Mystic 10057Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888937003109), received between Oct 11, 2018 and Jul 12, 2021 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

4 other recalls cover devices cleared under the same FDA submission (K011532); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2021Break

  DURING THE PROCEDURE THE PRODUCT BROKE. 1216677-2021-00144 MYSTIC II, MUSHROOM CUP 10057 (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12150922 ↗
• MalfunctionJun 4, 2021Break

  "(B)(6) CALLED TO REPORT THAT MYSTIC MUSHROOM BROKE DURING DELIVERY PROCESS THEY REPLACED WITH ANOTHER ONE. DOES NOT HAVE PRODUCT WAS THROWN OUT AND THIS OCCURED ON (B)(6) 2021 AND WAS REPORTED TODAY". MYSTIC II,MUSHROOM CUP 10057. E-COMPLAINT- (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11940097 ↗
• MalfunctionMay 7, 2021Material Rupture

  REPORT STATED - RUPTURE OF THE SUCTION CUP. MYSTIC II,MUSHROOM CUP 10057 (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11792949 ↗
• MalfunctionMay 7, 2021Break

  MULTIPLE REPORT SUBMITTED BY SUPPLIER/DISTRIBUTOR - PER REPORT - BREAKAGE DURING USE. MYSTIC II MUSHROOM CUP 10057 E-COMPLAINT-(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11792264 ↗
• MalfunctionMay 25, 2020Break

  MEDWATCH FORM_UF_IMPORTER REPORT #-(B)(4) - AND MEDWATCH 5094030. A MUSHROOM VACUUM INSTRUMENT BROKE DURING AN INSTRUMENT ASSISTED DELIVERY. DETAILS PROVIDED BY THE DELIVERY NOTE STATED " A TOTAL OF 3 PULLS WERE PERFORMED AND 2 POPOFFS OCCURRED. TWO REAPPLICATIONS WERE PERFORMED WITH THE THIRD PULL, THE MUSHROOM VACUUM HANDLE BROKE WITH CUP LEFT ON THE FETAL HEAD WHICH WAS REMOVED. THE FETAL HEAD HAD MADE DESCENT. AFTER THE VACUUM BROKE, PUSH CONTINUED WITH MATERNAL EXPULSIVE EFFORTS WITH CONTRACTION" NO HARM TO PATIENT AND NEW BORN. (B)(4). 1216677-2020-00123 MYSTIC II MUSHROOM CUP 10057 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10085676 ↗
• MalfunctionMay 25, 2020Break

  MEDWATCH FORM_UF_IMPORTER REPORT #-(B)(4)- AND MEDWATCH5094030. A MUSHROOM VACUUM INSTRUMENT BROKE DURING AN INSTRUMENT ASSISTED DELIVERY. DETAILS PROVIDED BY THE DELIVERY NOTE STATED " A TOTAL OF 3 PULLS WERE PERFORMED AND 2 POPOFFS OCCURRED. TWO REAPPLICATIONS WERE PERFORMED WITH THE THIRD PULL, THE MUSHROOM VACUUM HANDLE BROKE WITH CUP LEFT ON THE FETAL HEAD WHICH WAS REMOVED. THE FETAL HEAD HAD MADE DESCENT. AFTER THE VACUUM BROKE, PUSH CONTINUED WITH MATERNAL EXPULSIVE EFFORTS WITH CONTRACTION" NO HARM TO PATIENT AND NEW BORN. (B)(4). 1216677-2020-00124 MYSTIC II MUSHROOM CUP (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10085670 ↗
• MalfunctionApr 23, 2020Break

