Phasix 1221520Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741163210), received between Nov 24, 2025 and Nov 24, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ON (B)(6) 2025 DURING TWO SEPARATE CASES FOR HIATAL HERNIA REPAIR, THE USER FACILITY REPORTS THAT THE FOIL POUCHES ONCE OPENED HAD PIN HOLES ALONG WITH DEEP SCRATCHES AND ARE CONCERNED THEY HAVE BEEN COMPROMISED. BREACH OF STERILITY. THEY ALLEGED THEY CAN SEE LIGHT THROUGH THE POUCH WHEN USING A FLASHLIGHT DURING INSPECTION. THE FACILITY PERFORMED AN INVENTORY INSPECTION OPENING MULTIPLE PRODUCTS (PHASIX ST, VENTRALIGHT ST, PHASIX OPS, PHASIX ECHO) WITH THE SAME CONDITION OF DAMAGE. THE TWO CASES WERE COMPLETED USING ANOTHER DEVICE THAT DID NOT EXHIBIT THE SAME ISSUE. THIS RESULTED IN AN INCONSEQUENTIAL DELAY. THERE WAS NO PATIENT HARM AS A RESULT OF THE PROBLEM EXPERIENCED. THIS MDR REPRESENTS THE 1 PHASIX ST W/ OPS FROM LOT NUMBER HUJP1056 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632021 ↗