Cook G48149Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002481497), received between Jul 18, 2016 and Apr 28, 2025 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 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 21918067 ↗
• InjuryMar 26, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Fever

  MAUDE report 18980907 ↗
• InjuryMar 18, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED, A PATIENT DEVELOPED A FEVER FOLLOWING THE USE OF A 'COOK CERVICAL RIPENING BALLOON'. UPON REMOVAL FROM THE PACKAGE, NO DAMAGE TO THE DEVICE WAS NOTED. THE NURSE WAS ABLE TO PLACE THE DEVICE IN 3-5 MINUTES. AFTER THE DEVICE WAS INDWELLING 12-14 HOURS, IT WAS NOTED THAT THE PATIENT DEVELOPED A FEVER. THE DEVICE WAS REMOVED, AND ARTIFICIAL RUPTURE OF MEMBRANES (AROM) WAS PERFORMED AND OXYTOCIN WAS ADMINISTERED. THE PATIENTS HEMOGRAM (CBC) TEST WAS FOUND TO BE ELEVATED AND IT WAS DECIDED THAT THE PATIENT WOULD BE CONVERTED FROM VAGINAL DELIVERY TO CESAREAN SECTION. THE PATIENT'S FEVER WAS TREATED WITH ANTIBIOTICS. THE PATIENT WAS NOT CULTURED TO DETERMINE THE CAUSE OF THE FEVER.

  Patient problems: Fever

  MAUDE report 18925006 ↗
• MalfunctionOct 10, 2023Contamination; Delivered as Unsterile Product; Contamination; Delivered as Unsterile Product

  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 17907072 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, ON (B)(6) 2023, A PREGNANT, FEMALE, PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO TERM PREGNANCY (40+1) AND HIGH BLOOD PRESSURE (PREECLAMPSIA). THE PATIENT WAS EXAMINED AND FOUND TO HAVE AN IMMATURE CERVIX WITH A BISHOP SCORE OF 2. ON (B)(6) 2023, THE USER SUCCESSFULLY PLACED A 'COOK CERVICAL RIPENING BALLOON'; THE PATIENT DID NOT REPORT ANY DISCOMFORT DURING DEVICE PLACEMENT. ON (B)(6) 2023 AT 0950, APPROXIMATELY 17 HOURS AFTER PLACEMENT, THE USER REMOVED THE DEVICE AND THEN ARTIFICIALLY RUPTURED THE MEMBRANES (AROM). APPROXIMATELY 8 HOURS LATER, AT 1745, IT WAS NOTED THAT THE PATIENTS FETAL MONITORING WAS UNFAVORABLE AND THE DOCTOR SUSPECTED INTRAUTERINE FETAL DISTRESS (IUFD); THE PATIENT WAS EXAMINED AND IT WAS DETERMINED THAT AN EMERGENCY CESAREAN SECTION WAS INDICATED. THE PATIENT'S TEMPERATURE WAS ASSESSED AND FOUND TO BE 38.6 (101.5°F); THE PATIENT ALSO APPEARED COLD AND CHILLED. AT 2030, THE PATIENT SUCCESSFULLY DELIVERED THE FETUS VIA CESAREAN SECTION. 'CEFOPERAZONE' AND 'SULBACTAM' 2G WAS ADMINISTERED EVERY 8 HOURS FOR 3 DAYS POST-OP; AFTER 3 DAYS OF CONTINUOUS ANTI-INFECTION TREATMENT, THE HIGH FEVER WAS RESOLVED. AT 4 DAYS POST-OP, 'MEROPENEM' 1G WAS ADMINIST

  Patient problems: Fever; Unspecified Infection

  MAUDE report 17733057 ↗
• MalfunctionFeb 20, 2023Inflation Problem; Device Contaminated During Manufacture or Shipping; Inflation Problem; Device Contaminated During Manufacture or Shipping

  AS REPORTED, UNABLE TO INJECT WATER INTO A COOK® CERVICAL RIPENING BALLOON. THERE WAS NO EVIDENCE OF A LEAK. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. UPON INSPECTION OF THE RETURNED DEVICE, A LARGE WHITE PIECE OF CRYSTALLIZED FOREIGN MATTER WAS PRESENT INSIDE THE UTERINE BALLOON. THE DEVICE WAS FUNCTION TESTED BY INFLATING THE BALLOONS WITH WATER. THE UTERINE BALLOON WAS ABLE TO BE INFLATED, AND THE FOREIGN MATTER INSIDE DISSOLVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406349 ↗
• MalfunctionOct 13, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, A "FOREIGN MATTER LIKE FIBER" WAS FOUND IN THE INNER PACKAGING OF A COOK® CERVICAL RIPENING BALLOON. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE ISSUE WITH THIS DEVICE WAS DISCOVERED PRIOR TO MAKING CONTACT WITH THE PATIENT AND IT WAS NOT USED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595239 ↗
• MalfunctionApr 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION WAS RECEIVED 12APR2021: THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT FROM A DIFFERENT LOT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604806 ↗
• InjuryJul 12, 2018Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem; Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CERVICAL RIPENING BALLOON, WHICH WE USE FOR A MECHANICAL BALLOON INDUCTION, WAS INSERTED IN A PREGNANT PATIENT AND 4 HOURS AFTER INSERTION (2 HOURS AFTER IT WAS REMOVED) THERE WAS A CORD PROLAPSE AND THE FETUS DIED. "THE MANUFACTURER¿S INSTRUCTIONS ARE UNHELPFUL AS THEY ONLY CONTRAINDICATE IT IF THE HEAD IS ¿ABOVE THE PELVIC INLET¿ NOR DOES THE MANUFACTURER LIST CORD PROLAPSE AS A RISK." PER THE INSTRUCTIONS FOR USE (IFU): INTENDED USE: THE CERVICAL BALLOON IS INDICATED FOR MECHANICAL DILATION OF THE CERVICAL CANAL PRIOR TO LABOR INDUCTION AT TERM WHEN THE CERVIX IS UNFAVORABLE FOR INDUCTION. CONTRAINDICATIONS: (...) TRANSVERSE FETAL ORIENTATION, PROLAPSED UMBILICAL CORD, (...) BREECH PRESENTATION, (...) PRESENTATION ABOVE THE PELVIC INLET, (....) WARNINGS: (...) IF SPONTANEOUS RUPTURE OF MEMBRANES OCCURS WHILE THE CERVICAL BALLOON IS IN PLACE, THERE IS A RISK THAT THE UTERINE BALLOON COULD BECOME ENTANGLED IN THE UMBILICAL CORD, NECESSITATING EMERGENT CESAREAN DELIVERY. REQUESTS WERE MADE FOR ADDITIONAL INFORMATION ON 19JUN2018, 21JUN2018, 26JUN2018, AND AN ONSITE VISIT 05JUL2018 INCLUDING THE QUESTIONS LISTED BELOW. THE CUSTOMER HAS NOT PROVIDED ANY FURTHER INFO

