Kiwi® OmniCup® VAC-6000MTERecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00814247020659), received between Dec 11, 2017 and Apr 22, 2026 — classified as 1 death, 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 reports).

1 FDA recall record name this device's identifier.

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. Aug 6, 2019Class IITerminated

   There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.

   Z-2072-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Material Separation; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION FROM USER IS AS FOLLOWS: "13 APR 2026: UPDATED INFORMATION: "ONE OF THESE BATCHES": 251652, 250956, 251597. "OUTSIDE PAPERWORK WAS DISCARDED AND NOT ABLE TO BE RETRIEVED." INCIDENT DESCRIPTION: BABY WAS DELIVERED AT 41+3 WEEKS FOLLOWING AN UNCOMPLICATED ANTENATAL COURSE. THE BABY WAS BORN IN POOR CONDITION AFTER FETAL BRADYCARDIA AND A PROLONGED INSTRUMENTAL DELIVERY DUE TO A SNAPPED KIWI, MEETING CRITERIA A AND B FOR THERAPEUTIC HYPOTHERMIA. SHE WAS INTUBATED AND VENTILATED SHORTLY AFTER BIRTH, TRANSFERRED TO HEARTLANDS HOSPITAL, BIRMINGHAM FOR COOLING ON DAY OF BIRTH, AND REPATRIATED TO KMH ON (B)(6) 2026. THERAPEUTIC HYPOTHERMIA WAS COMPLETED, AND SHE WAS REWARMED ON 20/03. SHE REQUIRED MECHANICAL VENTILATION UNTIL 20/03, WHEN SHE WAS SUCCESSFULLY EXTUBATED. SINCE THEN, SHE HAS BEEN SELF-VENTILATING IN AIR. SHE WAS INITIALLY SCREENED FOR SEPSIS; INFECTION MARKERS WERE NORMAL AND BLOOD CULTURES WERE STERILE, SO ANTIBIOTICS WERE DISCONTINUED. SHE HAS REMAINED CLINICALLY STABLE WITH NORMAL NEUROLOGICAL EXAMINATIONS. MRI PERFORMED SHOWED RESTRICTED DIFFUSION OF THE INTERNAL CAPSULE CONSISTENT WITH MODERATE TO SEVERE HIE. IT IS LIKELY THAT SHE MAY DEVELOP CEREBR

  Patient problems: Distress; Fetal Distress

  MAUDE report 24954557 ↗
• MalfunctionMar 12, 2026Material Separation

  TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "THIS IS A FOLLOW-UP TO OUR TELEPHONE CONVERSATION YESTERDAY WITH (B)(6) REGARDING A MEDICAL DEVICE VIGILANCE REPORT CONCERNING KIWI OMNICUP TRACTION FORCE DEVICES AT THE (B)(6) HOSPITAL. THE DEVICE IN QUESTION IS THE KIWI OMNICUP TRACTION FORCE VAC-6000MTE, BATCH NUMBER 251652. WE HAVE OBSERVED THAT THE TRACTION INDICATOR CARTRIDGE DETACHES FROM THE VACUUM EXTRACTOR HANDLE DURING USE, BOTH DURING VAGINAL DELIVERIES AND CESAREAN SECTIONS. THIS MALFUNCTION HAS RESULTED IN INJURIES TO NEWBORNS, DOCUMENTED IN AT LEAST FOUR SEPARATE INCIDENTS, REPORTED BY AT LEAST TWO OBSTETRICIANS AT OUR FACILITY. TO DATE, A TOTAL OF 75 DEVICES FROM THIS BATCH HAVE BEEN IDENTIFIED AND IMMEDIATELY PLACED IN QUARANTINE. FURTHERMORE, OBSTETRICIANS ARE NOW REFUSING TO USE THIS DEVICE AND ARE TURNING TO ALTERNATIVE SOLUTIONS, SUCH AS SPATULAS OR FORCEPS, TO ENSURE PATIENT SAFETY. WE REQUEST THE IMMEDIATE RECALL OF THIS BATCH AND ITS REPLACEMENT WITH COMPLIANT DEVICES TO ENSURE CONTINUITY OF CARE UNDER OPTIMAL SAFETY CONDITIONS. THANK YOU IN ADVANCE FOR KEEPING US INFORMED OF ANY DEVELOPMENTS IN THIS MATTER. SINCE THE CHANGE IN MEDICAL DEVICES, THE INSERTION OF