  MEDWATCH FORM_UF_IMPORTER REPORT #-(B)(4)- A MUSHROOM VACUUM INSTRUMENT BROKE DURING AN INSTRUMENT ASSISTED DELIVERY. DETAILS PROVIDED BY THE DELIVERY NOTE STATED " A TOTAL OF 3 PULLS WERE PERFORMED ND 2 POPOFFS OCCURRED. TWO REAPPLICATIONS WERE PERFORMED WITH THE THIRD PULL, THE MUSHROOM VACUUM HANDLE BROKE WITH CUP LEFT ON THE FETAL HEAD WHICH WAS REMOVED. THE FETAL HEAD HAD MADE DESCENT. AFTER THE VACUUM BROKE, PUSH CONTINUED WITH MATERNAL EXPULSIVE EFFORTS WITH CONTRACTION" NO HARM TO PATIENT AND NEW BORN. REF: (B)(4). 1216677-2020-00097 MYSTIC II MUSHROOM CUP 10057 (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9993688 ↗
• MalfunctionApr 23, 2020Break; Material Split, Cut or Torn

  THE PATIENT WAS PLACED IN THE LITHOTOMY POSITION. WHEN PULLED SECOND TIME, THE TUBE WAS TORN OFF. DETAIL TO PROCEDURE STATED "WHEN THE TUBE'S EDGE BROKE, THE PHYSICIAN'S RIGHT HAND HOLDS THE HANDLE WITH HER LEFT HAND PLACED. THE PRODUCT WAS VERTICAL TO THE HEAD OF INFANT WHEN THE INCIDENT OCCURRED." PATIENT REPORTED TO EXPERIENCE BLEEDING AND BABY WAS DELIVERED BY FORCEPS METHOD, NOT BY VACUUM EXTRACTION. MYSTIC II MUSHROOM CUP 10057 (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9993433 ↗
• MalfunctionApr 16, 2020Suction Failure

  "MD AND ORT C/O VACUUM WOULD NOT HOLD SUCTION". ADDITIONAL INFORMATION: "THE PHYSICIAN USED FORCEPS INSTEAD OF VACUUM DUE TO THE VACUUM NOT HOLDING SUCTION. TECH REPORTED IT WOULD NOT PUMP TO GREEN IN ORDER TO OBTAIN SUCTION". 10057 MYSTIC II MUSHROOM CUP (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9969824 ↗
• MalfunctionMar 31, 2020Break

  A MUSHROOM VACUUM INSTRUMENT BROKE DURING AN INSTRUMENT-ASSISTED DELIVERY. DETAILS PROVIDED FROM DELIVERY NOTE: " A TOTAL OF 3 PULLS WERE PERFORMED, AND 2 POPOFFS OCCURRED. TWO REAPPLICATIONS WERE PERFORMED. WITH THE THIRD PULL, THE MUSHROOM VACUUM HANDLE BROKE, WITH CUP LEFT ON THE FETAL HEAD, WHICH WAS REMOVED. THE FETAL HEAD HAD MADE SOME DESCENT. AFTER THE VACUUM BROKE, PUSHING CONTINUED WITH JUST MATERNAL EXPULSIVE EFFORTS WITH CONTRACTIONS." NO HARM CAME TO THE PATIENT OR NEWBORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9902792 ↗
• MalfunctionMar 5, 2020Break

  INCIDENT DETAILS SURROUNDING EVENT: 10057 WAS USED BECAUSE OF ASFYCSIA. CUP BREAK DOWN AT ONCE WITH VERY LIGHT TRACTION. CUSTOMER TOOK KIWI CUP AND ALL WENT WELL. REF : E-COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9793829 ↗
• MalfunctionNov 26, 2019Break

  THE CUP BROKE FROM THE TUBING, AND THE GYNECOLOGIST FELL. WE PHONED THE PHARMACIST TO HAVE MORE INFORMATION ABOUT THIS, AND HE SAID THAT IT WAS THE THIRD TIME IN 10 DAYS WITH 3 DIFFERENT GYNECOLOGISTS ON 3 DIFFERENT OPERATIONS THAT THE CUP BROKE FROM THE TUBING. AND ALL THE CUP ARE FROM BATCH 254343. THERE WERE NO MAJOR CLINICAL CONSEQUENCES FOR EACH CASE. 1216677-2019-00308-1 MYSTIC II MUSHROOM CUP 10057 (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9378727 ↗
• MalfunctionNov 26, 2019Break

