Cook G19891Recalls & reported problems
Cook Incorporated · Cook, Cervical Ripening Balloon With Stylet · Class 2
Quick summary
This Cook cervical ripening balloon is used to help dilate the cervix before labor. Reports mostly describe balloons developing holes, breaking apart with pieces remaining inside, packaging problems, and bleeding. There are 42 reports that name its identifier, with no deaths and 20 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00827002198913), received between Oct 27, 2017 and Sep 23, 2026 — classified as 21 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 reports).
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 Problem17
- Device Contaminated During Manufacture or Shipping4
- Material Puncture/Hole4
- Material Separation3
- Contamination /Decontamination Problem2
- Device Contamination with Chemical or Other Material2
- Unsealed Device Packaging2
- Use of Device Problem2
Patient problems
- No Code Available14
- No Clinical Signs, Symptoms or Conditions8
- Hemorrhage/Blood Loss/Bleeding6
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient3
- No Patient Involvement3
- Pain2
- Bruise/Contusion1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Use of Device Problem
Patient problems: Pain
MAUDE report 50872384 ↗MalfunctionApr 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21857570 ↗MalfunctionMar 13, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18896276 ↗InjuryFeb 7, 2024
COOK CERVICAL RIPENING BALLOON END BROKE OFF AND THE OTHER PART STAYED IN PATIENT. PATIENT HAD A C-SECTION TO REMOVE THE REST OF THE BALLOON. PATIENT WAS BEING INDUCED AND CATHETER WAS BEING USED PER POLICY/PROTOCOL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18667809 ↗MalfunctionOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Genital Bleeding; Vaginal Mucosa Damage
MAUDE report 17931964 ↗MalfunctionOct 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17907121 ↗MalfunctionJul 20, 2023Unsealed Device Packaging; Unsealed Device Packaging
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17365382 ↗MalfunctionDec 2, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15908271 ↗MalfunctionOct 7, 2022Unsealed Device Packaging; Unsealed Device Packaging
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15565526 ↗InjuryJul 9, 2021Off-Label Use; Off-Label Use
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: Rupture
MAUDE report 12141912 ↗InjuryMay 14, 2021Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11828308 ↗MalfunctionApr 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11604547 ↗MalfunctionSep 29, 2020Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 10598871 ↗InjurySep 24, 2020Material Separation; Material Separation
