Mityvac 10137Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888937003093), received between Dec 9, 2019 and Feb 20, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2023Mechanical Problem; Mechanical Problem

  PER DETAILS ON INCOMING (B)(4). VACUUM CUP PIPE BENDS AND VACUUM DOES NOT OCCUR. USE OF AN ALTERNATIVE DEVICE (FORCEPS) IN A COMPLICATED DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403161 ↗
• MalfunctionMay 10, 2021Leak/Splash

  REPORT STATED "LEAKAGE PROBLEM". M-SELECT MUSHROOM 10137 (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11797854 ↗
• MalfunctionMay 7, 2021Crack

  REPORT STATED "THE SUCTION CUP CRACKED DURING USE". PER ADDITIONAL INFORMATION- THE SUCTION CUP REF 199 07 01 CRACKED DURING A DELIVERY AND SHE HAD TO USE ANOTHER SUCTION CUP" . END-USER FURTHER STATED- "THE PHARMACIST CALLS, SHE EXPLAINS ME THAT SHE HAD SENT A DECLARATION OF A CASE OF MATERIALOVIGILANCE, CONCERNING AN OBSTETRICAL SUCTION CUP TO THE E-MAIL ADDRESS (CONTACT CCD) ON 08/03 BUT THAT SHE DID NOT HAVE ANY RETURN SINCE. THIS CONCERNS A VACUUM CUP THAT MELTED WHEN USED DURING THE DELIVERY. THE VACUUM COULD NOT BE DONE. THE STAFF HAD CHANGED THE SUCTION CUP. THE SUCTION CUP CONCERNED IS AT THE PHARMACY, IF THE LABORATORY WISHES TO RECOVER IT. THE PHARMACIST WOULD LIKE TO HAVE AN EXCHANGE. NO DIRECT IMPACT ON THE PATIENT, JUST A DELAY IN MANAGEMENT. M-SELECT MUSHROOM 10137. E-COMPLAINT- (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11791577 ↗
• MalfunctionDec 9, 2019Material Separation; Gas/Air Leak

  REPORT STATED " CUP SPLIT AT SITE WHERE IT MEETS THE CONNECTION TUBING". FURTHER DETAILS - M-SELECT MUSHROOM VACUUM-ASSIST DELIVERY CUP APPLIED AT THE FLEXION POINT BELOW THE POSTERIOR FONTANELLE. POSITION CHECKED AND PRESSURE INCREASED TO 20 CMHG. APPLICATION RECHECKED AND PRESSURE INCREASED TO 80 CMHG. GENTLE TRACTION WAS APPLIED AND BABY'S HEAD ROTATED. CUP DETACHED AFTER THE SECOND PULL AND LOSS OF SUCTION NOTED DURING THAT PULL. CUP REATTACHED AND POSITION OF CUP RECHECKED. AIR LEAK HEARD AND LACK OF ADEQUATE SUCTION NOTED BY THE REGISTRAR CONDUCTING THE DELIVERY. CUP REMOVED AND SPLIT SEEN BY THE REGISTRAR. 1216677-2019-00312-1 M-SELECT MUSHROOM 10137 (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9437079 ↗