Phasix 1192030Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741107627), received between Sep 1, 2021 and May 8, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND UNDERWENT AN OPEN PRIMARY LAPAROTOMY, EXPLORATORY LAPAROTOMY AND COLECTOMY DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT SUTURES WITH 2-0 PDS. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH (30 CM LENGTH AND 7 CM WIDTH). THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBING MONOFILAMENT WITH RUNNING STITCHES APPROXIMATELY 1 CM FAR APART AND 63 CM IN LENGTH. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED A SEROMA ON INCISION SITE, NO TREATMENT OR MEDICATION REQUIRED. THE SEROMA IS REPORTED AS RECOVERING AND RESOLVING. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND A PROBABLE RELATIONSHIP TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY AND RECOVERING AND RESOLVING; THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

  Patient problems: Seroma

  MAUDE report 25123101 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  AS REPORTED PER THE CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND UNDERWENT EXPLORATORY LAPAROTOMY FOR A COLOSTOMY AND LYSIS OF ADHESIONS DURING WHICH A PHASIX FLAT MESH WAS PLACED IN AN ONLAY FASHION AND SECURED USING ABSORBABLE MONOFILAMENT SUTURES AND CONCURRENTLY UNDERWENT AN OSTOMY/FISTULA TAKEDOWN. ERTAPENEM WAS ADMINISTERED PRIOR TO THE SURGERY AS A PROPHYLACTIC ANTIBIOTIC. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT CONTINUED SEROSANGUINOUS DRAINAGE. ON (B)(6) 2026, THE PATIENT WAS DIAGNOSED WITH BULGING AND FLUCTUANCE ALONG THE INCISION LINE BELOW THE UMBILICUS, WITH ASSOCIATED SKIN REDNESS. A CT SCAN OF THE ABDOMEN AND PELVIS REVEALED TWO FLUID COLLECTIONS: A LARGE SUBCUTANEOUS COLLECTION MEASURING 5.5 × 3.6 × 13.5 CM WITH INTERNAL FAT, AND A SMALLER 2.0 × 2.6 CM COLLECTION THAT COMMUNICATES WITH THE SKIN. AN INTERVENTIONAL RADIOLOGY DRAIN WAS PLACED, WITH 80 ML OF FLUID OUTPUT. CULTURE RESULTS FROM THE ABDOMINAL WOUND OPENING SHOWED RARE STAPHYLOCOCCUS LUGDUNENSIS. CULTURE FROM THE ABDOMINAL FLUID COLLECTION GREW FEW PROPIONIBACTERIUM (CUTIBACTERIUM) AVIDUM. THE PATIENT WAS TREATED

  Patient problems: Bacterial Infection; Seroma

  MAUDE report 24700329 ↗
• InjuryFeb 3, 2026Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND UNDERWENT AN OPEN RELAPAROTOMY COLECTOMY AND LYSIS OF ADHESION DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MULTIFILAMENT SUTURES WITH 2-0 PDS. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED PROLONGED ILEUS. PATIENT RECEIVED A PICC LINE TO INITIATE TOTAL PARENTERAL NUTRITION. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE REPORTED ADVERSE EVENT (PROLONGED ILEUS) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY; THE REPORTED AE MEETS THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

  Patient problems: Obstruction/Occlusion

  MAUDE report 24245675 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED PER PREVENT CLINICAL TRIAL DVL-HE-018: ON (B)(6) 2021, THE PATIENT UNDERWENT AN OPEN EXPLORATORY LAPAROTOMY FOR PERFORATION REPAIR WITH LYSIS OF ADHESIONS WITH IMPLANT OF A BARD/DAVOL PHASIX MESH IN AN ONLAY FASHION IN A CLASS III (CONTAMINATED) WOUND. THE MESH WAS TRIMMED AND ADEQUATE OVERLAP OF THE DEFECT WAS ACHIEVED. SKIN INCISIONS WERE MADE STRAIGHT, MIDLINE. THE MESH WAS SECURED USING SUTURES AND FASCIAL CLOSURE WAS MADE WITH NON-BARD/DAVOL SUTURES IN A RUNNING STITCH TECHNIQUE. OVERNIGHT, THE PATIENT DEVELOPED HYPOTENSION, RESPIRATORY INSUFFICIENCY AND BILE DRAINAGE FROM BLAKE DRAINS AND UNDERWENT AN EXPLORATORY LAPAROTOMY ON (B)(6) 2021. A LEAK WAS NOTED AT THE DUODENOJEJUNOSTOMY, LIKELY SECONDARY TO A HISTORY OF NECROTIZING PANCREATITIS AND PORTAL VEIN THROMBOSIS. AS REPORTED, THE SURGEON TOOK DOWN THE ANASTOMOSIS, PLACED A DUODENAL T-TUBE, PERFORMED STAPLED PYLORIC EXCLUSION, GASTROJEJUNOSTOMY AND PLACEMENT OF BALLOON GASTROJEJUNOSTOMY FEEDING TUBE. A NON-BARD/DAVOL DEVICE WAS PLACED FOR TEMPORARY ABDOMINAL WALL CLOSURE. AS REPORTED, THE PHASIX MESH WAS REMOVED IN ORDER TO ENTER THE ABDOMEN FOR THE LAPAROTOMY. AS REPORTED, THE PATIENT HAD RECOVERED FROM THE AC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414627 ↗
• InjurySep 1, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  AS REPORTED PER PREVENT CLINICAL TRIAL DVL-HE-018: ON (B)(6) 2021, THE PATIENT UNDERWENT AN OPEN PANCREATICODUODENECTOMY AND IMPLANT OF A BARD/DAVOL PHASIX MESH IN AN ONLAY FASHION. THE MESH WAS TRIMMED AND ADEQUATE OVERLAP OF THE DEFECT WAS ACHIEVED. SKIN INCISIONS WERE MADE STRAIGHT, MIDLINE. NON-BARD/DAVOL MECHANICAL FIXATION WAS USED TO SECURE THE MESH. A FASCIAL CLOSURE WAS MADE WITH NON-BARD/DAVOL SUTURE IN A RUNNING STITCH TECHNIQUE. AS REPORTED, THE SUBJECT PATIENT EXPERIENCED A POSTOPERATIVE HEMORRHAGE ON (B)(6) 2021, WAS TAKEN BACK INTO THE OPERATING ROOM. THE PREVIOUS INCISION WAS OPENED AND THE MESH WAS REMOVED. AS REPORTED, THE MESH NEEDED TO BE REMOVED TO ACCESS THE HEMORRHAGE, NOT BECAUSE OF A MALFUNCTION WITH THE MESH. THIS ADVERSE EVENT HAS BEEN ASSESSED AS NOT RELATED TO THE PHASIX MESH AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Wound Dehiscence

  MAUDE report 12408216 ↗