Phasix 1210011Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741161216), received between Jan 24, 2025 and Mar 31, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE WHEN REMOVING THE PHASIX ST W/ ECHO 2 FROM THE PACKAGING, THE ECHO 2 FRAME WAS DETACHED FROM THE MESH. THE PRODUCT WAS DISCARDED AND A VENTRALIGHT ST MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741653 ↗
• MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A LAPAROSCOPIC VENTRAL HERNIA REPAIR WAS PERFORMED ON (B)(6) 2025. DURING THIS PROCEDURE, IT WAS REPORTED THAT THE ECHO 2 DETACHED FROM THE PHASIX ST MESH. THE DETACHMENT OCCURRED WHEN THE SURGEON INSERTED THE MESH INTO THE 12 MM TROCAR, AND WHEN IT WAS GRASPED TO PULL IT THROUGH ONLY THE ECHO 2 WAS GRASPED NOT THE MESH. A NEW PHASIX ST W/ ECHO 2 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826300 ↗
• MalfunctionNov 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED 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 MESH W/ ECHO 2 FROM LOT NUMBER HUKS0042 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647378 ↗
• MalfunctionNov 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED ON 05-NOV-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 MESH W/ ECHO 2 FROM LOT NUMBER HUKS0032 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647346 ↗
• MalfunctionNov 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED 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 MESH W/ ECHO 2 FROM LOT NUMBER HUKQ1469 OPENED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647343 ↗
• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, SURGEON WAS TRIED TO IMPLANT THE PHASIX ST W/ ECHO 2 PS MESH USING 12 MM TROCAR. IT WAS REPORTED THAT THE POSITIONING DEVICE CAME OFF AS IT WAS BEING INSERTED INTO THE TROCAR AND THE SURGEON USED ANOTHER PHASIX ST W/ ECHO 2 DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228259 ↗