ↗
• MalfunctionNov 23, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND AN ABSORBABLE ADHESION BARRIER WAS USED. THE PRODUCT HAD STAINS INSIDE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851977 ↗
• InjuryJun 9, 2022Adverse 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 AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED BENEATH ABDOMINAL WALL. INTRA-ABDOMINAL INFECTION OCCURRED IN ABOUT 7 DAYS AFTER THE SURGERY. THE COLOR OF THE DRAINAGE WHEN INFECTION OCCURRED WAS EVEN MORE BROWNISH THAN USUAL AND CONTAINED SOMETHING LIKE RAGGED SUBSTANCES. THE SURGEON OPINED THAT THERE WAS NO FACTOR THAT COULD BE IDENTIFIED OTHER THAN THE ADHESION PREVENTION MATERIAL. ALTHOUGH THERE IS NO PROBLEM NOW, THE COLOR OF DRAINAGE WAS DARKER THAN USUAL WHEN INFECTION WAS CONFIRMED. THE SYMPTOM IS NOW STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 14649223 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE SEVERAL YEARS AGO AND THE ADHESION BARRIER WAS USED. IT WAS REPORTED THAT THE CASE WAS A SURGERY FOR THE LARGE INTESTINE, BUT THE PROCEDURE NAME WAS UNKNOWN. IT WAS REPORTED THAT AN INTESTINAL OBSTRUCTION HAD OCCURRED AT THE SITE WHERE THE ADHESION BARRIER WAS APPLIED WHEN REOPERATION WAS PERFORMED. IT WAS ALSO REPORTED THAT INFECTION MAY HAVE OCCURRED DUE TO THE ADHESION BARRIER. IT WAS ALSO REPORTED THAT WHEN RE-OPERATION WAS PERFORMED, ADHESION WAS OBSERVED. IT WAS CONSIDERED THAT THE ADHESION BARRIER WAS THE CAUSE OF THE ADHESION. IT WAS ALSO REPORTED THAT SUTURE FAILURE MAY HAVE OCCURRED. IT WAS ALSO REPORTED THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT IS RECOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Adhesion(s); Obstruction/Occlusion; Unspecified Infection

  MAUDE report 13882550 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING A GYNECOLOGICAL PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: 3,359 GYNECOLOGIC (INTERCEED: 2,086; SEPRAFILM: 1,273) PATIENTS HAD PERI-OPERATIVE COMPLICATION AFTER THE PROCEDURE WITH THE USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX HOSPITALIZATION WERE DEFINED WITH THE DIAGNOSIS CODE, ADHESION-RELATED REOPERATION.

  Patient problems: Adhesion(s)

  MAUDE report 13261997 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC DISTAL GASTRECTOMY ON (B)(6) 2021 AND THE ABSORBABLE ADHESION BARRIER WAS USED. IT WAS REPORTED THAT THE ADHESION BARRIER WAS USED JUST BELOW THE ABDOMINAL WALL. IT WAS REPORTED THAT AFTER THE SURGERY THE PATIENT DEVELOPED A LOW-GRADE FEVER. IT WAS REPORTED THAT A CT SCAN WAS PERFORMED THAT REVEALED AN ABSCESS. IT WAS REPORTED THAT AFTER THE SURGERY, THE ABSCESS WAS TREATED WITH PUNCTURE, BUT IT INJURED THE INTESTINE, SO THE PATIENT WAS TREATED BY LAPAROTOMY AND IRRIGATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Fever; Unspecified Tissue Injury

  MAUDE report 12922630 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY ON AN UNKNOWN DATE AND THE ABSORBABLE, ADHESION BARRIER WAS USED. IT WAS REPORTED THAT THE PATIENT DEVELOPED A POSTOPERATIVE ABSCESS AT THE APPLICATION SITE OF THE DEVICE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER THE ABSCESS DEVELOPED, AND THE SYMPTOMS WERE IMPROVED BY ADMINISTERING ANTIBIOTICS FOR THREE DAYS. THE PATIENT'S CONDITION WAS NORMAL THEREAFTER, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess

