Kiwi® OmniCup® VAC-6000MRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00814247020000), received between Dec 5, 2018 and Feb 1, 2024 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IN CUSTOMER WORDS: "HELLO, WE HAVE A CUSTOMER THAT HAS CALLED ME ABOUT SOME ISSUES WHILE USING THE KIWI. THEY ARE LONG TIME USERS OF THE PRODUCT. THEY RECENTLY HAVE HAD THREE BABIES THAT HAVE HAD LACERATIONS ON THE SCALP CAUSED BY POP OFFS. THIS SEEMS MOST LIKELY CAUSED BY PROVIDER NOT FOLLOWING THE VACCA 5 STEP PROCESS. WE ARE WORKING ON SETTING DATES FOR A EDUCATION WORKSHOP FOR THE STAFF. WE HOPE TO HAVE THAT COMPLETED IN THE NEXT FEW WEEKS. MY QUESTION IS, SHOULD I FILL OUT A COMPLAINT FORM? I HAVE THE LOT NUMBER, BUT THEY DISCARDED THE KIWI (S) THAT WERE INVOLVED IN THE DELIVERIES." "DR USED KIWI FOR AN OPERATIVE DELIVERY. DR EXPERIENCED A POP-OFF AND THE RESULT OF THE POP-OFF WAS A LACERATION TO THE INFANT SCALP. THIS HAPPENED ON THREE DIFFERENT OCCASIONS WITH THREE DIFFERENT KIWIS ALL FROM THE SAME LOT NUMBER."

  Patient problems: Laceration(s)

  MAUDE report 18624557 ↗
• InjuryFeb 1, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IN CUSTOMER WORDS: "HELLO, WE HAVE A CUSTOMER THAT HAS CALLED ME ABOUT SOME ISSUES WHILE USING THE KIWI. THEY ARE LONG TIME USERS OF THE PRODUCT. THEY RECENTLY HAVE HAD THREE BABIES THAT HAVE HAD LACERATIONS ON THE SCALP CAUSED BY POP OFFS. THIS SEEMS MOST LIKELY CAUSED BY PROVIDER NOT FOLLOWING THE VACCA 5 STEP PROCESS. WE ARE WORKING ON SETTING DATES FOR A EDUCATION WORKSHOP FOR THE STAFF. WE HOPE TO HAVE THAT COMPLETED IN THE NEXT FEW WEEKS. MY QUESTION IS, SHOULD I FILL OUT A COMPLAINT FORM? I HAVE THE LOT NUMBER, BUT THEY DISCARDED THE KIWI (S) THAT WERE INVOLVED IN THE DELIVERIES." "DR USED KIWI FOR AN OPERATIVE DELIVERY. DR EXPERIENCED A POP-OFF AND THE RESULT OF THE POP-OFF WAS A LACERATION TO THE INFANT SCALP. THIS HAPPENED ON THREE DIFFERENT OCCASIONS WITH THREE DIFFERENT KIWIS ALL FROM THE SAME LOT NUMBER."

  Patient problems: Laceration(s)

  MAUDE report 18624543 ↗
• InjuryFeb 1, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IN CUSTOMER WORDS: "HELLO, WE HAVE A CUSTOMER THAT HAS CALLED ME ABOUT SOME ISSUES WHILE USING THE KIWI. THEY ARE LONG TIME USERS OF THE PRODUCT. THEY RECENTLY HAVE HAD THREE BABIES THAT HAVE HAD LACERATIONS ON THE SCALP CAUSED BY POP OFFS. THIS SEEMS MOST LIKELY CAUSED BY PROVIDER NOT FOLLOWING THE VACCA 5 STEP PROCESS. WE ARE WORKING ON SETTING DATES FOR A EDUCATION WORKSHOP FOR THE STAFF. WE HOPE TO HAVE THAT COMPLETED IN THE NEXT FEW WEEKS. MY QUESTION IS, SHOULD I FILL OUT A COMPLAINT FORM? I HAVE THE LOT NUMBER, BUT THEY DISCARDED THE KIWI (S) THAT WERE INVOLVED IN THE DELIVERIES." "DR USED KIWI FOR AN OPERATIVE DELIVERY. DR EXPERIENCED A POP-OFF AND THE RESULT OF THE POP-OFF WAS A LACERATION TO THE INFANT SCALP. THIS HAPPENED ON THREE DIFFERENT OCCASIONS WITH THREE DIFFERENT KIWIS ALL FROM THE SAME LOT NUMBER."

