Bakri G24237Recalls & reported problems

Summary

The FDA's MAUDE database contains 229 adverse event reports that list this exact device (DI 10827002242378), received between Jun 28, 2016 and Jan 7, 2026 — classified as 49 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (114 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 25 most recent of 229 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026

  DURING A C- SECTION A BAKRI PLACEMENT WAS ATTEMPTED BUT STAFF WAS UNABLE TO DRAW BACK FLUID FROM THE BAG INTO THE SYRINGE TO FILL THE BALLOON. MULTIPLE STAFF TROUBLESHOOTED WITH NO SUCCESS. EVENTUALLY ANOTHER BAKRI WAS OPENED AND PLACED WITHOUT INCIDENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989297 ↗
• MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING TREATMENT OF POSTPARTUM HEMORRHAGE (PPH), A LEAK WAS FOUND AT THE ANTERIOR END OF 'COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS'. THE PACKAGING WAS INSPECTED AND THE BALLOON WAS PREPARED FOR TRANSABDOMINAL PLACEMENT DURING CESAREAN SECTION IN A LABORING PATIENT WITH WEAK CONTRACTIONS AND BLEEDING OF 400 ML. THE ISSUE WAS FOUND WHEN SALINE WAS INJECTED TO CHECK THE INTEGRITY OF THE BALLOON BEFORE PLACEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER BALLOON. REPORTEDLY, THE PATIENT'S TOTAL BLEEDING WAS 500 ML POSTOPERATIVELY AND NO BLOOD TRANSFUSION WAS PERFORMED. THE PATIENT'S FINAL HEMOSTASIS WAS SUCCESSFUL. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850364 ↗
• MalfunctionJan 23, 2025Material Rupture; Material Rupture

  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 21222282 ↗
• MalfunctionJan 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE, A COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS HAD A SMALL HOLE. SALINE SOLUTION WAS NOTED LEAKING OUT. THE BALLOON WAS PLACED BY A GYNECOLOGIST WHEN THE ISSUE WAS OBSERVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21198733 ↗
• MalfunctionJan 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE USER FOUND THE 'COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS' WAS BROKEN DURING REMOVAL IN THE INTENSIVE CARE UNIT. AS REPORTED, THE FLUID REMOVAL WAS STARTED BUT AN EXIT WAS NOT ACHIEVED. UPON COMPLETE REMOVAL AND INSPECTION OF THE BALLOON, IT WAS FOUND THAT THE DEVICE WAS BROKEN. AS REPORTED, THE DEVICE WAS INSIDE THE UTERINE CAVITY FOR 24 HOURS. AFTER THIS TIME, THE BALLOON WAS REMOVED BECAUSE NO SALINE SOLUTION CAME OUT. THE DEVICE HAD PERFORMED HEMOSTASIS EFFECTIVELY, AS NO RESIDUAL BLEEDING WAS REPORTED IN THE PATIENT AFTERWARD. AS REPORTED, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066343 ↗
• InjuryDec 6, 2024Material Rupture; Material Rupture

