Kiwi® Omni-C Cup® VAC-6000CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814247020628), received between Jul 21, 2022 and Jun 23, 2023 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K981260); they may or may not involve this specific model.

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.

• DeathJun 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IN THE CUSTOMERS WORDS: TODAY I WAS INFORMED ABOUT THE INCIDENT BY MR. (B)(6) (SPECIALIST MATERIOVIGILANCE MEDICAL DEVICES). AN INCIDENT OCCURRED IN (B)(6) CLINIC IN (B)(6) ON (B)(6) 2023. THE KIWI SLIPPED TWICE AND FAILED TO BUILD A VACUUM. SINCE THE CHILD PASSED AWAY, THE QUESTION ARISES WHETHER THIS DELAY HAS AN INFLUENCE ON IT. THE REPORT WAS MADE TO SWISSMEDIC ON MAY 15, 2023. FOLLOW UP QUESTION RESPONSES: IS THE DEVICE AVAILABLE TO BE SENT BACK FOR EVALUATION? WHEN YOU STATE THE "KIWI SLIPPED", DOES THIS MEAN THE DEVICE CUP POPPED OFF OF THE INFANT'S HEAD AFTER TRACTION/PULLING FORCE WAS INITIATED? WHAT TIME WAS THE VACUUM APPLIED TO THE BABY'S HEAD? WHAT TIME WERE EACH OF THE "SLIPS" DOCUMENTED? WHAT TIME WAS THE CUP REMOVED? TOTAL TIME THE VACUUM WAS APPLIED? AND WHAT TIME WAS THE BABY DELIVERED? WHERE WAS THE CUP PLACE ON THE BABY'S HEAD? WAS IT PLACED ON THE FLEXION POINT? WAS THE BABY DELIVERED VAGINALLY BY ANY OTHER METHOD (FORCEPS) OR BY C-SECTION? HAD THE PHYSICIAN BEEN TRAINED ON HOW TO USE THE KIWI DEVICE? WERE THE KIWI IFU'S FOLLOWED? WAS THE SUCTION CHECKED PRIOR TO USING ON THE PHYSICIAN'S GLOVED HAND? WHAT WAS THE ESTIMATED FETAL WEIGHT OF INFANT? HOW MANY WEEKS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17193519 ↗
• InjuryJul 21, 2022Detachment of Device or Device Component

  IN THE CUSTOMERS WORDS: "THE KIWI WAS USED DURING A C-SECTION. AFTER DELIVERY A SMALL WHITE PIECE OF PLASTIC WAS FOUND IN ABDOMINAL CAVITY WHILE CLOSING THE UTERUS. WE WERE UNSURE OF THE ORIGIN OF THE PLASTIC. AFTER PATIENT LEFT THE OR WE DISCOVERED THAT THE PIECE CAME FROM THE HANDLE OF THE KIWI. I CALLED THE COMPANY TO REPORT INCIDENT. IT WAS THEN THAT WE FOUND THAT THERE ARE TWO PIECES THAT SHOULD HAVE BEEN RETRIEVED. THE SILICONE DISC THAT IS UNDER THE PIECE OF PLASTIC WAS NOT SEEN. THE KIWI THAT WAS USED WAS REMOVED FROM THE TRASH AND WAS FOUND TO BE MISSING BOTH PIECES."

  Patient problems: Foreign Body In Patient

  MAUDE report 15075642 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981260. One submission often covers many models, so check the product and lot details in each record.

• Z-1945-2026 · Mar 9, 2026 · Open, Classified
  Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is
• Z-2072-2020 · Aug 6, 2019 · Terminated
  Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.