  Patient problems: Insufficient Information

  MAUDE report 24586233 ↗
• MalfunctionMar 12, 2026Material Separation

  TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "THIS IS A FOLLOW-UP TO OUR TELEPHONE CONVERSATION YESTERDAY WITH (B)(6) REGARDING A MEDICAL DEVICE VIGILANCE REPORT CONCERNING KIWI OMNICUP TRACTION FORCE DEVICES AT THE (B)(6) HOSPITAL. THE DEVICE IN QUESTION IS THE KIWI OMNICUP TRACTION FORCE VAC-6000MTE, BATCH NUMBER 251652. WE HAVE OBSERVED THAT THE TRACTION INDICATOR CARTRIDGE DETACHES FROM THE VACUUM EXTRACTOR HANDLE DURING USE, BOTH DURING VAGINAL DELIVERIES AND CESAREAN SECTIONS. THIS MALFUNCTION HAS RESULTED IN INJURIES TO NEWBORNS, DOCUMENTED IN AT LEAST FOUR SEPARATE INCIDENTS, REPORTED BY AT LEAST TWO OBSTETRICIANS AT OUR FACILITY. TO DATE, A TOTAL OF 75 DEVICES FROM THIS BATCH HAVE BEEN IDENTIFIED AND IMMEDIATELY PLACED IN QUARANTINE. FURTHERMORE, OBSTETRICIANS ARE NOW REFUSING TO USE THIS DEVICE AND ARE TURNING TO ALTERNATIVE SOLUTIONS, SUCH AS SPATULAS OR FORCEPS, TO ENSURE PATIENT SAFETY. WE REQUEST THE IMMEDIATE RECALL OF THIS BATCH AND ITS REPLACEMENT WITH COMPLIANT DEVICES TO ENSURE CONTINUITY OF CARE UNDER OPTIMAL SAFETY CONDITIONS. THANK YOU IN ADVANCE FOR KEEPING US INFORMED OF ANY DEVELOPMENTS IN THIS MATTER. SINCE THE CHANGE IN MEDICAL DEVICES, THE INSERTION OF

  Patient problems: Insufficient Information

  MAUDE report 24580751 ↗
• MalfunctionMar 12, 2026Material Separation

  TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "DESCRIPTION OF THE INCIDENT: OCCURRENCE OF THE INCIDENT; DURING AN INSTRUMENTAL DELIVERY USING A KIWI VACUUM EXTRACTOR DUE TO FAILURE TO PROGRESS AND FETAL HEART RATE ABNORMALITIES, THE DEVICE BROKE. THE INCIDENT OCCURRED 3 TIMES WITH 3 NEW DEVICES, LEADING TO THE MEDICAL DECISION TO USE SUZOR FORCEPS. IMMEDIATE ACTION: REPLACEMENT OF 3 VACUUM EXTRACTORS WITH NEW DEVICES. REPLACEMENT OF THE DEVICE WITH SUZOR FORCEPS. IMMEDIATE APPARENT CONSEQUENCES: FOR PATIENTS: FOR THE MOTHER; PROLONGED DELIVERY WITH INCREASED PAIN, STRESS WITH POST-TRAUMATIC ANXIETY, AND OTHER POTENTIAL RISKS. FOR THE BABY: FETAL DISTRESS IN A NEWBORN ALREADY EXPERIENCING AN ABNORMAL HEART RHYTHM, PROLONGED DELIVERY TIME, WITH POTENTIAL INCREASED PAIN, PROBABLE POST-TRAUMATIC STRESS. FOR HEALTHCARE PROFESSIONALS: INSECURITY, EVENT MANAGEMENT, STRESS, WORKLOAD OVERLOAD. FOR THE FACILITY: ECONOMIC COST DUE TO THE NEED FOR ADDITIONAL EQUIPMENT AND OTHER POTENTIAL CONSEQUENCES ON PATIENT CARE. WE WOULD APPRECIATE IT IF YOU COULD INFORM US WHETHER THIS TYPE OF INCIDENT IS RECURRING OR ISOLATED. ASSURED THAT WE SHARE THIS SAME COMMITMENT TO IMPROVING THE QUALITY AND SAFE