ADDITIONAL INFORMATION WAS PROVIDED ON 30SEP2020: THE BALLOON WAS REMOVED BY THE PROVIDER DOING A VAGINAL EXAM. IT WAS IN 2 PARTS.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 10579648 ↗MalfunctionJul 31, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT IS REPORTED DURING INCOMING QUALITY CONTROL AT A DISTRIBUTOR, A COOK CERVICAL RIPENING BALLOON W/STYLET WAS FOUND TO HAVE HAIR-LIKE FOREIGN MATTER SEALED IN THE PACKAGE. THIS DEVICE WAS NEVER SHIPPED TO A USER FACILITY OR MADE ANY PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 10349419 ↗MalfunctionJul 27, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10325691 ↗MalfunctionJul 1, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO USE, AN UNKNOWN PIECE OF FOREIGN MATTER WAS FOUND IN THE PACKAGING OF A COOK CERVICAL RIPENING BALLOON W/STYLET. THE ISSUE WAS DISCOVERED BY THE DISTRIBUTOR. A PHOTO WAS RECEIVED, AND IT SHOWS TWO SMALL BLACK DOTS IN THE PACKAGING. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10219011 ↗InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Code Available
MAUDE report 9782305 ↗InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED AFTER INDUCTION OF LABOR AT 40 WEEKS FOR "A BIG BABY" USING A COOK CERVICAL RIPENING BALLOON W/STYLET (CRB), AN UMBILICAL CORD PROLAPSE OCCURRED. PROVIDED DETAILS AND SEQUENCE OF EVENTS AS FOLLOWS: (B)(6) 2019 AT 23:15-CRB WAS PLACED. FETAL POSITION AT TIME OF INSERTION REPORTED AS " LONG CEPHALIC RIGHT OCCIPUT ANTERIOR (ROA) 3/5 PALP", MEMBRANES INTACT. CONFIRMED BY ABDOMINAL PALPATION. VAGINAL EXAM - 2 TO SPINES. MEMBRANES INTACT. CARDIOTOCOGRAPHY (CTG) WAS PERFORMED POST BALLOON PLACEMENT FOR 35 MINUTES (FINDINGS NOT SPECIFIED). (B)(6) 2019 AT 03:15: CTG REPEATED (FINDINGS UNSPECIFIED). 08:15-CTG REPEATED (FINDINGS UNSPECIFIED). 10:15* CRB FELL OUT AFTER BEING INDWELLING FOR 23 HOURS. IT WAS CONFORMED THAT THE CRB DID NOT MALFUNCTION IN ANY WAY. 12:15-CTG REPEATED (FINDINGS UNSPECIFIED) WITH CONTINUOUS MONITORING FOR 2 HOURS 12:25-UNSUCCESSFUL ATTEMPT TO ARTIFICIALLY RUPTURE THE MEMBRANES (FETAL STATION AT THIS TIME UNKNOWN). HAND FELT. ATTENDING PHYSICIAN REVIEW AND ULTRASOUND COMPLETED. CORD SEEN AND VAGINAL EXAM RESULTING IN SPONTANEOUS RUPTURE OF MEMBRANES (SROM) RESULTED IN CORD PROLAPSE. CERVICAL DILATATION AT THE TIME 3CM. THE PATIENT WAS TAKEN TO THE OPERA
Patient problems: No Code Available
MAUDE report 9738785 ↗InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED AFTER INDUCTION OF LABOR USING A COOK CERVICAL RIPENING BALLOON W/STYLET (CRB), AN UMBILICAL CORD PROLAPSE OCCURRED. PROVIDED DETAILS AND SEQUENCE OF EVENTS AS FOLLOWS: ON (B)(6) 2019 AT 11:30: CRB WAS PLACED. FETAL POSITION AT TIME OF INSERTION REPORTED AS "LONG CEPHALIC RIGHT OCCIPUT LATERAL (ROL) 2/5 PALP". VAGINAL EXAM (VE) -3 TO SPINES", MEMBRANES INTACT. CONFIRMED BY ABDOMINAL PALPATION. CARDIOTOCOGRAPHY (CTG) POST BALLOON PLACEMENT (FINDINGS UNSPECIFIED). CTG ASSESSED INTERMITTENTLY AS NORMAL ON 5 OCCASIONS WHILE BALLOON IN SITU. 17:20: CTG (FINDINGS UNSPECIFIED). 21:20: CTG (FINDINGS UNSPECIFIED), TRANSFERRED TO LABOR WARD, CTG CONTINUOUS UNTIL DELIVERY. 21:55: CTG SHOWED DECELERATIONS RELATED TO CONTRACTIONS. ON (B)(6) 2019 AT 00:15: CRB FELL OUT AFTER BEING INDWELLING AROUND 13HOURS. 02:30: THE PATIENT WAS TRANSFERRED TO THE LABOR WARD. CTG SHOWED DECELERATIONS (RATE UNSPECIFIED). REVIEWED BY ATTENDING PHYSICIAN. 03:35: MIDWIFE ATTEMPTED ARTIFICIAL RUPTURE OF MEMBRANES (ARM). FETAL STATION AT TIME OF ARM ATTEMPT POSTERIOR -3 FROM SPINES. 03:38: ARM WAS COMPLETED BY ATTENDING PHYSICIAN. CORD PROLAPSE OCCURRED. 03:46: PATIENT WAS TRANSFERRED TO THE OPERATING
