Hemospray G56572Recalls & reported problems

Summary

The FDA's MAUDE database contains 452 adverse event reports that list this exact device (DI 00827002565722), received between Jul 5, 2018 and Sep 30, 2026 — classified as 1 death, 61 injuries, 390 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (285 reports).

3 FDA recall records name this device's identifier, 3 still open.

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.

Recalls naming this device

1. Aug 20, 2026Open, Classified

   Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

   Z-3177-2026 · Root cause: Labeling design · FDA record ↗

2. Aug 29, 2024Open, Classified

   Specific lots of product have been manufactured with nonconforming raw materials.

   Z-0036-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

3. May 22, 2023Open, Classified

   There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

   Z-1978-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 452 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Activation Failure

  During an unknown endoscopic procedure, the physician used a Cook Hemospray Endoscopic Hemostat.It was reported that they had a problem with the release of Hemospray powder. They managed to make a first release of dust "[spray]" but then had no more CO2 "[carbon dioxide]".At the time of this report, our attempts to collect additional information regarding patient outcome have been unsuccessful. While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted. Additional attempts to gather this information will be made.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948580 ↗
• MalfunctionSep 30, 2026Activation Failure

  During an unknown endoscopic procedure, the physician used a Cook Hemospray Endoscopic Hemostat. It was reported that they had a problem with the release of Hemospray powder. Once the red ring nut was screwed on, they heard the CO2 cylinder vent without the possibility of releasing dust.At the time of this report, our attempts to collect additional information regarding patient outcome have been unsuccessful. While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted. Additional attempts to gather this information will be made.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947588 ↗
• InjurySep 29, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941349 ↗
• InjurySep 29, 2026Obstruction of Flow; Activation Failure

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 50941288 ↗
• MalfunctionSep 29, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936728 ↗
• MalfunctionSep 29, 2026Failure to Disconnect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936676 ↗
• MalfunctionSep 21, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843097 ↗
• MalfunctionSep 21, 2026Activation Failure

  During an endoscopic hemostasis procedure in the stomach, the physician used a Cook Hemospray Endoscopic Hemostat.It was reported that the powder was not coming out. The tool "[catheter]" was already in the patient "[unable to spray - subject of report]".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 50841968 ↗
• MalfunctionSep 16, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793091 ↗
• MalfunctionSep 15, 2026Complete Blockage; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779987 ↗
• MalfunctionSep 15, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779557 ↗
• MalfunctionSep 11, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736869 ↗
• MalfunctionSep 8, 2026Activation Failure

  During an endoscopic hemostasis procedure, the physician used three (3) Cook Hemospray Endoscopic Hemostats. It was reported that the three (3) devices all had the same issue of not dispensing the powder as if it was clogged. They changed catheters and had the same issue.At the time of this report, our attempts to collect additional information regarding patient outcome have been unsuccessful. While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672544 ↗
• MalfunctionSep 8, 2026Activation Failure

  During an endoscopic hemostasis procedure, the physician used a Cook Hemospray Endoscopic Hemostat. It was reported that "[the device]" did not deploy "[Unable to spray powder]".At the time of this report, our attempts to collect additional information regarding patient outcome have been unsuccessful. While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670219 ↗
• MalfunctionAug 19, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50313375 ↗
• InjuryAug 12, 2026Activation Failure

  During an endoscopic gastrointestinal hemostasis procedure, the physician used a Cook Hemospray Endoscopic Hemostat. It was reported that the trigger button was pressed to deliver powder to the target site during endoscopic gastrointestinal hemostasis; however, no powder was emitted. The procedure was completed using an alternative product.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: Gastrointestinal Hemorrhage

  MAUDE report 50225648 ↗
• MalfunctionAug 7, 2026Obstruction of Flow; Activation Failure

  During an endoscopic hemostasis procedure, the physician used a Cook Hemospray Endoscopic Hemostat. It was reported that during use, the device failed to dispense spray. A second device of the same model was opened and functioned as intended.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 50179725 ↗
• MalfunctionJun 8, 2026Activation Failure

  DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE IN THE GASTRIC ANTRUM, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE PUMP ON DEVICE WAS DEFECTIVE. USED ANOTHER OF THE SAME DEVICE AND IT WORKED PERFECTLY. ADDITIONAL INFORMATION PER COOK DISTRICT MANAGER RECEIVED ON (B)(6) 2026: THEY SETUP THE HEMOSPRAY PER THE STEPS IN THE IFU, ACTIVATED CO2 [CARBON DIOXIDE] CARTRIDGE BY TURNING THE RED ACTIVATION KNOB UNTIL IT STOPPED, ATTACHED CATHETER TO THE HANDLE, TURNED THE RED ON/OFF VALVE TO THE OPEN POSITION PARALLEL WITH THE DIRECTION OF THE SPRAY, AND THEN PRESSED THE RED TRIGGER BUTTON FOR TWO (2) SECONDS BUT NO POWDER WAS DEPLOYED. THEY PRESSED THE RED TRIGGER BUTTON FOR TWO (2) SECONDS AGAIN, AND STILL NO POWDER WAS DEPLOYED. THEY CONFIRMED THAT THE RED ON/OFF VALVE WAS IN THE OPEN POSITION, PRESSED THE RED TRIGGER BUTTON FOR TWO (2) SECONDS, AND STILL NO POWDER WAS DEPLOYED. THEY REMOVED THE CATHETER FROM THE ENDOSCOPE, POINTED THE CATHETER IN A SAFE DIRECTION AND PRESSED THE RED TRIGGER BUTTON FOR TWO (2) SECONDS AND NO POWDER WAS DEPLOYED AND NO CO2 WAS FELT EXITING THE CATHETER. AT THIS POINT, THEY OPENED A NEW HEMOSPRAY, SETUP THE DEVICE PER THE STEPS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430834 ↗
• InjuryJun 5, 2026Complete Blockage; Activation Failure

  DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE IN THE DUODENUM, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE POWDER SPRAYING WAS INITIALLY SUCCESSFUL BUT BECAME IMPOSSIBLE DURING THE PROCEDURE. THE CATHETER WAS REPLACED DUE TO SUSPECTED CLOGGING; HOWEVER, SPRAYING STILL FAILED, AND HEMOSTASIS COULD NOT BE ACHIEVED. THE PROCEDURE WAS COMPLETED USING CLIPS AND HEMOSTATIC FORCEPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. HEMOSTASIS WAS ACHIEVED USING AN ALTERNATE MODALITY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 25411056 ↗
• MalfunctionJun 1, 2026Material Twisted/Bent; Activation Failure

  DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE FOR A BLEED IN THE DIVERTICULUM, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT WHILE APPLYING THE POWDER, THE POWDER WOULD NOT COME OUT. A KINK WAS NOTED IN THE CATHETER, AND THE MEDICAL STAFF UNKINKED IT. THEN AT THE LUER LOCK THERE WAS A BIG POOF OF POWDER, AND THE DEVICE RAN OUT OF CO2 [UNABLE TO SPRAY - SUBJECT OF REPORT]. THE SECOND CATHETER WAS NOT USED; THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 25354681 ↗
• MalfunctionMay 20, 2026Activation Failure

  DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE FOR A GI BLEED, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE TECH WENT TO ACTIVATE THE HEMOSPRAY AND IT DID NOT PROPEL THE POWDER [UNABLE TO SPRAY - SUBJECT OF REPORT]. THEN THEY WENT TO USE A SECOND HEMOSPRAY AND THAT ONE FAILED IN THE EXACT SAME WAY. THE PROCEDURE WAS FINISHED WITHOUT THE USE OF THE HEMOSPRAY. 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 25233722 ↗
• MalfunctionMay 19, 2026Activation Failure

  DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE FOR A GI BLEED, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT A HEMOSPRAY WAS OPENED TO USE WITH THE PHYSICIAN BUT WOULD NOT WORK [UNABLE TO SPRAY - SUBJECT OF REPORT]. THEY DOUBLE CHECKED TO MAKE SURE CONNECTIONS WERE CORRECT AND THEY WERE. A SECOND HEMOSPRAY WAS OPENED TO FINISH THE PROCEDURE 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 25216408 ↗
• MalfunctionMay 18, 2026Activation Failure

  DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT A RIGHT HEMICOLECTOMY WAS PERFORMED FOR TRANSVERSE COLON CANCER FOR A PATIENT ON (B)(6) 2026. ON (B)(6) 2026 POSTOPERATIVE BLEEDING WAS OBSERVED AT THE ANASTOMOTIC SITE. WHEN ATTEMPTING TO APPLY HEMOSPRAY, POWDER COULD NOT BE SPRAYED FROM THE JUNCTION BETWEEN THE HANDLE AND THE CATHETER. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME SPECIFICATION, AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED 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 25201996 ↗
• MalfunctionMay 14, 2026Obstruction of Flow; Activation Failure

  DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO OPERATE [UNABLE TO SPRAY - SUBJECT OF REPORT] DESPITE FOLLOWING THE INSTRUCTIONS FOR USE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 25176700 ↗
• MalfunctionMay 14, 2026Obstruction of Flow; Activation Failure

  DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO OPERATE [UNABLE TO SPRAY - SUBJECT OF REPORT] DESPITE FOLLOWING THE INSTRUCTIONS FOR USE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 25176004 ↗