  Patient problems: Anxiety; Distress; Fetal Distress; Pain

  MAUDE report 24580749 ↗
• MalfunctionMar 12, 2026Material Separation

  TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "DESCRIPTION OF THE INCIDENT OCCURRENCE OF THE INCIDENT: DURING AN INSTRUMENTAL DELIVERY USING A KIWI VACUUM EXTRACTOR DUE TO FAILURE TO PROGRESS AND FETAL HEART RATE ABNORMALITIES, THE DEVICE BROKE. THE INCIDENT OCCURRED 3 TIMES WITH 3 NEW DEVICES, LEADING TO THE MEDICAL DECISION TO USE SUZOR FORCEPS. IMMEDIATE ACTION: REPLACEMENT OF 3 VACUUM EXTRACTORS WITH NEW DEVICES. REPLACEMENT OF THE DEVICE WITH SUZOR FORCEPS. IMMEDIATE APPARENT CONSEQUENCES: FOR PATIENTS: FOR THE MOTHER: PROLONGED DELIVERY WITH INCREASED PAIN, STRESS WITH POST-TRAUMATIC ANXIETY, AND OTHER POTENTIAL RISKS. FOR THE BABY: FETAL DISTRESS IN A NEWBORN ALREADY EXPERIENCING AN ABNORMAL HEART RHYTHM, PROLONGED DELIVERY TIME, WITH POTENTIAL INCREASED PAIN, PROBABLE POST-TRAUMATIC STRESS. FOR HEALTHCARE PROFESSIONALS: INSECURITY, EVENT MANAGEMENT, STRESS, WORKLOAD OVERLOAD. FOR THE FACILITY: ECONOMIC COST DUE TO THE NEED FOR ADDITIONAL EQUIPMENT AND OTHER POTENTIAL CONSEQUENCES ON PATIENT CARE. WE WOULD APPRECIATE IT IF YOU COULD INFORM US WHETHER THIS TYPE OF INCIDENT IS RECURRING OR ISOLATED. ASSURED THAT WE SHARE THIS SAME COMMITMENT TO IMPROVING THE QUALITY AND SAFET

  Patient problems: Anxiety; Distress; Fetal Distress; Pain

  MAUDE report 24579451 ↗
• MalfunctionMar 12, 2026Material Separation

  TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "DESCRIPTION OF THE INCIDENT/ OCCURRENCE OF THE INCIDENT: DURING AN INSTRUMENTAL DELIVERY USING A KIWI VACUUM EXTRACTOR DUE TO FAILURE TO PROGRESS AND FETAL HEART RATE ABNORMALITIES, THE DEVICE BROKE. THE INCIDENT OCCURRED 3 TIMES WITH 3 NEW DEVICES, LEADING TO THE MEDICAL DECISION TO USE SUZOR FORCEPS. IMMEDIATE ACTION: REPLACEMENT OF 3 VACUUM EXTRACTORS WITH NEW DEVICES. REPLACEMENT OF THE DEVICE WITH SUZOR FORCEPS. IMMEDIATE APPARENT CONSEQUENCES: FOR PATIENTS: FOR THE MOTHER: PROLONGED DELIVERY WITH INCREASED PAIN, STRESS WITH POST-TRAUMATIC ANXIETY, AND OTHER POTENTIAL RISKS. FOR THE BABY: FETAL DISTRESS IN A NEWBORN ALREADY EXPERIENCING AN ABNORMAL HEART RHYTHM, PROLONGED DELIVERY TIME, WITH POTENTIAL INCREASED PAIN, PROBABLE POST-TRAUMATIC STRESS. FOR HEALTHCARE PROFESSIONALS: INSECURITY, EVENT MANAGEMENT, STRESS, WORKLOAD OVERLOAD. FOR THE FACILITY: ECONOMIC COST DUE TO THE NEED FOR ADDITIONAL EQUIPMENT AND OTHER POTENTIAL CONSEQUENCES ON PATIENT CARE. WE WOULD APPRECIATE IT IF YOU COULD INFORM US WHETHER THIS TYPE OF INCIDENT IS RECURRING OR ISOLATED. ASSURED THAT WE SHARE THIS SAME COMMITMENT TO IMPROVING THE QUALITY AND SAFE