  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 20863413 ↗
• MalfunctionNov 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THAT AFTER CHILDBIRTH, THE PATIENT BLOOD LOSS WAS ABOUT 600 ML. THE SURGEON PLACED TRANSABDOMINALLY A COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS AFTER CESAREAN SECTION AS TREATMENT OF POSTPARTUM HEMORRHAGE [PPH]. THE UTERINE DRAINAGE TUBE WAS FOUND TO FLOW FLUID OF LIGHT PINK COLOR, REPORTED TO THE DOCTOR, AT 03:30 REMOVAL OF THE BALLOON, INSPECTION OF THE BALLOON FOUND THAT THE BALLOON HAD LEAKAGE. A NEW SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE BALLOON WAS PLACED WITHOUT FILLING IT WITH LIQUID, BEFORE SUTURING. THE RESULTING IMPACT ON THE PATIENT WAS THAT THE HEMOSTATIC TIME WAS TOO SHORT, AND THE BALLOON WAS NOT FULLY UTILIZED TO STOP THE BLEEDING AND 50 ML OF ADDITIONAL BLOOD LOSS OCCURRED AFTER THE DEVICE FAILURE. THE TOTAL ESTIMATED BLOOD LOSS (EBL) WERE 650 ML. THE BALLOON WAS HANDLED BY OR IN THE PROXIMITY OF SUTURE NEEDLES. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748910 ↗
• InjuryNov 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  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 20736349 ↗
• MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS LEAKED. THE DEVICE WAS PLACED BY THE OBSTETRICS (OB) PHYSICIAN FOR UTERINE BLEEDING AND WAS INFLATED WITH 240 ML OF NORMAL SALINE. ONE IODINE SOAKED VAGINAL PACK WAS ALSO PLACED. LATER THAT DAY, THE VAGINAL PACKING AND BAKRI WERE REMOVED. DURING REMOVAL OF THE BAKRI, ABOUT 10 ML OF FLUID WAS REMOVED FROM THE BALLOON; HOWEVER, RESISTANCE WAS MET AND NO ADDITIONAL FLUID COULD BE REMOVED. THE BAKRI WAS GENTLY PULLED AND WAS SUCCESSFULLY REMOVED WITHOUT DIFFICULTY. IT WAS NOTED THAT THE BEDDING UNDER THE PATIENT WAS SATURATED WITH CLEAR AND LIGHT PINK DRAINAGE. AFTER REMOVAL, REINFLATION OF THE BAKRI BALLOON WAS ATTEMPTED, AND A SMALL HOLE WAS FOUND IN THE BALLOON. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Insufficient Information

  MAUDE report 20568147 ↗
• MalfunctionOct 29, 2024

  REPEAT C-SECTION. BAKRI PLACED BY PHYSICIAN. NORMAL SALINE USED TO FILL THE BAKRI BALLOON. THERE WAS A POP AND BLOOD TINGED FLUID EXITED THE VAGINA. IT WAS DETERMINED THAT THE BAKRI HAD RUPTURED. THE BAKRI WAS REMOVED FROM THE BODY WITHOUT DIFFICULTY. THE BAKRI HAD A STRAIGHT TEAR OR SLICE LENGTHWISE DOWN THE BALLOON BUT OTHERWISE WAS INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556748 ↗
• MalfunctionOct 21, 2024Inflation Problem; Inflation Problem

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

  Patient problems: Insufficient Information

  MAUDE report 20495097 ↗
• MalfunctionOct 21, 2024Infusion or Flow Problem; Infusion or Flow Problem

