Gentrix® MSPL1015Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00386190001240), received between May 8, 2018 and Jun 14, 2019 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2019, ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING A HERNIA REPAIR. THE DEVICE WAS NOT USED. THE SURGEON DECIDED TO USE A DEVICE FROM ANOTHER MANUFACTURER. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH NOR THE INCREASED SURGERY TIME.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8701269 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, ACELL, INC. WAS NOTIFIED BY A SURGEON THAT A PATIENT HAD A FASCIAL DEHISCENCE WITH BOWEL OBSTRUCTION REQUIRING EMERGENT SURGERY AND HOSPITALIZATION ON (B)(6) 2019. THE SURGEON OBSERVED THAT THE PRIMARY SUTURES USED TO CLOSE THE DEFECT HAD RUPTURED ALONG WITH THE IMPLANTED ACELL DEVICE WHICH HAD BEEN PLACED AS AN UNDERLAY. THE SURGEON INFORMED ACELL THAT THE PATIENT HAD BEEN NON-COMPLAINT WITH POST-OPERATIVE ACTIVITY INSTRUCTIONS. THE SURGEON EXPLANTED AND DISCARDED THE ACELL DEVICE. THE SUBSEQUENT REPAIR WAS COMPLETED WITH A NON-ACELL DEVICE, A SYNTHETIC MESH. THERE WAS NO INFECTION PRESENT AFTER ACELL IMPLANTATION OR AT ACELL EXPLANTATION. THE PATIENT DEVELOPED AN INFECTION AFTER IMPLANTATION OF THE SYNTHETIC MESH.

  Patient problems: Obstruction/Occlusion; Wound Dehiscence

  MAUDE report 8405977 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 1/3/2019, ACELL, INC. WAS NOTIFIED BY A PHYSICIAN THAT THEIR PATIENT DEVELOPED AN INFECTION AFTER APPLICATION OF AN ACELL DEVICE AND USAGE OF KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM. THE SURGEON CONDUCTED A COLOSTOMY REVERSAL AND PARASTOMAL HERNIA REPAIR ON (B)(6) 2018, AN ACELL DEVICE WAS PLACED IN AN UNDERLAY TECHNIQUE AND THE FASCIA RE-APPROXIMATED. THE SKIN WAS LEFT OPEN WITH KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM APPLIED TO THE AREA. DURING THE FIRST WOUND VACUUM CHANGE, AN INFECTION WAS DISCOVERED. THE SURGEON IS UNSURE IF THE DEVICE WAS THE CAUSE THE INFECTION. THE SURGEON PERFORMED A POST-OPERATIVE WASHOUT AND DEBRIDEMENT INCLUDING THE EXPLANTING OF THE ACELL DEVICE. THERE WAS NO DATE PROVIDED OF WHEN THIS PROCEDURE WAS CONDUCTED.

  Patient problems: Unspecified Infection

  MAUDE report 8297540 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 4/16/2018 ACELL RECEIVED NOTIFICATION FROM PHYSICIAN REGARDING A PATIENT WHO EXPERIENCED POST OPERATIVE FLUID DRAINAGE AFTER TREATMENT WITH AN ACELL DEVICE. PATIENT HAD EPIGASTRIC HERNIA 12 CM IN LENGTH WHICH WAS REPAIRED WITH AN ACELL SURGICAL GRAFT ON (B)(6) 2018. PATIENT HAS HAD FLUID ACCUMULATING IN HER SUBCUTANEOUS SPACE WHICH HAS REQUIRED FLUID DRAINAGE EVACUATED 6 TO 8 WEEKS POST OPERATIVE.

  Patient problems: Seroma

  MAUDE report 7537892 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 ACELL RECEIVED NOTIFICATION FROM PHYSICIAN REGARDING A PATIENT WHO EXPERIENCED POST OPERATIVE FLUID DRAINAGE AFTER TREATMENT WITH AN ACELL DEVICE. PATIENT HAD EPIGASTRIC HERNIA 12 CM IN LENGTH WHICH WAS REPAIRED WITH AN ACELL SURGICAL GRAFT ON (B)(6) 2018. PATIENT HAS HAD FLUID ACCUMULATING IN HER SUBCUTANEOUS SPACE WHICH HAS REQUIRED FLUID DRAINAGE EVACUATED 6 TO 8 WEEKS POST OPERATIVE.

  Patient problems: Seroma

  MAUDE report 7537891 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A VENTRAL HERNIA REPAIR SURGERY CONDUCTED ON (B)(6) 2017. AN EXPLORATORY LAPORATOMY ON (B)(6) 2017 REVEALED THE PATIENT HAD MULTIPLE ADHESIONS AND MULTIPLE LOOPS OF SMALL BOWEL STUCK TOGETHER WITH AN ACELL SURGICAL SHEET. THE ADHESIONS WERE REMOVED, THE BOWEL RESECTED AND THE ACELL SURGICAL SHEET WAS PARTIALLY EXPLANTED. HOSPITAL PATHOLOGY RESULTS INDICATED THE PRESENCE OF ADENOCARCINOMA IN MESENTERIC TISSUE A FOLLOW UP CT DISCOVERED DIFFUSE ADENOCARCINOMA THROUGHOUT THE BOWEL. THE SURGEON AT THE TIME BELIEVED THAT THE COMPLICATIONS WERE DUE TO THE SPREAD OF CANCER POST-OPERATIVELY, NOT DUE TO THE ACELL SURGICAL SHEET. ON 4/10/2018 ACELL RECEIVED NOTIFICATION DURING A FOLLOW-UP CALL BETWEEN CHIEF SCIENCE OFFICER AND SURGEON, IT WAS DISCOVERED THAT PATIENT DEVELOPED A SEROMA POST OPERATIVE WHICH WAS DRAINED PERCUTANEOUSLY. ADDITIONALLY, IT WAS THE SURGEON'S OPINION THE DIFFUSE CANCER WAS THE PRIMARY REASON FOR ADHESION FORMATION. THE DEVELOPMENT OF ADHESIONS TO THE SURGICAL CLOSURE, WHICH INCLUDED AN ACELL SURGICAL SHEET, MAY HAVE LED TO THE DEVELOPMENT OF THE BOWEL OBSTRUCTION DISCOVERED ON (B)(6) 2017, WHICH NECESSITATED OPERATIVE INTERVENTION. IT WAS THIS CLARIFICATIO

  Patient problems: Adhesion(s); Obstruction/Occlusion; Seroma

  MAUDE report 7494927 ↗