FREEDOM60® F10050Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00659443000001), received between Jun 28, 2019 and Jul 30, 2026 — classified as 58 malfunctions.

The most frequently reported specific device problem is “Unintended Ejection” (54 reports).

1 other recall cover devices cleared under the same FDA submission (K162613, K933652); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Unintended Ejection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083506 ↗
• MalfunctionFeb 20, 2026Unintended Ejection

  KORU MEDICAL BECAME AWARE OF THE FOLLOWING REPORT DURING A LITERATURE SEARCH REVIEW STATING "ONE TIME THE SYRINGE FLEW OUT OF THE DEVICE AND HIT ME IN THE FACE. AND THAT WAS BECAUSE I DID NOT WIND THE TAB [ON THE FREEDOM60 PUMP] BACK BEFORE I PUT THE SYRINGE INTO THE DEVICE. AND SO WHEN I TURNED IT ON, IT [THE SYRINGE] FLEW OUT AND HIT ME IN THE FACE." NO FURTHER INFORMATION IS KNOWN OR REPORTED. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402466 ↗
• MalfunctionJan 14, 2026Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5179556 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. PT REPORTS THEIR FREEDOM PUMP WAS NOT WORKING RIGHT & THE SYRINGE WAS POPPING OUT, WHICH HAS BEEN HAPPENING FOR THE PAST 2-3 INFUSIONS. RPH REVIEWED HOW TO SET UP INFUSION WITH ADAPTER & HIZENTRA 20% 10GM PREFILLED SYRINGE DIRECTLY IN PUMP; PT WAS ABLE TO GET PUMP WORKING. RPH DID REVIEW HOW TO DO MANUAL INFUSION IF NEEDED. THE PHARMACY WILL REPLACE THE FREEDOM PUMP, WHICH IS AVAILABLE FOR RETURN. IT IS UNKNOWN IF THE PT EXPERIENCED AN ADVERSE EVENT DUE TO PUMP ISSUE. PUMP SERIAL NUMBER IS UNKNOWN. PT ALSO VOICED CONCERN THAT THEY ARE NOT GETTING THE FULL DOSE AS THERE IS A GREY PORTION AT THE TOP OF THE HIZENTRA 20% 10GM PREFILLED SYRINGE THAT THEY HAVE NOT SEEN BEFORE. RPH ADVISED THERE IS NO LESS MED IN THE SYRINGE BUT PT WANTS CONFIRMATION FROM MANUFACTURER. RPH OFFERED NURSING REFRESH FOR TEACH/TRAIN BUT PT DECLINED. PT ALSO STATES THEY WOULD NOT BE ABLE TO VISIT THE HIZENTRA WEBSITE FOR TRAINING VIDEOS. PER PT REQUEST, PHARMACY RPH CALLED CSL BEHRING (800-504-5434) & SPOKE WITH RPH/MEDICAL INFO SPECIALIST (B)(4) REGARDING PT QUES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069324 ↗
• MalfunctionJan 14, 2026Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5179556 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. PT REPORTS THEIR FREEDOM PUMP WAS NOT WORKING RIGHT & THE SYRINGE WAS POPPING OUT, WHICH HAS BEEN HAPPENING FOR THE PAST 2-3 INFUSIONS. RPH REVIEWED HOW TO SET UP INFUSION WITH ADAPTER & HIZENTRA 20% 10GM PREFILLED SYRINGE DIRECTLY IN PUMP; PT WAS ABLE TO GET PUMP WORKING. RPH DID REVIEW HOW TO DO MANUAL INFUSION IF NEEDED. THE PHARMACY WILL REPLACE THE FREEDOM PUMP, WHICH IS AVAILABLE FOR RETURN. IT IS UNKNOWN IF THE PT EXPERIENCED AN ADVERSE EVENT DUE TO PUMP ISSUE. PUMP SERIAL NUMBER IS UNKNOWN. PT ALSO VOICED CONCERN THAT THEY ARE NOT GETTING THE FULL DOSE AS THERE IS A GREY PORTION AT THE TOP OF THE HIZENTRA 20% 10GM PREFILLED SYRINGE THAT THEY HAVE NOT SEEN BEFORE. RPH ADVISED THERE IS NO LESS MED IN THE SYRINGE BUT PT WANTS CONFIRMATION FROM MANUFACTURER. RPH OFFERED NURSING REFRESH FOR TEACH/TRAIN BUT PT DECLINED. PT ALSO STATES THEY WOULD NOT BE ABLE TO VISIT THE HIZENTRA WEBSITE FOR TRAINING VIDEOS. PER PT REQUEST, PHARMACY RPH CALLED CSL BEHRING (B)(6) & SPOKE WITH RPH/MEDICAL INFO SPECIALIST (B)(4) REGARDING PT QUESTIONS AB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069322 ↗
