Constellation 8065750914Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00380657509140), received between Apr 20, 2022 and Jun 23, 2026 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (10 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THERE WAS NO WATER CAME THROUGH THE TUBING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY HOWEVER THE REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25589376 ↗
• MalfunctionJan 14, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE DEVICE PASSED INSPECTION AND IT WAS DISCOVERED THAT THE TUBE WAS NOT DELIVERING WATER DURING VITRECTOMY SURGERY. THE PRODUCT WAS PROMPTLY REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066264 ↗
• MalfunctionJan 14, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT IT WAS DISCOVERED THAT THE TUBING WAS NOT DELIVERING WATER DURING VITRECTOMY SURGERY. THE PRODUCT WAS PROMPTLY REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065527 ↗
• MalfunctionJan 12, 2026Improper Flow or Infusion

  A PHYSICIAN REPORTED NO WATER CAME THROUGH THE INFUSION TUBING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040153 ↗
• MalfunctionJan 9, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE OUTER PACKAGING REMAINED INTACT, AND THE DEVICE PASSED INSPECTION DURING USE. HOWEVER, DURING THE VITRECTOMY SURGERY, IT WAS DISCOVERED THAT THE TUBE WAS NOT DELIVERING WATER. THE PRODUCT WAS PROMPTLY REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020501 ↗
• MalfunctionJan 7, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT OUTER PACKAGING REMAINED INTACT, AND THE DEVICE PASSED INSPECTION DURING THE USE. HOWEVER, DURING THE VITRECTOMY SURGERY, IT WAS DISCOVERED THAT THE TUBE WAS NOT DELIVERING WATER. THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987755 ↗
• MalfunctionJan 6, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE TUBE WAS NOT DELIVERING WATER DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972944 ↗
• MalfunctionJan 6, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE OUTER PACKAGING REMAINED INTACT, AND THE DEVICE PASSED THE TEST. THE TUBING COULD NOT DELIVER THE WATER DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971357 ↗
• MalfunctionJan 6, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE OUTER PACKAGING WAS INTACT DURING USE AND THE TEST PASSED. THERE WAS NO WATER COMING THROUGH THE TUBING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971298 ↗
• MalfunctionDec 31, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT TUBE WAS NOT DELIVERING WATER DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932284 ↗
• MalfunctionDec 30, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT IT WAS FOUND THAT NO WATER CAME THROUGH THE TUBING DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931192 ↗
• MalfunctionDec 30, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THE FLUID COULD NOT PASS THROUGH THE TUBING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919523 ↗
• MalfunctionDec 30, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THE TUBE WAS NOT DELIVERING WATER DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919497 ↗
• MalfunctionNov 6, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A NURSE REPORTED THAT AUTO INFUSION VALVE COULD NOT RELEASE GAS DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493775 ↗
• MalfunctionAug 20, 2025Air/Gas in Device; Air/Gas in Device

  A NURSE REPORTED THAT PRODUCT LEAKED AIR DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22847797 ↗
• MalfunctionJul 10, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A NURSE REPORTED THAT WHILE USING AIR-FLUID EXCHANGE, THE INFUSION HEAD FAILED TO DELIVER AIR DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472180 ↗
• MalfunctionJun 23, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THE NURSE REPORTED THAT AIR LIQUID EXCHANGE COULD NOT BE OPENED DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307537 ↗
• MalfunctionJun 12, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A NURSE REPORTED AIR AND LIQUID EXCHANGING (NO AIR OUT FROM INFUSION HEAD) DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192329 ↗
• MalfunctionMay 14, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A NURSE REPORTED THAT THE AIR LEAKED DURING FLUID AND AIR EXCHANGE OF VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016833 ↗
• InjuryJan 20, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A PHYSICIAN REPORTED THAT THERE WAS NO GAS FLOW IN THE GAS INFUSION PIPELINE WITH AN AUTOMATIC INFUSION VALVE DURING RETINAL SURGERY. THE PATIENT EXPERIENCED CHOROIDAL HEMORRHAGE. THE PATIENT WAS RECOVERING FROM THE SYMPTOMS. THE INVOLVED EYE WAS UNKNOWN. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE.

  Patient problems: Choroidal Hemorrhage

  MAUDE report 21190520 ↗
• MalfunctionJan 9, 2025No Flow; No Flow

  A NURSE REPORTED THAT NO AIR WAS RELEASED DURING THE GAS-LIQUID EXCHANGE PROCESS OF VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120977 ↗
• MalfunctionDec 12, 2024Blocked Connection; Blocked Connection

  A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE INFUSION TUBING WITH AUTO-INFUSION VALVE WAS NOT UNOBSTRUCTED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 20911136 ↗
• MalfunctionJul 15, 2024Inability to Irrigate; Inability to Irrigate

  A NURSE REPORTED THAT THE TUBING DOES NOT DISCHARGE WATER AFTER CONNECTION BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF NEW PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19737995 ↗
• MalfunctionMay 18, 2024Leak/Splash; Solder Joint Fracture; Leak/Splash; Solder Joint Fracture

  UPON FURTHER REVIEW, REPORTED EVENT GAS-LIQUID EXCHANGE PIPE FELL OFF AND LIQUID LEAKED BEFORE VITRECTOMY SURGERY WITH NO PATIENT HARM IS NOT TO BE CONSIDERED A REPORTABLE MALFUNCTION BECAUSE A SERIOUS INJURY HAS NOT OCCURRED AND IT IS NOT LIKELY THAT A RECURRENCE WOULD RESULT IN SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347959 ↗
• MalfunctionMay 8, 2024Break; Solder Joint Fracture; Break; Solder Joint Fracture

  A SURGEON REPORTED THAT INTERFACE OF THE TUBE BROKE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266118 ↗