  Patient problems: Laceration(s)

  MAUDE report 18624342 ↗
• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IN THE CUSTOMER WORDS: "THE PHYSICIAN WAS ATTEMPTING TO CARRY OUT A VACUUM DELIVERY OF A BABY . THE KIWI OMNI CUP, FAILED TO MAINTAIN PRESSURE. PHYSICIAN USED THREE ( TWO OF ONE LOT AND ONE OF ANOTHER), ALL GIVING SAME MALFUNCTION. ONCE THE DEVICE WAS PUMPED UP TO A PRESSURE, THE PRESSURE GAUGE RELEASED AND THERE WAS A LOSS OF PRESSURE, CAUSING THE TRACTION TO BE INEFFECTIVE IN HELPING BABY'S BIRTH. DEVICE HAS BEEN REPLACED WITH NEW LOT NUMBERED DEVICES. MOM WAS STABLE BUT BABY APGAR 2 AND BABY NEEDED RESUS."

  Patient problems: Insufficient Information

  MAUDE report 16856926 ↗
• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IN THE CUSTOMER WORDS: "THE PHYSICIAN WAS ATTEMPTING TO CARRY OUT A VACUUM DELIVERY OF A BABY. THE KIWI OMNI CUP, FAILED TO MAINTAIN PRESSURE. PHYSICIAN USED THREE ( TWO OF ONE LOT AND ONE OF ANOTHER), ALL GIVING SAME MALFUNCTION. ONCE THE DEVICE WAS PUMPED UP TO A PRESSURE, THE PRESSURE GAUGE RELEASED AND THERE WAS A LOSS OF PRESSURE, CAUSING THE TRACTION TO BE INEFFECTIVE IN HELPING BABY'S BIRTH. DEVICE HAS BEEN REPLACED WITH NEW LOT NUMBERED DEVICES. MOM WAS STABLE BUT BABY APGAR 2 AND BABY NEEDED RESUS."

  Patient problems: Insufficient Information

  MAUDE report 16854921 ↗
• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IN THE CUSTOMER WORDS: "THE PHYSICIAN WAS ATTEMPTING TO CARRY OUT A VACUUM DELIVERY OF A BABY . THE KIWI OMNI CUP, FAILED TO MAINTAIN PRESSURE. PHYSICIAN USED THREE ( TWO OF ONE LOT AND ONE OF ANOTHER), ALL GIVING SAME MALFUNCTION. ONCE THE DEVICE WAS PUMPED UP TO A PRESSURE, THE PRESSURE GAUGE RELEASED AND THERE WAS A LOSS OF PRESSURE, CAUSING THE TRACTION TO BE INEFFECTIVE IN HELPING BABY'S BIRTH. DEVICE HAS BEEN REPLACED WITH NEW LOT NUMBERED DEVICES. MOM WAS STABLE BUT BABY APGAR 2 AND BABY NEEDED RESUS."

  Patient problems: Insufficient Information

  MAUDE report 16854554 ↗
• InjuryOct 4, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IN THE CUSTOMERS WORDS: "38.2 WEEK GESTATION DELIVERY TO TYPE 1 DIABETIC MOM. DIFFICULT VACUUM ASSISTED DELIVERY WITH APPROXIMATELY 8 VACUUM PULLS. APGARS 4, 7, 8, RESUSCITATION NEEDED PPV X 5 MINUTES THEN CPAP X8 MINUTES. OBSERVED IN NURSERY FOR GRUNTING X4 HOURS THEN RELEASED TO FLOOR. BABE HAD POOR FEEDING AFTER DELIVERY. BABE DISCHARGED AFTER 36 HOURS AT REQUEST OF PARENTS. BABE REMAINED POOR FEEDING AT HOME AND CONTINUED TO LOSE WEIGHT ON CHECKS IN THE COMMUNITY. BABE WAS ADMITTED INTO HOSPITAL WITH HIGH BILI LEVEL AND POOR WEIGHT GAIN. ON EXAMINATION OF POOR FEEDING AND LETHARGY WITH HISTORY OF KIWI ASSISTED DELIVERY A HEAD XRAY AND CT WERE ORDERED. THE CT SHOWED FRACTURES OF THE RIGHT PARIETAL, LEFT FRONTAL AND TEMPORAL BONES. BILATERAL SUBDURAL TEMPORAL HEMATOMA, LARGER ON THE RIGHT AND SUBDURAL HEMATOMA IS ALSO PRESENT ON THE TENTORIUM CEREBELLI."

