BakriRecalls & reported problems across all models

We found 2 models of Bakri by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 584 adverse event reports in the FDA's MAUDE database, received between May 12, 2016 and Jan 7, 2026 — classified as 89 injuries, 495 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (314 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bakri problems

Bakri models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bakri G30673

  Intrauterine tamponade balloon
  355 reports
• Bakri G24237

  Intrauterine tamponade balloon
  229 reports

Recent Bakri adverse event reports

The 15 most recent reports across all models, 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 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) SECONDARY TO UTERINE ATONY, A PINHOLE LEAK WAS FOUND IN 'BAKRI TAMPONADE BALLOON CATHETER'. THE PATIENT LOST 460 ML OF BLOOD DURING A CESAREAN SECTION. THE PHYSICIAN PLACED THE BALLOON TO FILL IT WITH WATER, AND THE BLOOD WAS STILL FLOWING FROM THE VAGINAL OPENING. THE PHYSICIAN IMMEDIATELY DEFLATED THE BALLOON AND REMOVED IT TO FIND THAT THE BALLOON HAD "THREE NEEDLE-TIP-LIKE LEAKS". THE PHYSICIAN REPORTED THAT AN EDENTULOUS OVAL FORCEPS WAS USED FOR PLACEMENT AND THAT THE NEEDLE TIP WAS NOT "TOUCHED" DURING THE OPERATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER BALLOON. REPORTEDLY, THE PATIENT LOST A TOTAL OF 560 ML BLOOD AND DID NOT REQUIRE A BLOOD TRANSFUSION. A SECTION OF THE BALLOON DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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 22859987 ↗
• MalfunctionAug 20, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  AS REPORTED, DURING TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) SECONDARY TO UTERINE ATONY, THE CATHETER AND VALVE SPIRAL INTERFACE OF 'BAKRI TAMPONADE BALLOON CATHETER' WAS LOOSE. AS REPORTED, THE MATERNAL BLEEDING AFTER CESAREAN SECTION EXCEEDED 700 ML. THE PHYSICIAN USED THE BALLOON TO STOP THE BLEEDING OF THE PATIENT. REPORTEDLY, THE CATHETER AND VALVE SPIRAL INTERFACE WAS VERY LOOSE AND CAME OFF EASILY WHEN THE BALLOON WAS INJECTED WITH LIQUID. THE BALLOON WAS NOT REPLACED AND THE PROCEDURE WAS COMPLETED "CAREFULLY". POSTOPERATIVELY, THE CONDITION OF THE PATIENT WAS MONITORED CLOSELY. SUBSEQUENTLY, THE BALLOON WAS REMOVED AT NOON NEXT DAY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854011 ↗
• 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 ↗
