Kiwi® OmniCup® VAC-6000MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00814247020642), received between Sep 18, 2017 and Nov 22, 2024 — classified as 1 death, 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Mar 9, 2026Class IIOpen, Classified

   Due to complaints of device breakage at the traction force gauge to handle joint.

   Z-1945-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2024

  WHEN APPLYING THE VACUUM, AND SUCTION WAS ATTEMPTED, THE DEVICE "FELL APART".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757030 ↗
• InjuryNov 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PROLONGED 2ND STAGE. 2 PULLS GIVEN. KIWI CAME OFF BEGINNING OF 2ND PULL. SUBGALEAL HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 20612399 ↗
• InjuryNov 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ABRASIONS WERE MADE ON THE ADSORPTION AREA (HEAD) OF THE CHILD.

  Patient problems: Abrasion

  MAUDE report 20612225 ↗
• DeathMar 15, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IN THE CUSTOMER'S WORDS: "OPERATIVE VAGINAL DELIVERY VIA KIWI VACUUM. INFANT WITH SUBGALEAL BLEED".

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16546287 ↗
• InjuryAug 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IN THE CUSTOMERS WORD: "THE KIWI VACCUM DEVICE WAS NOT ABLE TO MAINTAIN SUCTION PRESSURE AFTER PUMPED UP TO 65KPA, CREATES HISSING SOUND AND SUCTION PRESSURE QUICKLY REDUCE DOWN TO 15KPA". "2ND KIWI VACCUM DEVICE NEED TO BE USED TO EFFECT DELIVERY OF THE BABY AND THIS CAUSED EXTENSIVE SUBAPONEUROTIC HAEMORRHAGE (SAH) AND HYPOXIC ISCHAEMIC ENCEPHALOPATHY (HIE)" "VACCUM ASSISTED DELIVERY FOR FETAL BRADYCARDIA". "1ST KIWI VACCUUM DEVICE APPLIED AT 0215H, TESTED PRIOR TO APPLICATION ON FETAL HEAD AND SUCTION PRESENT, ABLE TO CREATE SUCTION PRESSURE UP TO 65KPA HOWEVER UPON TRACTION NOTED HISSING SOUND AND NOTICED SUCTION PRESSURE DROPPED TO 15KPA, REPEATED PUMP SUCTION ATTEMPTED BUT SIMILAR PROBLEM. 2ND KIWI DEVICE WAS OBTAINED, TESTED AND FUNCTIONING WELL, APPLIED AT 0218H, SUCTION MAINTAINED AND SUCCESSFUL DELIVERY AT 0222H". "BABY WAS BORN PALE REQUIRING INOTROPE SUPPORT DUE TO EXTENSIVE SAH, ALSO REQUIRED PACKED CELL AND FRESH FROZEN PLASMA TRANSFUSION. ALSO SUSTAINED HIE GRADE 2".

  Patient problems: Encephalopathy; Intracranial Hemorrhage

  MAUDE report 15321973 ↗
• InjuryMay 22, 2019Human-Device Interface Problem; Human-Device Interface Problem

  KIWI APPLIED CORRECTLY THEN DEFLATED AT FIRST ATTEMPT TO PULL. NOT A POP-OFF. THERE WAS CAPUT THIS TIME SO VACUUM HAD TO BE ACHIEVED. IT WAS REPORTED THE PATIENT WAS TRAUMATIZED BUT NO FURTHER DETAIL PROVIDED. THE PATIENT UNDERWENT A C-SECTION UNDER GENERAL ANESTHESIA. NO SAMPLE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8633595 ↗
• InjurySep 18, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BABY HAD A SKULL FRACTURE POST USE.

  Patient problems: Skull Fracture

  MAUDE report 6874427 ↗

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-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.