Patient problems: No Code Available
MAUDE report 9712910 ↗InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED AFTER INDUCTION OF LABOR USING A COOK CERVICAL RIPENING BALLOON W/STYLET (CRB), AN UMBILICAL CORD PROLAPSE OCCURRED. PROVIDED DETAILS AND SEQUENCE OF EVENTS AS FOLLOWS: ON (B)(6) 2019 AT 18:05: CRB WAS PLACED. IT WAS DIFFICULT TO INSERT (DIFFICULTY UNSPECIFIED). FETAL POSITION AT TIME OF INSERTION REPORTED AS " LONG CEPHALIC LEFT OCCIPUT POSTERIOR (LOP) 4/5 PALP. VAGINAL EXAM (VE) -2 TO SPINES", MEMBRANES INTACT. CONFIRMED BY ABDOMINAL PALPATION. CARDIOTOCOGRAPHY (CTG) WAS PERFORMED POST BALLOON PLACEMENT (FINDINGS NOT SPECIFIED). 21:45: CTG (FINDINGS UNSPECIFIED). ON (B)(6) 2019 AT 02:00: FETAL HEART RATE HEARD (FINDINGS UNSPECIFIED). 07:30: CRB REMOVED AFTER BEING INDWELLING AROUND 13 HOURS, CTG CONTINUOUS UNTIL DELIVERY. IT IS REPORTED THAT THE CRB DID NOT MALFUNCTION IN ANY WAY. 08:00: CTG REPEATED (FINDINGS UNSPECIFIED). 10:10:* ARTIFICIAL RUPTURE OF MEMBRANES (ARM) WAS PERFORMED, FETAL STATION AT THE TIME OF ARM WAS REPORTED TO BE "-2 FROM SPINES". 10:25*: SYNTOCINON STARTED. 13:30: FETAL HEART RATE HEARD (FINDINGS UNSPECIFIED). 19:00: CTG REPEATED (FINDINGS UNSPECIFIED). 19:30: CTG CONTINUOUS UNTIL DELIVERY. CTG WAS REPORTED TO BE MOSTLY NORMAL UNTIL A PROLONG
Patient problems: No Code Available
MAUDE report 9708940 ↗InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED AFTER INDUCTION OF LABOR USING A COOK CERVICAL RIPENING BALLOON W/ STYLET (CRB), AN UMBILICAL CORD PROLAPSE OCCURRED. PROVIDED DETAILS AND SEQUENCE OF EVENTS AS FOLLOWS: ON (B)(6) 2019 AT 22:45: CRB WAS PLACED. FETAL POSITION AT TIME OF INSERTION REPORTED AS "LONG CEPHALIC LEFT OCCIPUT ANTERIOR (LOA ) 2/5 PALP. VAGINAL EXAM (VE) -2 TO SPINES", MEMBRANES INTACT. CONFIRMED BY ABDOMINAL PALPATION. AT 22:30: CARDIOTOCOGRAPHY (CTG) WAS PERFORMED POST BALLOON PLACEMENT (FINDINGS NOT SPECIFIED). ON (B)(6) 2019 AT 03:00: FETAL HEART TONES HEARD (FINDINGS NOT SPECIFIED), AT 06:46: CTG FOR 30 MINUTES (FINDINGS NOT SPECIFIED), AT 07:40: BALLOON FELL OUT. AFTER BEING INDWELLING AROUND 7 HOURS, AT 07:55: CTG RESTARTED AND WAS CONTINUOUS UNTIL DELIVERY. AT 08:40: VAGINAL EXAM BY ATTENDING PHYSICIAN-CORD FELT, AT 08:44: PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR CATEGORY 1 LOWER SEGMENT CESAREAN SECTION (LSCS), SPINAL ANESTHESIA WAS ADMINISTERED. AT 08:53: BABY WAS BORN IN GOOD CONDITION. IN DOCUMENT PROVIDED BY CUSTOMER, THE TIME OF VAGINAL EXAM IS LISTED AS 09:40. BASED ON THE REMAINING TIMELINE PROVIDED, THIS TIME WAS ASSUMED TO BE 08:40 AND NOT 09:40. VERIFICATION OF THIS