• MalfunctionAug 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING TREATMENT OF POSTPARTUM HEMORRHAGE, SECONDARY TO UTERINE ATONY, THE 'BAKRI TAMPONADE BALLOON CATHETER' LEAKED. THE ISSUE WAS IDENTIFIED WHEN SALINE WAS INJECTED TO CHECK THE INTEGRITY OF THE WELL PACKED BALLOON CATHETER BEFORE TRANSVAGINAL PLACEMENT. REPORTEDLY, BLOOD LOSS PRIOR TO FAILURE IS UNKNOWN SINCE THE BALLOON WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING WITH AN UNSPECIFIED NEW BALLOON. REPORTEDLY, THE POSTOPERATIVE TOTAL BLEEDING WAS 400 ML WITH NO TRANSFUSION PERFORMED, AND THE FINAL HEMOSTASIS WAS SUCCESSFUL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE OR EXPERIENCE ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833967 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, A BAKRI TAMPONADE BALLOON CATHETER WAS USED FOR TREATMENT OF POSTPARTUM HEMORRHAGE (PPH). THE BALLOON WAS PLACED INTO THE PATIENT AND INFLATED WITH 300 ML OF SALINE SOLUTION; AN ULTRASOUND WAS VIEWED ONE HOUR AFTER THE PROCEDURE TO SHOW THAT THE BALLOON WAS LOCATED IN THE LOWER PART OF THE UTERINE CAVITY AND THE WATER SAC WAS FILLED. AT TWENTY-FOUR HOURS AFTER THE PROCEDURE, THE BALLOON WAS READY TO BE REMOVED FROM THE UTERINE CAVITY. THE SYRINGE FAILED TO WITHDRAW THE FLUID FROM THE BALLOON REPEATEDLY, AND THE DOCTOR PULLED THE DRAINAGE TUBE AT THE END OF THE BALLOON, WHICH CAME OUT OF THE UTERINE CAVITY ON ITS OWN. THERE WAS NO SALINE SOLUTION LEFT IN THE BALLOON. THE USER THEN INJECTED 300 ML OF SALINE INTO THE BALLOON, AND IT WAS IN PLACE FOR FOUR HOURS MORE WITHOUT LEAKAGE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730349 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, FOLLOWING A CESAREAN DELIVERY, A 'BAKRI TAMPONADE BALLOON CATHETER' LEAKED DURING TREATMENT OF POSTPARTUM HEMORRHAGE (PPH). PRIOR TO PLACEMENT THE BALLOON AFTER CESAREAN, UTERINE CONTRACTIONS WERE POOR DUE TO ATONY OF THE LOWER UTERINE SEGMENT, AND THE PATIENT LOST 600 ML OF BLOOD. DURING TRANSVAGINAL EXPLORATION, THE BALLOON WAS PLACED INTO THE UTERINE CAVITY FOR SALINE INJECTION AND LEAKAGE WAS FOUND. THE PATIENT LOST 200 ML OF BLOOD AFTER THE DEVICE FAILURE. TOTAL BLEEDING REPORTED WAS 800 ML. HEMOSTASIS WAS ACHIEVED THROUGH PLACEMENT OF A SECOND BAKRI DEVICE INJECTED WITH FLUID AND COMPRESSION. IT WAS REPORTED THAT THE BALLOON WAS NOT HANDLED IN PROXIMITY OF ANY METAL TOOLS. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556602 ↗
• MalfunctionJul 21, 2025Fluid/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 22555246 ↗
• MalfunctionJul 10, 2025Material Rupture; Material Rupture

