Mityvac 10007LPRecalls & reported problems
Coopersurgical, Inc. · M-Style Mushroom Cup Vacuum-Assist Delivery System · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937003048), received between Mar 15, 2019 and Mar 15, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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.
Most reported problems
Device problems
- Material Rupture1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2019Material Rupture
I WOULD LIKE TO REPORT THAT THE CUP WAS RUPTURED DURING VACUUM DELIVERY OPERATION. THE DEVICE WAS CHANGED TO THE NEW ONE, THEN PROCEDURE WAS COMPLETED. BABY HAD A ABRASION ON HEAD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8424990 ↗
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.
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