  THE CUP BROKE FROM THE TUBING, AND THE GYNECOLOGIST FELL. WE PHONED THE PHARMACIST TO HAVE MORE INFORMATION ABOUT THIS, AND HE SAID THAT IT WAS THE THIRD TIME IN 10 DAYS WITH 3 DIFFERENT GYNECOLOGISTS ON 3 DIFFERENT OPERATIONS THAT THE CUP BROKE FROM THE TUBBING. AND ALL THE CUP ARE FROM BATCH 254343. THERE WERE NO MAJOR CLINICAL CONSEQUENCES FOR EACH CASE. MYSTIC II MUSHROOM CUP 10057 (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9378638 ↗
• MalfunctionNov 26, 2019Break

  THE CUP BROKE FROM THE TUBING, AND THE GYNECOLOGIST FELL. WE PHONED THE PHARMACIST TO HAVE MORE INFORMATION ABOUT THIS, AND HE SAID THAT IT WAS THE THIRD TIME IN 10 DAYS WITH 3 DIFFERENT GYNECOLOGISTS ON 3 DIFFERENT OPERATIONS THAT THE CUP BROKE FROM THE TUBING. AND ALL THE CUP ARE FROM BATCH 254343. THERE WERE NO MAJOR CLINICAL CONSEQUENCES FOR EACH CASE. MYSTIC II MUSHROOM CUP 10057, E-COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9378469 ↗
• MalfunctionMar 15, 2019Therapeutic or Diagnostic Output Failure

  WE TRY TO USE SUCTION CUP DURING AN EMERGENCY CESAREAN SECTION, THE PRODUCT WAS NOT FUNCTIONAL. (POSTPONEMENT OF THE INTERVENTION, PROLONGATION OF HOSPITALIZATION, LOSS OF TRANSIENT FUNCTION) WIDESPREAD DISORGANIZATION, MALFUNCTION OF THE SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8424635 ↗
• MalfunctionNov 14, 2018Break

  CUSTOMER STATED "ONE OF OUR CUSTOMERS RETURNED A BATCH OF (B)(4), 10057 MYSTIC II PUMP W/MUSHROOM CUP, BATCH N° 230218. (B)(4) WERE COMPLETELY BROKEN WHILE DELIVERING THE BABY, SO WE REPLACED THEM IMMEDIATELY TO SATISFY CUSTOMER. (B)(4) OF THE SAME BATCH WERE RETURNED BY THE SAME CUSTOMER AS THEY DOESN'T TRUST THE QUALITY OF THEM." 1216677-2018-00071-1 MYSTIC II MUSHROOM CUP 10057 E-COMPLAINT-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8070352 ↗
• MalfunctionOct 15, 2018Activation, Positioning or Separation Problem

  "CUP DID NOT RELEASE WHEN PHYSICIAN APPLIED RELEASE LEVER , A MANUAL REMOVAL OF CUP FROM HEAD WAS DONE, BABY WAS IN OP POSITION." (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7964864 ↗
• MalfunctionOct 12, 2018Break; Detachment of Device or Device Component

  PRESSURE RELEASE VALVE WAS SQUEEZED AND IT DID NOT RELEASE PRESSURE AND IT BROKE OFF SNAPPED IN TWO. MD MANUALLY REMOVED THE CUP FROM THE NEWBORN'S HEAD. IT RELEASED EASILY." (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7961648 ↗
• MalfunctionOct 11, 2018Material Deformation

  "THERE IS A DEPRESSION OF THE CUP. AND THE CUP DOES NOT HOLD. THEY HAVE TO RESET THE PRESSURE." (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7955977 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011532. One submission often covers many models, so check the product and lot details in each record.

• Z-1888-2008 · Jan 16, 2008 · Terminated
  M-Style Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted Delivery System (Ref: 10015LP). Product is intended to assist a clinician in the delivery o
• Z-1887-2008 · Jan 16, 2008 · Terminated
  M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an infant during childbirth
• Z-1889-2008 · Jan 16, 2008 · Terminated
  Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated f
• Z-0005-05 · Aug 17, 2004 · Terminated
  Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047