  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 20495007 ↗
• MalfunctionOct 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IN ADDITIONAL INFORMATION RECEIVED 23OCT2024, IT WAS REPORTED THAT THE COMPLAINT DEVICE WAS INDWELLING FOR APPROXIMATELY 20 MINUTES. THE ESTIMATED BLOOD LOSS WAS VERY LITTLE; ABOUT 30 ML PRIOR TO THE BALLOON FALLING OUT, AND MINIMAL WHILE WAITING FOR ANOTHER ONE TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494925 ↗
• MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS' TUBE WAS LEAKING FLUIDS DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20493748 ↗
• InjuryOct 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  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 20477495 ↗
• MalfunctionSep 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  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 20334605 ↗
• MalfunctionSep 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 'COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS' LEAKED DURING TREATMENT OF POSTPARTUM HEMORRHAGE. FOLLOWING A VAGINAL DELIVERY, THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 640ML. THE USER PLACED THE DEVICE TRANSVAGINALLY AND INFLATED WITH 400ML OF SALINE. IT WAS THEN NOTED THAT THE BALLOON WAS LEAKING. THE DEVICE WAS REMOVED AND A SMALL HOLE WAS NOTED IN THE BALLOON. THE DEVICE WAS REPLACED WITH A NEW 'BAKRI' TO COMPLETE THE PROCEDURE AND HEMOSTASIS WAS ACHIEVED. THE PATIENT LOST AN ADDITIONAL ~300ML OF BLOOD FOLLOWING DEVICE USE; TOTAL ESTIMATED BLOOD LOSS WAS 1100ML. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. THE DEVICE WAS NOT HANDLED BY OR IN THE PROXIMITY OF ANY METAL TOOLS (I.E., FORCEPS OR SUTURE NEEDLES) THAT MAY HAVE DAMAGED THE BALLOON. NO SECTION OF THE DEVICE REMAINS INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20177182 ↗
• InjurySep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  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 20156918 ↗
• MalfunctionSep 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  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 20145880 ↗
• MalfunctionAug 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  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 20085914 ↗
• MalfunctionAug 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL CORRECTED INFORMATION RECEIVED 04SEP2024: PATIENT AGE AND DATE OF EVENT CORRECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077843 ↗
• MalfunctionJul 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS WAS USED TO TREAT POSTPARTUM HEMORRHAGE [PPH], DUE TO UTERINE ATONY, AFTER THE PATIENT HAD LOST APPROXIMATELY 600 ML OF BLOOD. PRIOR TO PLACEMENT OF THE BAKRI DEVICE, THE PATIENT WAS ADMINISTERED IV UTEROTONICS. THE DEVICE WAS PLACED BY HAND AND INFLATED TO 300ML. IT WAS DISCOVERED THAT THE BALLOON FELL OUT OF THE VAGINA WHEN THEY PERFORMED AN ULTRASOUND SCAN. THE DEVICE WAS PLACED AND INFLATED AGAIN AND THE DEVICE FELL OUT OF THE VAGINA FOR A SECOND TIME. THEY DISCONTINUED USE OF THE BAKRI POSTPARTUM BALLOON AND USED AN UNSPECIFIED, COMPETITORS, POSTPARTUM BALLOON TO CONTINUE TREATING THE PATIENT. WHEN THE BAKRI DEVICE WAS INSPECTED, THEY FOUND THAT THE DEVICE WAS LEAKING FROM THE TIP OF THE BALLOON. IT WAS REPORTED THAT THE DEVICE WAS NOT TESTED PRIOR TO USE AND THAT THE DEVICE WAS PLACED WITHIN TWELVE HOURS OF DELIVERY, BUT AN EXACT TIME FRAME COULD NOT BE PROVIDED. 100ML OF BLOOD WAS LOST AFTER DEVICE FAILURE, FOR A TOTAL ESTIMATED BLOOD LOSS OF 700ML. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19776621 ↗
• MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  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 19667018 ↗
• MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, A 'COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTALLATION COMPONENTS' BALLON LEAKED AND WAS UNABLE TO INFLATE DURING TREATMENT OF A POSTPARTUM HEMORRHAGE [PPH]. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME-LIKE DEVICE. IT WAS REPORTED, THERE WAS A DELAY IN TREATMENT OF THE POSTPARTUM HEMORRHAGE [PPH] DUE TO THE LEAKAGE. HOWEVER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666786 ↗
• MalfunctionJun 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THAT AFTER CHILDBIRTH, THE PATIENT LOST ABOUT 350 ML OF BLOOD DUE TO UTERINE ATONY. THE SURGEON PLACED THE BALLOON INTO THE PATIENT'S BODY THROUGH THE VAGINA TO STOP THE BLEEDING. WHEN THE BALLOON WAS FILLED WITH ABOUT 300 ML OF WATER, IT WAS FOUND THAT THE BALLOON WAS LEAKING. A NEW BALLOON WAS IMMEDIATELY PLACED TO STOP BLEEDING. AFTER THE LEAKAGE OCCURRED, THE PATIENT LOST ABOUT 500 ML OF BLOOD FOR A TOTAL BLOOD LOSS OF 850 ML. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19597915 ↗