  Patient problems: Anxiety; Distress; Fetal Distress; Pain

  MAUDE report 24579026 ↗
• MalfunctionMar 12, 2026Material Separation

  TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "THIS IS A FOLLOW-UP TO OUR TELEPHONE CONVERSATION YESTERDAY WITH (B)(6) REGARDING A MEDICAL DEVICE VIGILANCE REPORT CONCERNING KIWI OMNICUP TRACTION FORCE DEVICES AT THE (B)(6) HOSPITAL. THE DEVICE IN QUESTION IS THE KIWI OMNICUP TRACTION FORCE VAC-6000MTE, BATCH NUMBER 251652. WE HAVE OBSERVED THAT THE TRACTION INDICATOR CARTRIDGE DETACHES FROM THE VACUUM EXTRACTOR HANDLE DURING USE, BOTH DURING VAGINAL DELIVERIES AND CESAREAN SECTIONS. THIS MALFUNCTION HAS RESULTED IN INJURIES TO NEWBORNS, DOCUMENTED IN AT LEAST FOUR SEPARATE INCIDENTS, REPORTED BY AT LEAST TWO OBSTETRICIANS AT OUR FACILITY. TO DATE, A TOTAL OF (B)(4) DEVICES FROM THIS BATCH HAVE BEEN IDENTIFIED AND IMMEDIATELY PLACED IN QUARANTINE. FURTHERMORE, OBSTETRICIANS ARE NOW REFUSING TO USE THIS DEVICE AND ARE TURNING TO ALTERNATIVE SOLUTIONS, SUCH AS SPATULAS OR FORCEPS, TO ENSURE PATIENT SAFETY. WE REQUEST THE IMMEDIATE RECALL OF THIS BATCH AND ITS REPLACEMENT WITH COMPLIANT DEVICES TO ENSURE CONTINUITY OF CARE UNDER OPTIMAL SAFETY CONDITIONS. THANK YOU IN ADVANCE FOR KEEPING US INFORMED OF ANY DEVELOPMENTS IN THIS MATTER. SINCE THE CHANGE IN MEDICAL DEVICES, THE INSERTIO