  AS REPORTED, FOLLOWING A CESAREAN DELIVERY, THE BAKRI TAMPONADE BALLOON CATHETER'S BALLOON RUPTURED DURING TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) SECONDARY TO UTERINE ATONY. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 600ML. THE BALLOON WAS THEN PLACED INTO THE PATIENT, BUT IT DID NOT INFLATE AFTER SEVERAL WATER INJECTIONS. UPON INSPECTION, THE BALLOON WAS FOUND TO BE RUPTURED. IT WAS IMMEDIATELY REPLACED WITH A NEW ONE. THE TOTAL ESTIMATED BLOOD LOSS WAS 680ML. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470188 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413148 ↗
• InjuryJun 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AFTER A VAGINAL DELIVERY; THE PATIENT LOST ABOUT 600ML OF BLOOD. A BAKRI TAMPONADE BALLOON CATHETER WAS PLACED TRANSVAGINALLY AS TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) THE DEVICE WAS NOT HANDLED BY OR IN THE PROXIMITY OF ANY METAL TOOLS THAT MAY HAVE DAMAGED THE BALLOON. THE USER FOUND THAT THERE WAS A LEAK WHEN INJECTING WATER IN THE BALLOON AND IT COULD NOT BE USED NORMALLY. THE BALLOON WAS REMOVED IMMEDIATELY. THE PATIENT CONTINUED TO LOSE APPROXIMATELY 900ML OF BLOOD. TOTAL ESTIMATED BLOOD LOSS OF 1500ML. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. THE PATIENT RECEIVED 2 UNITS OF RED BLOOD CELL SUSPENSION, TRANSFUSED WITHIN 30 MINUTES, FOLLOWED BY 600ML OF FRESH FROZEN PLASMA. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22346892 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, FOLLOWING A CESAREAN DELIVERY, A 'BAKRI TAMPONADE BALLOON CATHETER' WAS TO BE USED FOR TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) SECONDARY TO UTERINE ATONY. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 400 ML. BEFORE PLACING THE BALLOON, THE INNER AND OUTER PACKAGING WAS INSPECTED PRIOR TO USE AND FOUND TO BE INTACT. PRIOR TO USE, BALLOON INTEGRITY WAS TESTED BY INJECTING SALINE SOLUTION WITH LEAKING NOTED FROM THE BALLOON. THE USER REPLACED THE DEVICE WITH A SIMILAR ONE TO COMPLETE THE PROCEDURE AND HEMOSTASIS WAS ACHIEVED. THE TOTAL ESTIMATED BLOOD LOSS WAS 500 ML. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION 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 22335517 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  AS REPORTED, FOLLOWING A CESAREAN DELIVERY OF TWINS, A 'BAKRI TAMPONADE BALLOON CATHETER' WAS USED FOR TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) WITH SIGNIFICANT VAGINAL BLEEDING, SECONDARY TO UTERINE ATONY. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 500 ML. THE BALLOON WAS PLACED INTO THE PATIENT AND INFLATED WITH 500ML SALINE SOLUTION WHEN LEAKING WAS NOTED THROUGH THE VAGINA. UPON REMOVAL, THE BALLOON WAS FOUND TO BE LEAKING. THE USER REPLACED THE DEVICE TO COMPLETE THE PROCEDURE AND HEMOSTASIS WAS ACHIEVED. THE PATIENT LOST 100ML OF BLOOD AFTER THE DEVICE FAILURE. THE TOTAL ESTIMATED BLOOD LOSS WAS 600 ML. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298918 ↗
• MalfunctionJun 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, FOLLOWING A CESAREAN DELIVERY, A 'BAKRI TAMPONADE BALLOON CATHETER' WAS USED FOR TREATMENT OF POSTPARTUM HEMORRHAGE (PPH). THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 1300 ML. THE BALLOON WAS THEN PLACED INTO THE PATIENT AND INFLATED WITH 180 ML OF SALINE SOLUTION. THE DEVICE WAS FOUND TO BE "ABNORMAL", AND IT WAS REMOVED STILL CONTAINING THE SALINE SOLUTION. LEAKING WAS NOTED AT THE ANTERIOR END OF THE BALLOON CATHETER AND BALLOON JUNCTION. THE BALLOON HAD NOT COME INTO CONTACT WITH ANY METAL TOOLS. ESTIMATED BLOOD LOSS AFTER DEVICE FAILURE WAS 100-150 ML. THE USER REPLACED THE DEVICE TO COMPLETE THE PROCEDURE AND HEMOSTASIS WAS ACHIEVED. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213624 ↗
• MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, FOLLOWING A VAGINAL DELIVERY, A 'BAKRI TAMPONADE BALLOON CATHETER' WAS USED FOR TREATMENT OF POSTPARTUM HEMORRHAGE (PPH) SECONDARY TO UTERINE ATONY. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 500ML PRIOR TO BALLOON PLACEMENT. THE DOCTOR PLACED THE BALLOON INTO THE PATIENT USING A METAL TOOL. THE BALLOON WAS INFLATED WITH WATER AND LEAKING WAS NOTED. THE PATIENT CONTINUED TO LOSE AN ADDITIONAL 100ML OF BLOOD. THE USER REPLACED THE DEVICE TO COMPLETE THE PROCEDURE AND HEMOSTASIS WAS ACHIEVED. TOTAL BLOOD LOSS WAS 600ML. THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193297 ↗

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