  Patient problems: Bone Fracture(s); Hematoma

  MAUDE report 15540753 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem

  A PREGNANT WOMAN FACING THE PROBLEM OF THREATENED PREMATURE DELIVERY STARTED LABOR AT A GESTATIONAL AGE OF 36 WEEKS. TO COPE WITH THE NRFS (NON REASSURING FETAL STATUS), HER BABY WAS SUBJECT TO SUCTION-DELIVERY WITH THE KIWI OMNI CUP. WHILE THE CUP WAS APPLIED TO THE RIGHT SIDE FROM THE BENDING POINT DUE TO AN ANOMALY OF ROTATION, SUCTIONING WAS SUCCESSFUL WITHOUT ANY SLIPPAGE AT THE 1ST ATTEMPT, THE BABY WEIGHING (B)(6) G, HOWEVER, WAS FOUND TO HAVE CEPHALHEMATOMA. SINCE IT GREW BIGGER IN A FEW DAYS, THE BABY GOT A CT AND WAS FOUND TO SUFFER A FRACTURED SKULL IN 3 PLACES.

  Patient problems: Cephalohematoma; Skull Fracture

  MAUDE report 10169156 ↗
• InjuryJan 6, 2020Pressure Problem; Pressure Problem

  DOCTOR APPLIED KIWI VACUUM CEPHALICALLY TO FETUS IN DISTRESS, KIWI VACUUM SUCTION INCREASED TO APPROPRIATE LEVEL AND KIWI VACUUM LITERALLY "FELL" OFF FETAL HEAD. THIS WAS NOT A POP-OFF SINCE NO TRACTION WAS APPLIED. A SECOND KIWI VACUUM WAS OPENED AND APPLIED WITH THE SAME OUTCOME. INFANT WAS ULTIMATELY DELIVERED BY FORCEPS. THIS INFANT REQUIRED ADVANCED RESUSCITATION MEASURES AND EVENTUALLY WAS TRANSFERRED TO A TERTIARY CARE CENTER FOR TREATMENT.

  Patient problems: Fetal Distress

  MAUDE report 9555978 ↗
• InjuryNov 18, 2019Use of Device Problem; Use of Device Problem

  FIRST TIME MOM SPONTANEOUS LABOR. UNKNOWN INDICATION FOR VACUUM DELIVERY. EVEN LESS INFORMATION AVAILABLE. NO MENTION OF POSITION OR STATION AT APPLICATION BUT REPORTED 3 POP-OFFS DURING THE DELIVERY. AGAIN, PROCUP WAS USED. NO MENTION OF NUMBER OF PULLS. TWELVE HOURS AFTER BIRTH BABY CODED AND WAS RESUSCITATED AND TRANSFERRED TO NICU. BABY IS CURRENTLY ON VENTILATOR, BUT STABLE CONDITION. CT SHOWED EVIDENCE OF A SUBGALEAL, SUBDURAL AND SUBARACHNOID HEMORRHAGES PRESENT. BABY REMAINS STABLE IN THE NICU AND HAS NOT HAD ANY SEIZURE ACTIVITY.

  Patient problems: Hemorrhage, Subgaleal

  MAUDE report 9335766 ↗
• InjurySep 23, 2019Detachment of Device or Device Component

  PHYSICIAN REPORTED A SUBGALEAL HEMORRHAGE ASSOCIATED WITH A VACUUM DELIVERY USING A KIWI OMNI-CUP. 4 POP-OFFS WERE REPORTED. THE OUTCOME OF THE FETUS WAS GOOD.

  Patient problems: Hemorrhage, Subgaleal; No Consequences Or Impact To Patient

  MAUDE report 9105386 ↗
• MalfunctionMay 31, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NO REPORT OF ANY INJURY TO EITHER THE MOTHER OR THE BABY. SAMPLE HAS BEEN RETURNED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8661101 ↗
• MalfunctionMay 31, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THEY DID NOT MANAGE TO ACHIEVE VACUUM WITH THE UNIT. NO CONSEQUENCES FOR PATIENT OR BABY BUT A DELAY OF 15 MIN WAS REPORTED. NO FURTHER INFORMATION WAS REPORTED. NO SAMPLE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8661093 ↗
• MalfunctionDec 5, 2018Suction Failure

  THE KIWI VACUUM WAS OPENED AND INTENDED TO BE USED DURING A CESAREAN DELIVERY. THE PHYSICIANS WERE HAVING DIFFICULTY EXTRACTING THE INFANT SO TO ASSIST IN DELIVERY, IT WAS REPORTED THAT THE VACUUM SUCTION DID NOT ACHIEVE SUCTION.

  Patient problems: No Information

  MAUDE report 8132450 ↗

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.