BIASURGE™ Advanced Surgical Solution BAS-0101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850017274006), received between Sep 30, 2026 and Sep 30, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient Device Interaction Problem

  On (b)(6) 2026, BIASURGE Advanced Surgical Irrigation Solution was used at the end of an abdominal procedure for a large ventral hernia repair at Ochsner Medical Center. The patient was a 37 year-old female without significant co-morbidities. BIASURGE was used as a warmed fluid instilled after decanted to the large surgical surface area superficial to the peritoneal cavity. The patient developed a significant rash after use of BIASURGE and became hypotensive and tachycardic. Medical intervention included administration of Benadryl and steroids, after which the patient's condition returned to baseline over four hours without any permanent effects.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50944876 ↗
• InjurySep 30, 2026Patient Device Interaction Problem

  On (b)(6)2026, BIASURGE Advanced Surgical Irrigation Solution was used at the end of an abdominal procedure within the peritoneal cavity at (b)(6) . The patient was an 18 year-old female with no known co-morbidities. The procedure was a revision of an anastomotic stricture from an appendectomy done one month prior to this case. The surgeon determined there was some abdominal contamination during the repair. At the completion of the robotic procedure, warmed BIASURGE was instilled into the abdominal cavity, and a small portion was not suctioned out of the cavity. The surgeon withdrew the instrumentation and went to proceed with the closure steps. Following the peritoneal cavity irrigation with BIASURGE the patient's blood pressure dropped requiring re-intubation and pressor support. The patient was checked for internal bleeding and none was found. After the case the patient was transferred to the ICU intubated due to instability. There was no permanent injury to the patient.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50944875 ↗