  Patient problems: Insufficient Information

  MAUDE report 24578956 ↗
• MalfunctionMar 12, 2026Material Separation

  TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "THIS IS A FOLLOW-UP TO OUR TELEPHONE CONVERSATION YESTERDAY WITH (B)(6) REGARDING A MEDICAL DEVICE VIGILANCE REPORT CONCERNING KIWI OMNICUP TRACTION FORCE DEVICES AT THE (B)(6) HOSPITAL. THE DEVICE IN QUESTION IS THE KIWI OMNICUP TRACTION FORCE VAC-6000MTE, BATCH NUMBER 251652. WE HAVE OBSERVED THAT THE TRACTION INDICATOR CARTRIDGE DETACHES FROM THE VACUUM EXTRACTOR HANDLE DURING USE, BOTH DURING VAGINAL DELIVERIES AND CESAREAN SECTIONS. THIS MALFUNCTION HAS RESULTED IN INJURIES TO NEWBORNS, DOCUMENTED IN AT LEAST FOUR SEPARATE INCIDENTS, REPORTED BY AT LEAST TWO OBSTETRICIANS AT OUR FACILITY. TO DATE, A TOTAL OF (B)(4) DEVICES FROM THIS BATCH HAVE BEEN IDENTIFIED AND IMMEDIATELY PLACED IN QUARANTINE. FURTHERMORE, OBSTETRICIANS ARE NOW REFUSING TO USE THIS DEVICE AND ARE TURNING TO ALTERNATIVE SOLUTIONS, SUCH AS SPATULAS OR FORCEPS, TO ENSURE PATIENT SAFETY. WE REQUEST THE IMMEDIATE RECALL OF THIS BATCH AND ITS REPLACEMENT WITH COMPLIANT DEVICES TO ENSURE CONTINUITY OF CARE UNDER OPTIMAL SAFETY CONDITIONS. THANK YOU IN ADVANCE FOR KEEPING US INFORMED OF ANY DEVELOPMENTS IN THIS MATTER. SINCE THE CHANGE IN MEDICAL DEVICES, THE INSERTIO

  Patient problems: Insufficient Information

  MAUDE report 24578954 ↗
• MalfunctionNov 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DESCRIPTION OF THE INCIDENT: DURING AN INSTRUMENTAL DELIVERY FOR BRADYCARDIA IN THE BABY, DESPITE EASY PLACEMENT OF THE DEVICE AND ADHESION OF THE SUCTION CUP TO THE BABY'S HEAD, DURING THE MANEUVER PERFORMED BY THE OBSTETRICIAN, THE HANDLE OF THE DEVICE BECAME COMPLETELY DETACHED FROM THE REST OF THE DEVICE, WITH THE SPRINGS EXTERIORIZING AND ONE SUCTION CUP STILL IN PLACE. CURRENT STATE OF THE PATIENT: FOR THE MOTHER: PROLONGATION OF THE EXTRACTION DURATION WITH INCREASED PAIN, STRESS WITH POST-TRAUMATIC ANXIETY, AND OTHER POTENTIAL RISKS. FOR THE BABY: FETAL DISTRESS IN A NEWBORN ALREADY EXPERIENCING BRADYCARDIA DUE TO THE PROLONGED EXTRACTION TIME, INCREASED PAIN DUE TO MULTIPLE VACUUM REPOSITIONINGS REQUIRING UNUSUAL MEDICAL INTERVENTION, PROBABLE POST-TRAUMATIC STRESS. FOR THE OBSTETRIC SURGEON: RISK OF FALLING DURING THE DELIVERY PROCEDURE WITH A RISK OF THE NEWBORN FALLING.

  Patient problems: Distress; Fetal Distress; Pain

  MAUDE report 23465508 ↗
• MalfunctionOct 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INCIDENT DESCRIPTION: OCCURRENCE OF THE INCIDENT: THE VACUUM CUP USED DID NOT FUNCTION PROPERLY: "THE CABLE STRETCHED ABNORMALLY WITHOUT BREAKING, INSTEAD OF PROVIDING THE RESISTANCE TO ALLOW TRACTION." IMMEDIATE ACTION: - REPLACEMENT OF THE DEVICE WITH A NEW ONE: "ATTEMPTED VACUUM CUP PLACEMENT DUE TO FETAL BRADYCARDIA, PREVENTING THE FETAL MOBILE FROM PROGRESSING." CODE RED CAESAREAN SECTION FOR BRADYCARDIA AND INSTRUMENT FAILURE. IMMEDIATE APPARENT CONSEQUENCES: FOR PATIENTS: FOR THE MOTHER, PROLONGED DELIVERY TIME WITH SIGNIFICANT PAIN AND A CODE RED CAESAREAN SECTION. FOR THE BABY: BRADYCARDIA AND POTENTIAL RISK OF FETAL DISTRESS. FOR PROFESSIONALS: EVENT MANAGEMENT - STRESS - WORK OVERLOAD.

