SEPRAFILM 430102Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05413765589614), received between Jul 1, 2026 and Jul 1, 2026 — classified as 1 injury.

5 other recalls cover devices cleared under the same FDA submission (P950034); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO (2) SEPRAFILM ADHESION BARRIERS WERE USED DURING A PARTIAL PELVIC PERITONECTOMY. THE PATIENT, WITH A MEDICAL HISTORY INCLUDING ADENOMYOSIS, BILATERAL OVARIAN CHOCOLATE CYSTS, AND SEVERE PELVIC ENDOMETRIOSIS ADHESIONS, UNDERWENT A SINGLE-PORT ROBOTIC HYSTERECTOMY WITH BILATERAL OVARIAN TUMOR RESECTION AND PELVIC ENDOMETRIOSIS RESECTION. DURING PARTIAL PELVIC PERITONEECTOMY, TWO SEPRAFILM SHEETS WERE USED TO COMPLETELY ADHERE TO THE PELVIC FLOOR. THE INCISIONS AFTER PERITONEAL REMOVAL, THE SUPERFICIAL LAYER OF THE RIGHT URETER, AND THE VAGINAL INCISION AFTER UTERINE REMOVAL WERE ALSO ADDRESSED. CONSIDERING THE SINGLE-PORT SURGERY AND INTRAOPERATIVE BLOOD LOSS OF LESS THAN 100 ML, NO DRAINAGE TUBE WAS PLACED. THE PATIENT DEVELOPED FEVER, NAUSEA, VOMITING, AND ABDOMINAL DISTENSION ON THE SECOND POSTOPERATIVE DAY. A CT SCAN REVEALED PARALYTIC ILEUS, AND APPROXIMATELY 150 ML OF FLUID WAS FOUND IN THE PELVIC FLOOR. BLOOD TESTS SHOWED WBC: 15000, SEGMENTED ECLAMPSIA: 80, CRP: 169. THEREFORE, THE PATIENT RECEIVED CONTINUOUS ANTIBIOTIC AND ANTI-INFLAMMATORY MEDICATION FOR CONTROL. BY THE 14TH DAY POST SURGERY, THE PATIENT WAS ABLE TO EAT AND DEFECATE NORMALLY BUT CON

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25682160 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950034. One submission often covers many models, so check the product and lot details in each record.

• Z-1689-2024 · Mar 15, 2024 · Open, Classified
  Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
• Z-1855-2012 · Jun 13, 2012 · Terminated
  seprafilm Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic lapar
• Z-1856-2012 · Jun 13, 2012 · Terminated
  seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotom
• Z-1647-2008 · Apr 10, 2008 · Terminated
  Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier) Product Number: 4301-02
• Z-1648-2008 · Apr 10, 2008 · Terminated
  Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only Product Number: 4301-05