Kiwi® OmniCup® VAC-6000MERecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00814247020635), received between Dec 11, 2017 and Sep 28, 2026 — classified as 7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Insufficient Device Problem Information

  Patient problems: Skin Tears

  MAUDE report 50923231 ↗
• MalfunctionNov 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DESCRIPTION OF INCIDENT: MALFUNCTION DURING THE REMOVAL OF THE KIWI SUCTION CUP FROM THE NEWBORN'S OCCIPUT. THE REMOVAL BUTTON ON THE HANDLE WAS STUCK. IT WAS IMPOSSIBLE TO UNBLOCK IT AND CREATE THE NECESSARY SUCTION TO REMOVE THE CUP. IT WAS NECESSARY TO DISASSEMBLE IT, REMOVING THE SPRING FROM THE HANDLE. THIS CAUSED A DELAY IN REMOVAL, RESULTING IN A SIGNIFICANT CEPHALIC BUMP THAT COULD HAVE CAUSED A SUBCUTANEOUS HEMATOMA. THE BABY'S OCCIPUT WAS PURPLISH (SIGNIFICANT OCCIPITAL HUMP + SMALL HEMATOMA). CURRENT PATIENT CONDITION: SIGNIFICANT OCCIPITAL HUMP THAT MAY HAVE CAUSED A SUBCUTANEOUS HEMATOMA. THE BABY'S OCCIPUT WAS PURPLISH (SIGNIFICANT OCCIPITAL HUMP + SMALL HEMATOMA).

  Patient problems: Hematoma

  MAUDE report 23511045 ↗
• MalfunctionOct 15, 2024Mechanical Problem; Mechanical Problem

  'USE OF KIWI (VACUUM) NECESSARY FOR PLANNED CAESAREAN SECTION. KIWI CAME LOOSE AFTER APPLICATION TO THE HEAD AND PIECES (CAP AND FILTER) CAME LOOSE. THE COVER WAS FOUND, BUT THE FILTER (SMALL TRANSPARENT SOMETHING OF +/- 0.5 CM) ITSELF WAS NOT. IT IS NOT ASSUMED THAT THE FILTER IS LEFT IN THE ABDOMEN, BUT THERE IS NO CERTAINTY. IF THIS WERE THE CASE, THIS SHOULD NOT CAUSE ANY PROBLEMS. HAVE YOU RECEIVED THIS MESSAGE FROM OTHER CUSTOMERS? THEY DID NOT KEEP THE PACKAGING, SO I DO NOT KNOW WHICH LOT NUMBER THIS IS.

  Patient problems: Insufficient Information

  MAUDE report 20454722 ↗
• InjuryApr 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IN THE CUSTOMERS WORDS: "SCALP LESIONS AFTER USE ON TWO BABIES". "THE BABY'S SCALP WAS ALMOST TORN OFF. THE CHILD HAD TO BE TRANSFERRED TO A NEONATAL UNIT AFTER BIRTH. HE IS NOW BEING MONITORED BY A SPECIALIST FOR ANY NEUROLOGICAL AFTER-EFFECTS." FOLLOW UPS HAVE BEEN ATTEMPTED BUT TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Laceration(s)

  MAUDE report 19037652 ↗
• InjuryApr 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IN THE CUSTOMERS WORDS: "SCALP LESIONS AFTER USE ON TWO BABIES" "THE BABY'S SCALP WAS ALMOST TORN OFF. THE CHILD HAD TO BE TRANSFERRED TO A NEONATAL UNIT AFTER BIRTH. HE IS NOW BEING MONITORED BY A SPECIALIST FOR ANY NEUROLOGICAL AFTER-EFFECTS." FOLLOW UPS HAVE BEEN ATTEMPTED BUT TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Laceration(s)

  MAUDE report 19037636 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FROM GOOGLE TRANSLATE: "DESCRIPTION OF THE INCIDENT: NEWBORN WITH LEFT PARIETAL LOCK AFTER CODE RED CESAREAN SECTION FOLLOWING FAILURE EXTRACTION BY SUCTION CUP. THE SUCTION CUP WAS NOT PRESERVED, SO THE BATCH NUMBER OF THE MATERIAL IS NOT KNOWN." IN STATE OF 'PARIETAL LOCK' I THINK THAT THE TRANSLATION 'PARIETAL GROOVE'. IT'S MEANS THE SKULL IS FRACTURED AND A FRAGMENT OF SKULL BONE IS PUSHED INWARDS."

  Patient problems: Skull Fracture

  MAUDE report 18529563 ↗
• InjuryNov 17, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IN THE CUSTOMERS WORDS "INCIDENT : " DIFFICULTY IN PERFORMING THE VACUUM IMMEDIATELY AFTER APPLICATION, PROLONGING THE PERIOD EXPULSION AND PUTTING THE NEWBORN'S LIFE AT RISK". IT IS UNKNOWN IF THE DEVICE IS AVAILABLE TO BE SENT BACK; IF THE DEVICE IS RETURNED, A NEW COMPLAINT INVESTIGATION WILL BE OPENED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18163762 ↗
• InjuryMar 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MY PATIENT WAS ALREADY FULLY EFFACED, HEAD IS ON +1 BUT WITH SEVERE FETAL DISTRESS. SO I DECIDED TO USE THE KIWI FOR FASTER DELIVERY. AS I APPLIED THE VACUUM THE HEAD WAS NOT WORKING AS THE WIRE BETWEEN THE HANDLE AND THE CAP WAS COMPLETELY BROKEN. CAUSING TRAMA TO THE BABY.

  Patient problems: Shock, Traumatic

  MAUDE report 8425692 ↗
• InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE ARE EXPERIENCING DIFFICULTIES WITH OUR VACUUM DELIVERIES IN THE PAST FEW DAYS. IT SEEMS THAT KIWI OMNICUP IS NOT PROVIDING ENOUGH VACUUM TO APPLY SUFFICIENT PRESSURE IN ORDER TO FACILITATE A SUCCESSFUL DELIVERY (WITH REPEATED POP-OFF ISSUE).

  Patient problems: Hypoxia in Utero

  MAUDE report 8143739 ↗
• MalfunctionDec 11, 2017Entrapment of Device

  KIWI BREAKS UP DURING DELIVERY THE CUP PART WAS CAUGHT ON THE CHILD'S HEAD (THE CHILD WAS NOT BORN YET) AND THE HOSE+ HANDLE WAS LEFT IN THE HAND OF THE LEADER IN THE MIDDLE OF THE OPERATION. THE REMOVAL OF THE CUP WAS PAINFUL AND PAINFUL BIRTH FOR THE BABY WHILE THE VACUUM WAS IN THE CUP WHILE THE HOSE AND THE HANDLE WERE REMOVED. THE OPERATION WAS NOT DIFFICULT (IT DID NOT HAVE TO BE EXCEPTIONALLY HARD). WITH A NEW CUP, THE CHILD WAS BORN WITHOUT PROBLEMS.

  Patient problems: Pain

  MAUDE report 7106744 ↗

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.