SEPRAMESH 5959124Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741031793), received between Dec 11, 2017 and Feb 18, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012: PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND DISSECTED AWAY FROM SURROUNDING TISSUES. THE HERNIATED CONTENTS WERE PERITONEAL FAT WAS DISSECTED AWAY AND REMOVED. ALL THE ADHESIONS WERE CLEARED. A SEPRAMESH IP (DEVICE 1) WAS TRIMMED AND PLACED IN THE DEFECT AND SEWN USING SUTURES.¿ (B)(6) 2012: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 2). PER OP NOTES, ¿THE FASCIAL DEFECTS IN THE MIDDLE OF THE ABDOMEN ABOVE AND BELOW THE PREVIOUS REPAIR. THE PREVIOUS MESH WAS INTACT. SEVERAL ADHESIONS OF THE OMENTUM TO ABDOMINAL WALL WERE LYSED. THE MULTIPLE DEFECTS WERE NOTED AND REDUCED. A SEPRAMESH IP (DEVICE 2) WAS TRIMMED AND PLACED TO COVER ALL THE DEFECTS AND SECURED USING SUTURES. THE MESH WAS TACKED USING FIXATION DEVICE.¿ (B)(6): PATIENT WAS DIAGNOSED WITH RECURRENT MULTIPLE INCISIONAL OR VENTRAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF SEPRAMESH IP (DEVICE 1 AND 2) AND IMPLANT OF SEPRAMESH IP (DEVICE 3 AND 4). PER OP NOTES, ¿TW

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24379420 ↗
• InjuryMar 5, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SEPRAMESH COMPOSITE IP ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH COMPOSITE IP. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Adhesion(s); Disability; Fistula; Injury; Pain; Unspecified Infection

  MAUDE report 9792016 ↗
• InjuryNov 20, 2019Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Migration; Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SEPRAMESH IP ON (B)(6) 2015. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL SEPRAMESH IP. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Injury; Unspecified Infection

  MAUDE report 9348588 ↗
• InjuryFeb 22, 2019Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2011: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SEPRAMESH IP. NI/NI/NI: THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL SEPRAMESH IP. THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Fistula; Hernia; Injury; Obstruction/Occlusion; Strangulation

  MAUDE report 8363978 ↗
• MalfunctionNov 19, 2018Use of Device Problem; Expiration Date Error; Use of Device Problem; Expiration Date Error

  IT WAS REPORTED THAT ON (B)(6) 2018 AN EXPIRED (EXPIRATION 09/28/2018) SEPRAMESH WAS IMPLANTED INTO THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED, NOR WAS THERE ANY REPORTED MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085883 ↗
• InjurySep 6, 2018Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2010: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SEPRAMESH IP. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH IP. THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT."

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 7851465 ↗
• InjuryMar 30, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2010 - THE PATIENT UNDERWENT SURGERY WITH IMPLANT OF AN UNSPECIFIED BARD/DAVOL SEPRAMESH IP. ON "NI/NI/NI" - THE PATIENT HAD UNSPECIFIED INJURIES. AS REPORTED, THE PATIENT'S ATTORNEY ALLEGES A GENERAL CLAIM "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED".

  Patient problems: Adhesion(s); Disability; Erosion; Fistula; Hernia; Impaired Healing; Injury; Pain; Unspecified Infection

  MAUDE report 7386136 ↗
• InjuryDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT IN (B)(6) 2015 THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL TUMOR; RESECTION OF THE ABDOMINAL WALL, BLADDER AND SMALL INTESTINE WAS PERFORMED. THE SURGEON THEN IMPLANTED A BARD SEPRAMESH IP "AS A BRIDGE" AND THEN CLOSED THE ABDOMEN. SUBSEQUENTLY, 4-5 MONTHS POST-OP, THE PATIENT PRESENTED WITH A SMALL HOLE (WOUND DEHISCENCE) WITH DRAINAGE OF FECES, AT THE HEIGHT OF THE LOWER THIRD OF THE INCISION. THE SURGEON PERFORMED AN EXPECTANT TREATMENT, HOWEVER THE HOLE (WOUND DEHISCENCE) HAD GROWN, THE FECES DRAINAGE CONTINUED AND MESH WAS EXPOSED. THEREFORE ON (B)(6) 2017 THE PATIENT UNDERWENT A PROCEDURE TO REMOVED THE MESH AND ADVANCED A TREATMENT WITH A VACUUM SYSTEM FOR DRAINAGE. CURRENTLY, THE PATIENT IS BEING MONITORED TO DETERMINE IF FURTHER TREATMENT IS REQUIRED.

  Patient problems: Wound Dehiscence

  MAUDE report 7106340 ↗