Kiwi® ProCup® VAC-6000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814247020666), received between Nov 18, 2019 and Apr 19, 2022 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionApr 19, 2022Suction Failure

  MD USED KIWI TO ASSIST WITH A CESAREAN OF AN IUFD. WHEN SHE ATTEMPTED TO USE THE PALM PUMP FOR THE VACUUM, THERE WAS NO SUCTION PRODUCED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160999 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIRST TIME MOM SPONTANEOUS LABOR. NO INDICATION LISTED IN DELIVERY NOTE FOR VACUUM DELIVERY, BUT BABY WAS REPORTED TO HAVE A NON-REASSURING FETAL HEART RATE TRACING. NO MENTION OF POSITION OR STATION AT THE TIME OF DELIVERY. EXPERIENCED CLINICIAN, BUT NOT WITH KIWI. PROCUP WAS USED, UNKNOWN LOT NUMBER (CUP WAS NOT RETAINED). NO MENTION OF PULLS OR POP-OFFS IN DELIVERY CHART BUT WAS REPORTED TO BE AN "EASY DELIVERY". AGAIN 2ND DAY NOTED INCREASED HEAD SWELLING. CT SHOWED SUBGALEAL HEMORRHAGE. BABY TRANSFERRED TO NICU AND STABILIZED. IS DOING WELL WITHOUT SEQUELAE AND WILL BE DISCHARGED TOMORROW.

  Patient problems: Hemorrhage, Subgaleal

  MAUDE report 9335765 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIRST TIME MOM INDUCED AT 37 WEEKS AND 2 DAYS. NO INDICATION LISTED IN CHART FOR VACUUM DELIVERY, BUT SHERRY WAS TOLD THAT THE BABY'S HEART RATE DROPPED, AND THEY WERE TRYING TO HURRY WITH THE DELIVERY. VERY EXPERIENCED CLINICIAN WITH KIWI. PROCUP USED, UNKNOWN LOT NUMBER (CUP WAS NOT RETAINED). NO MENTION OF POSITION OR STATION AT TIME OF CUP APPLICATION BUT WAS REPORTED TO BE "HIGH". BABY DELIVERED WITH ONE PULL, NO POP-OFFS, VERY LITTLE EFFORT REQUIRED. SECOND DAY OF LIFE NURSERY NOTED HEAD SWELLING AND HEMATOCRIT DROP. CT SHOWED A SUBGALEAL HEMORRHAGE. BABY WAS TRANSFERRED TO NICU AND STABILIZED. DISCHARGED HOME WITHOUT SEQUELAE SEVERAL DAYS LATER.

  Patient problems: Hemorrhage, Subgaleal

  MAUDE report 9335763 ↗

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.