• MalfunctionJan 14, 2026Unintended Ejection

  (B)(6) BECAME AWARE OF MW5179556 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. PT REPORTS THEIR FREEDOM PUMP WAS NOT WORKING RIGHT & THE SYRINGE WAS POPPING OUT, WHICH HAS BEEN HAPPENING FOR THE PAST 2-3 INFUSIONS. RPH REVIEWED HOW TO SET UP INFUSION WITH ADAPTER & HIZENTRA 20% 10GM PREFILLED SYRINGE DIRECTLY IN PUMP; PT WAS ABLE TO GET PUMP WORKING. RPH DID REVIEW HOW TO DO MANUAL INFUSION IF NEEDED. THE PHARMACY WILL REPLACE THE FREEDOM PUMP, WHICH IS AVAILABLE FOR RETURN. IT IS UNKNOWN IF THE PT EXPERIENCED AN ADVERSE EVENT DUE TO PUMP ISSUE. PUMP SERIAL NUMBER IS UNKNOWN. PT ALSO VOICED CONCERN THAT THEY ARE NOT GETTING THE FULL DOSE AS THERE IS A GREY PORTION AT THE TOP OF THE HIZENTRA 20% 10GM PREFILLED SYRINGE THAT THEY HAVE NOT SEEN BEFORE. RPH ADVISED THERE IS NO LESS MED IN THE SYRINGE BUT PT WANTS CONFIRMATION FROM MANUFACTURER. RPH OFFERED NURSING REFRESH FOR TEACH/TRAIN BUT PT DECLINED. PT ALSO STATES THEY WOULD NOT BE ABLE TO VISIT THE HIZENTRA WEBSITE FOR TRAINING VIDEOS. PER PT REQUEST, PHARMACY RPH CALLED CSL BEHRING (800-504-5434) & SPOKE WITH RPH/MEDICAL INFO SPECIALIST (B)(4) REGARDING PT QUESTIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069321 ↗
• MalfunctionDec 1, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5177487 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PATIENT REPORT THEIR FREEDOM PUMP, USED FOR HIZENTRA INFUSIONS, SERIAL NUMBER (B)(6), IS OLD AND NOT WORKING PROPERLY. PT REPORTS SYRINGE SHOOTING OUT OF PUMP WITH LAST INFUSION AND HAD TO HOLD SYRINGE DOWN. PATIENT REPORTS THEY DID NOT MISS A DOSE, NOR HAD AN INTERRUPTION IN THERAPY. IT IS UNKNOWN IF PATIENT EXPERIENCED AN ADVERSE EVENT DUE TO PRODUCT ISSUE. PHARMACY REPLACED THE DEVICE AND THE MALFUNCTIONING DEVICE WILL NOT BE RETURNED. UNKNOWN IF MD IS AWARE. NO FURTHER INFORMATION, DETAILS, OR DATES PROVIDED. INDICATIONS: IMMUNODEFICIENCY WITH PREDOMINANTLY ANTIBODY DEFECTS, UNSPECIFIED, SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN G [IGG] SUBCLASSES, AND COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED." NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT. FOLLOW UP WITH THE INITIAL REPORTER IS BEING CONDUCTED FOR ADDITIONAL DETAILS. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681076 ↗
• MalfunctionDec 1, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL RECEIVED ADDITIONAL INFORMATION ON 05-DEC-2025 PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681075 ↗