  Patient problems: Death, Intrauterine Fetal

  MAUDE report 7683564 ↗
• InjuryJan 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A LABOR INDUCTION PROCEDURE, A COOK® CERVICAL RIPENING BALLOON WAS USED ON THE PATIENT. THE PHYSICIAN USED A SPECULUM TO GAIN CERVICAL ACCESS AND THEN CLEANED THE PATIENT'S CERVIX WITH CLEANING SOLUTION TO PREPARE FOR DEVICE INSERTION. THE PHYSICIAN INSERTED THE CERVIX AND BOTH BALLOONS ENTERED THE CERVICAL CANAL. THE PHYSICIAN INFLATED THE UTERINE BALLOON WITH 40 ML OF NORMAL SALINE AND THE DEVICE WAS PULLED BACK AGAINST THE INTERNAL CERVICAL OS. THE VAGINAL BALLOON WAS THEN INFLATED WITH 20 ML OF SALINE. THE PHYSICIAN ADDED MORE FLUID TO EACH BALLOON IN TURN, IN 20 ML INCREMENTS UNTIL THE UTERINE BALLOON AND VAGINAL BALLOON CONTAINED 80 ML OF SALINE. THE PHYSICIAN LATER REMOVED THE DEVICE FROM THE PATIENT. THE PATIENT HAD A POSTOPERATIVE FEVER AFTER AND WAS AT A TEMPERATURE OF 37.2°. BY ACTIVE TREATMENT SYMPTOM RELIEF, THE PATIENT WAS RETURNED TO NORMAL CONDITION. THE PATIENT HAS SINCE RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS OCCURREN

  Patient problems: Fever

  MAUDE report 7172118 ↗
• MalfunctionDec 4, 2017Material Separation; Material Separation

  THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2017 AND WAS ADMINISTERED PITOCIN. A COOK® CERVICAL RIPENING BALLOON WAS PLACED IN A PATIENT AND AT SOME TIME LATER THE PATIENT USED THE RESTROOM AND THE DEVICE FELL OUT. THE NURSE CHECKED THE DEVICE AT THAT TIME BUT DID NOT REALIZE THAT ONE BALLOON WAS MISSING ON THE DEVICE. ON (B)(6) 2017, THE PATIENT UNDERWENT A C-SECTION AND THE PHYSICIAN FOUND THE BALLOON WITHIN THE PATIENT'S UTERUS; THE BALLOON WAS STILL INFLATED. THE PHYSICIAN REMOVED THE BALLOON AND CONFIRMED THAT NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THERE WERE NO ADVERSE EFFECT TO THE PATIENT RESULTING FROM THIS REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7081646 ↗
• MalfunctionSep 13, 2016Material Rupture; Material Rupture

  DURING A LABOR INDUCTION PROCEDURE, THE UTERUS BALLOON BURST AT 80 ML WHEN INJECTING SALINE. THE BALLOON REPORTEDLY BURST IN A CIRCUMFERENTIAL DIRECTION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5945077 ↗
• MalfunctionAug 29, 2016Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A 39 WEEK LABOR INDUCTION, THE PHYSICIAN INJECTED 40 ML SALINE INTO THE UTERUS AND CERVICAL BALLOONS. REPORTEDLY DURING THE THIRD ROUND THE CERVICAL BALLOON RUPTURED CIRCUMFERENTIALLY WHEN INJECTING 50 ML OF SALINE INTO THE BALLOON. THE PHYSICIAN REMOVED THE RUPTURED BALLOON AND REPLACED WITH A NEW BALLOON. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5910201 ↗
• MalfunctionJul 19, 2016Material Rupture; Material Rupture

  VAGINA BALLOON WAS GOOD WHEN INJECTED WITH 20ML OF SALINE, BUT AFTER CONTINUING TO INJECT 10ML OF SALINE THE BALLOON RUPTURED AND LEAKED. UPDATED INFORMATION FROM THE REP 28JUNE2016: THE BALLOON RUPTURED CIRCUMFERENTIALLY WHILE WITHIN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5802595 ↗
• MalfunctionJul 18, 2016Material Rupture; Material Rupture

  THE INITIAL INFORMATION PROVIDED STATED THAT THE BALLOON WAS BROKEN AND LEAKING WHEN INJECTING 20ML SALINE. UPON RECEIPT OF THE PRODUCT, IT WAS NOTED THE BALLOON HAD RUPTURED IN A CIRCUMFERENTIAL DIRECTION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5802373 ↗