  Patient problems: Discomfort; Pain

  MAUDE report 23370346 ↗
• DeathApr 20, 2021Material Separation; Device Slipped; Therapeutic or Diagnostic Output Failure

  DESCRIPTION PROVIDED BY THE CUSTOMER AND ANSWERS TO FOLLOW UP QUESTIONS PLACED KIWI. WITH THE FIRST TRACTION THE HANDLE SEPARATED. VACUUM WAS NOT RELEASED SPONTANEOUSLY. TRIED ANOTHER TRACTION: CUP POPPED OFF. VACUUM WAS CHOSEN OUT OF FETAL URGENCY. FOLLOWING TO THIS SECTION VACUUM FAILED (NOT SURE WHAT IS MEANT HERE EXACTLY). SUSPICION OF ANEMIA CHILD BECAUSE OF HEMATOMA ON THE HEAD. BABY DIED AFTER REANIMATION. RESEARCH WILL FOLLOW. WAS THE INFANT BORN DECEASED AND RESUSCITATED? THE NEONATE HAS BEEN RESUSCITATED; AS (B)(6) 2023. GESTATIONAL AGE OF INFANT GESTATIONAL AGE 38 WEEKS AND 2 DAYS POSITION AND STATION OF INFANT AT TIME OF VACUUM PLACEMENT BONY PART JUST ON H3 WITH POSITION OF ANALV. REASON FOR VACUUM PLACEMENT--I KNOW IT SAYS FETAL URGENCY--WAS THERE CONCERN WITH THE FETAL MONITOR TRACING? IF SO, WHY (PROLONGED DECELERATION, ETC)? SUSPECTED FETAL DISTRESS: ABNORMAL CTG WITH TACHYCARDIA, DECREASED VARIABILITY AND COMPLICATED DECELERATIONS. IN ADDITION, MOTHER SUDDENLY HAD A FEVER TO 39.2 RECTAL. HOW LONG WAS THE VACUUM ON THE FETAL HEAD? 11 MINUTES IF IT WAS A KIWI MT DEVICE, DID THEY NOTE THE PULLING FORCE ON THE TRACTION FORCE INDICATOR WITH THE 2 PULLS? WE ARE NOT USED

  Patient problems: Hematoma

  MAUDE report 11695444 ↗
• InjuryFeb 11, 2020Suction Problem; Suction Problem

  TERM +5 DAYS. SPONTANEOUS ASSIST OF LABOUR PROGRAMED WELL DURING 1ST STAGE OF LABOUR AT 15:15 FULLY DILATED. KIWI DELIVERY REQUIRED FOR ABNORMAL CTE - SUBACUTE HYPOXIA. ON 2ND TRACTION - CUP DETACHED OFF FETAL HEAD. 2ND KIWI USED - HEAD DELIVERED FOLLOWING 3RD PULL.

  Patient problems: Hypoxia

  MAUDE report 9696600 ↗
• InjuryJul 26, 2019Device Dislodged or Dislocated; Suction Failure

  A REPORT HAS BEEN RECEIVED REPORTING THE FOLLOWING: KIWI DISLODGED. LOST SUCTION. CEPHALHAEMATOMA. BABY TO NICU. IT WAS REPORTED THAT ANOTHER CLINICAL INNOVATIONS KIWI WAS USED SUCCESSFULLY. WE ARE IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION.

