MityOne 10068Recalls & reported problems
Coopersurgical, Inc. · Pump with MitySoft Bell Cup · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937003130), received between Apr 12, 2021 and Jan 27, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Pumping Problem” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Pumping Problem1
- Use of Device Problem1
Patient problems
- Abrasion1
- Bruise/Contusion1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A MITYONE MUSHROOM CUP WAS TO ASSIST WITH DELIVERY ON (B)(6) 2025. THE TOTAL VACUUM APPLICATION TIME WAS ONE MINUTE, WITH FOUR VACUUM PULLS AND ONE POP OFF. DELIVERY HAD TO BE COMPLETED VIA C-SECTION. INFANT SUSTAINED SCALP ABRASIONS AND BRUISING. NO ADDITIONAL INFORMATION IS AVAILABLE. 10068 MITYONE (B)(4).
Patient problems: Abrasion; Bruise/Contusion
MAUDE report 21244226 ↗MalfunctionApr 12, 2021Use of Device Problem; Pumping Problem
DURING THE PROCEDURE, THE PUMP CANNOT REACH 40CMHG. 1.ANY SIGNIFICANT DELAY AS A RESULT OF THE REPORTED CONDITION? THERE WAS PROBABLY A COUPLE OF CONTRACTIONS DELAY - SO ABOUT 3-5 MINUTES. 2.DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE / HOW WAS THE PROCEDURE COMPLETED? THE OB REQUESTED TO BRING FORCEPS. IN THE END, THE BIRTH WAS COMPLETE WITH REAPPLICATION - MINIMAL SUCTION PRESSURE - NOT EVEN THE GREEN ZONE AND COACHED MATERNAL INCREASED EFFORT WITH. THE POP-OFF WOULD HAPPEN WITH THE REGULAR PULL, BUT THE MINIMAL PULL AND MATERNAL PUSH OVER A FEW MORE CONTRACTIONS (WITH POP OFFS) BROUGHT THE FETAL HEAD DOWN AND THEN THE OB WAS ABLE TO COMPLETE THE DELIVERY. MITYONE BELL CUP 10068 (B)(4).
Patient problems: Insufficient Information
MAUDE report 11651659 ↗
Other Extractor, Vacuum, Fetal devices
- Kiwi® OmniCup® VAC-6000MTEClinical Innovations, LLC · Extractor, Vacuum, Fetal1 recall1 death20 reports
- Kiwi® OmniCup® VAC-6000MTClinical Innovations, LLC · Extractor, Vacuum, Fetal1 recall1 death7 reports
- Mystic 10057Coopersurgical, Inc. · Extractor, Vacuum, Fetal19 reports
- Kiwi® OmniCup® VAC-6000MClinical Innovations, LLC · Extractor, Vacuum, Fetal14 reports
- Kiwi® OmniCup® VAC-6000MEClinical Innovations, LLC · Extractor, Vacuum, Fetal10 reports
- MityOne 10067Coopersurgical, Inc. · Extractor, Vacuum, Fetal10 reports
- Mityvac 10137Coopersurgical, Inc. · Extractor, Vacuum, Fetal4 reports
- Kiwi® ProCup® VAC-6000SClinical Innovations, LLC · Extractor, Vacuum, Fetal3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page