  MAUDE report 12351227 ↗
• MalfunctionNov 20, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT SUSPECTED PRODUCT WAS NOTED ON (B)(6) 2020 AND WAS RECEIVED FROM AN UNKNOWN SUPPLIER. AFTER COMPARISON WITH AUTHORIZED GOODS, DIFFERENCES WERE IDENTIFIED ON THE LABEL PRINTING, LABEL POSITION, BARCODE AND PRIMARY WRAP. A BLUE NOTE STICK WAS ALSO FOUND ON THE INDIVIDUAL PIECE AS WELL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10878112 ↗
• MalfunctionDec 20, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND THE ABSORBABLE ADHESIVE BARRIER WAS USED. DURING THE SURGERY, BEFORE USED ON THE PATIENT, IT WAS NOTED THE PACKING WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9501671 ↗
• MalfunctionDec 20, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND THE ABSORBABLE ADHESIVE BARRIER WAS USED. DURING THE SURGERY, BEFORE USED ON THE PATIENT, IT WAS NOTED THE PACKING WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9501645 ↗
• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DISTAL GASTRECTOMY PROCEDURE ON UNKNOWN DATE AND THE ABSORBABLE ADHESIVE BARRIER WAS PLACED BETWEEN THE LIVER AND THE STOMACH BEFORE CLOSING THE WOUND. FIVE TO SEVEN DAYS AFTER SURGERY, PAIN OCCURRED IN THE UPPER ABDOMEN AND BLOOD TEST AND CT EXAMINATION SHOWED AN ABSCESS FORMATION WHERE THE ABSORBABLE ADHESIVE BARRIER WAS PLACED. THE ABSCESS WAS REMOVED BY PERFORMING DRAINAGE FOR ABOUT 2 WEEKS. ANTIBIOTICS WERE ADMINISTERED IN ADDITION TO DRAINAGE AS A TREATMENT. CURRENTLY, THERE IS NO PROBLEM WITH THE PATIENT AND NO ADDITIONAL TREATMENT IS PLANNED. THE SURGEON OPINES THAT THE POSSIBLE CAUSE IS A FOREIGN BODY REACTION BY THE ABSORBABLE ADHESIVE BARRIER, BECAUSE THE DRAINAGE OF FLUID WAS MORE BROWN THAN USUAL, AN ABSCESS OCCURRED AT THE SITE WHERE THE DEVICE WAS APPLIED. IT WAS ALSO REPORTED THAT THE PATIENT HAD ALSO DIABETES AND IT IS THOUGHT THAT ABSCESS WAS DUE TO THE PATIENT¿S IMMUNITY DECLINE. HOSPITALIZATION WAS EXTENDED FOR ABOUT TWO WEEKS. THE PATIENT IS CURRENTLY DISCHARGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Abscess; Pain

  MAUDE report 8507321 ↗
• MalfunctionDec 20, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND THE ABSORBABLE ADHESIVE BARRIER WAS USED. THE DEVICE WAS FOUND UNSEALED FOR THE STERILE PACKAGING, AND NO SEALING GLUE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8183348 ↗
• MalfunctionDec 20, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND THE ABSORBABLE ADHESIVE BARRIER WAS USED. THE DEVICE WAS FOUND UNSEALED FOR THE STERILE PACKAGING, AND NO SEALING GLUE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8183337 ↗
• MalfunctionDec 20, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND THE ABSORBABLE ADHESIVE BARRIER WAS USED. THE DEVICE WAS FOUND UNSEALED FOR THE STERILE PACKAGING, AND NO SEALING GLUE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8183326 ↗
• MalfunctionDec 20, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND THE ABSORBABLE ADHESIVE BARRIER WAS USED. THE DEVICE WAS FOUND UNSEALED FOR THE STERILE PACKAGING, AND NO SEALING GLUE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8183309 ↗