  Patient problems: Cephalohematoma

  MAUDE report 8834204 ↗
• InjuryJun 25, 2019Use of Device Problem; Use of Device Problem

  AN INCIDENT HAS BEEN REPORTED THAT OCCURRED IN (B)(6): LAYING A KIWI SUCKER DURING A DELIVERY, THEN TRACTION AND PROGRESSION OF THE HEAD. RELEASE OF THE SUCTION CUP. SECOND INSERTION OF THE SUCKER, PROGRESSION OF CHILDBIRTH THEN OBSERVATION OF THE PURPLISH AND EDEMATOUS LEFT EYE. DECISION TO REMOVE THE SUCTION CUP. CONFIRMATION OF A BRUISE AND EDEMA IN THE LEFT EYE FUSING AT THE LEVEL OF FOREHEAD AND AT THE BASE OF THE NOSE. SLIGHT RIGHT EYE EDEMA WITHOUT BRUISE. NEW INFORMATION REPORTED: WE ARE FOLLOWING THIS CASE VERY CLOSELY, AT THIS STAGE THE LESION SEEMS NOT TOO SEVERE AND THE BABY RECOVERS WELL.

  Patient problems: Bruise/Contusion; Edema; Injury; Swelling

  MAUDE report 8732003 ↗
• InjuryApr 30, 2019Device Dislodged or Dislocated; No Pressure; Pressure Problem; Pressure Problem

  APPLIED KIWI AT THE RIGHT FLEXION POINT FOR (B)(6) BABY WITH OA PRESENTATION. CUP PRESSURE WAS NORMAL AT THE BEGINNING AS SHOWN ON MONITOR AND SUDDENLY PRESSURE WAS DROPPED + CUP DISLODGED WITH TRACTION. NOT A POP-OFF, (B)(6) SPONTANEOUS ONSET OF LABOR, BMI 24.34 EXPERIENCED USER. USED FORCEPS BABY WENT TO HDU FOR OBSERVATION FOR HEMATOMA.

  Patient problems: Cephalohematoma; Hematoma

  MAUDE report 8567034 ↗
• InjuryApr 3, 2019Deflation Problem; Activation Problem; Activation Problem

  2 X KIWIS DEFLATED NO CAPUT. IT IS NOT CLEAR IF HEMATOMA WAS FROM KIWICUP OR FORCEPS. IT WAS NOT A VISIBLE TEAR. MOTHER WENT TO HDU UNIT, DUE TO HEMATOMA, BOTH ARE FINE.

  Patient problems: Hematoma; Vaginal Mucosa Damage

  MAUDE report 8479632 ↗
• InjuryJun 11, 2018Insufficient Device Problem Information

  INFANT PASSED DURING DELIVERY DUE TO SUFFOCATION. TWO KIWI VACUUM DELIVERY SYSTEMS WERE USED DURING THE DELIVERY.

  Patient problems: Death; Suffocation

  MAUDE report 7589567 ↗
• InjuryJun 11, 2018Insufficient Device Problem Information

  INFANT PASSED DURING DELIVERY DUE TO SUFFOCATION. TWO KIWI VACUUM DELIVERY SYSTEMS WERE USED DURING THE DELIVERY.

  Patient problems: Death; Suffocation

  MAUDE report 7589560 ↗
• InjuryJan 31, 2018Suction Problem

  EVENT DESCRIPTION PROVIDED BY THE DISTRIBUTOR: "JUNIOR REG APPLIED CUP - POP OFF, IT WAS DISCARDED. DR (B)(6) APPLIED SECOND CUP (SAMPLE ENCLOSED) BABY MADE PROGRESS, SLOW LOSS OF SUCTION. BABY DELIVERED WITH CEPHALOHAEMATOMA, WENT TO NICU. BABY AND MUM ARE FINE. LOT OLM RECORDED 171117"

  Patient problems: Cephalohematoma

  MAUDE report 7232966 ↗
• InjuryDec 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A CLINICAL SPECIALIST THAT THEY "HAVE HAD 3 INCIDENTS IN THE LAST 6 MONTHS OF BABIES WHO HAVE EITHER BEEN DELIVERED BY VENTOUSE (OMNICUP) WHO HAVE HAD A BLEED BETWEEN THE SKULL AND SKIN WHICH IS KNOWN AS A SUBGALEAL BLEED."

  Patient problems: Hemorrhage, Subgaleal

  MAUDE report 7106728 ↗

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