Patient problems: No Code Available
MAUDE report 9708841 ↗InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED AFTER INDUCTION OF LABOR USING A COOK CERVICAL RIPENING BALLOON W/STYLET (CRB), AN UMBILICAL CORD PROLAPSE OCCURRED. PROVIDED DETAILS AND SEQUENCE OF EVENTS AS FOLLOWS: ON (B)(6) 2019 AT 20:10 CRB WAS PLACED. FETAL POSITION AT TIME OF INSERTION REPORTED AS " LONG CEPHALIC LEFT OCCIPUT ANTERIOR (LOA) 3/5 PALP. ", MEMBRANES INTACT. CONFIRMED BY ABDOMINAL PALPATION. CARDIOTOCOGRAPHY (CTG) WAS PERFORMED POST BALLOON PLACEMENT (FINDINGS NOT SPECIFIED). ON (B)(6) 2019 AT 1430: CTG REPEATED (FINDINGS UNSPECIFIED). 14:27: THE CRB WAS REMOVED. IT IS REPORTED THAT THE CRB DID NOT MALFUNCTION IN ANY WAY. 14:37: MOVED TO LABOR WARD AND CONTINUOUS CTG MONITORING UNTIL DELIVERY (FINDINGS NOT SPECIFIED). 14:42: ARTIFICIAL RUPTURE OF MEMBRANES (ARM) WAS PERFORMED, FETAL POSITION/STATION AT TIME OF ARM DESCRIBED AS " -2 TO SPINES, PALPATED CEPHALIC, CORD FELT." 14:44 : THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR CATEGORY 1 LOWER SEGMENT CESAREAN SECTION (LSCS), SPINAL ANESTHESIA WAS ADMINISTERED. 15:14: BABY BORN BREECH IN GOOD CONDITION. NO ADDITIONAL CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL DETAILS REGARDING THE PATIENT/EVENT HAVE BEEN REQUESTED. AT THIS
Patient problems: No Code Available
MAUDE report 9708333 ↗InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED AFTER INDUCTION OF LABOR USING A COOK CERVICAL RIPENING BALLOON W/STYLET (CRB), AN UMBILICAL CORD PROLAPSE OCCURRED. PROVIDED DETAILS AND SEQUENCE OF EVENTS AS FOLLOWS: ON (B)(6) 2019 AT 11:50: CRB WAS PLACED. FETAL POSITION AT TIME OF INSERTION REPORTED AS " LONG CEPHALIC LEFT OCCIPUT ANTERIOR (LOA) 2/5 PALP", MEMBRANES INTACT. CONFIRMED BY ABDOMINAL PALPATION. CARDIOTOCOGRAPHY (CTG) WAS PERFORMED POST BALLOON PLACEMENT (FINDINGS NOT SPECIFIED). ON (B)(6) 2019 AT 02:30: CTG REPEATED (FINDINGS UNSPECIFIED) AT AN UNSPECIFIED TIME, THE PATIENT WAS MOVED TO THE LABOR WARD AND CTG WAS CONTINUOUS UNTIL DELIVERY. 04:00: THE CRB WAS REMOVED AFTER BEING INDWELLING FOR 17 HOURS. IT IS REPORTED THAT THE CRB DID NOT MALFUNCTION IN ANY WAY. 04:08: ARTIFICIAL RUPTURE OF MEMBRANES (ARM) WAS PERFORMED, AND THE CORD WAS FELT. FETAL POSITION/STATION AT THE TIME OF ARM ARE UNKNOWN. CTG WAS IN PROGRESS AND NORMAL (CONFIRMED BY ATTENDING PHYSICIAN). 04:40: THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR CATEGORY 2 LOWER SEGMENT CESAREAN SECTION (LSCS), SPINAL ANESTHESIA WAS ADMINISTERED. 05:08: BABY BORN IN GOOD CONDITION. NO ADDITIONAL CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTE
Patient problems: No Code Available
MAUDE report 9707827 ↗InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: Death, Intrauterine Fetal
MAUDE report 9673045 ↗
Other Catheter, balloon, dilation of cervical canal prior to labor devices
- Cook G48149Cook Incorporated · Catheter, balloon, dilation of cervical canal prior to labor15 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.