• MalfunctionNov 14, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5176432 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PT STATED THAT SHE WAS GOING TO DO HER SECOND INFUSION FOR THE WEEK EARLIER THIS MORNING AROUND 8AM AND WAS HAVING TROUBLE WITH THE PUMP. SHE SAID SHE HAD EVERYTHING SET UP BUT INFUSION WOULDN'T START. SHE TOOK THE SYRINGE OUT, PLACED IT BACK IN AND TRIED TO REWIND THE PUMP BUT IT WASN'T MAKING THE WINDUP NOISE SHE NORMALLY HEARS AND THE SYRINGE SPIT OUT. SHE PUT THE SYRINGE IN THE FRIDGE AND WENT TO WORK. INITIALLY RECOMMENDED TO TRY TO DO MANUAL PUSH OF MED SINCE NO VOLUME WAS LOST AND STILL WITHIN 8HR TIME FRAME BUT PATIENT PLACED SYRINGE IN FRIDGE AND WE HAVE NO STABILITY DATA ON CUTAQUIG ONCE PLACED IN FRIDGE AFTER BEING AT ROOM TEMP. ADVISED I WILL REACH OUT TO MD TO SEE IF THEY WANT TO PROVIDE MAKEUP DOSE OR IF SHE SHOULD SKIP THIS SECOND DOSE AND RESUME NORMAL SCHEDULE NEXT WEEK (SUNDAY). NO FURTHER QUESTIONS FOR RPH. NO FURTHER INFORMATION PROVIDED. SERIAL NUMBER (B)(6). 1. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES. 2. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. 3. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? NOT REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555020 ↗
• MalfunctionAug 4, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5172128 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. PT REQUEST A REPLACEMENT PUMP, PT SAID SHE HAD THE INFUSION SET UP LIKE SHE ALWAYS DOES AND WHEN SHE TURNED ON THE PUMP THE SYRINGE FLEW OUT OF THE PUMP, AND IT KEEPS SPINNING. CONFIRMED SHE HAD THE INFUSION SET UP CORRECTLY WITH THE FLOW RATE TUBING DISC SIDE CONNECTING TO THE SYRINGE AND STILL NOT WORKING. PT THINKS SOMETHING IS WRONG WITH THE PUMP. ADVISE WE WILL SEND A NEW PUMP. ADVISED PT SHE CAN MANUALLY PUSH THE MEDICATION SINCE SHE ALREADY ATTACHED NEEDLE SET AND FLOW RATE TUBING TO THE HIZENTRA PFS. ADVISED PT CAN MANUALLY PUSH. PT TRIED THAT AND WAS GETTING RESISTANCE. SERIAL NUMBER: (B)(6). EXPIRATION DATE 04/16/2025. UNKNOWN IF THE PATIENT MISSED A DOSE OR EXPERIENCED AN ADVERSE EVENT AS A RESULT OF THE DEFECTIVE PRODUCT. UNKNOWN IF THE PT HAS THE DEFECTIVE PRODUCT ON HAND FOR POSSIBLE RETURN TO THE MANUFACTURER. NO FURTHER INFORMATION IS KNOWN." ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708205 ↗
• MalfunctionJul 1, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT FROM AN END-USER STATING "I ALREADY REPORTED THIS TO THE PHARMACY THAT SENT OUT THE ADAPTER FOR THE PREFILLED SYRINGES. I THINK MINE'S DEFECTIVE AND I'M WONDERING IF OTHER PEOPLES ARE DEFECTIVE AS THE PHARMACY HAS NOT GOTTEN A REPORT OF THAT, BUT I SENT THEM A VIDEO OF THE PUMP AND THE ADAPTER AND THE SYRINGE SHOOTING OUT THE FRONT." NO ADVERSE EVENTS OCCURRED. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371475 ↗
• MalfunctionMar 21, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5166617 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. PT STATES FIRST INFUSION WORKED FINE, BUT SECOND TIME SYRINGE WOULD NOT STAY IN PLACE AND CONTINUED TO POP OUT. PT TRIED MULTIPLE DIFFERENT SYRINGES AND DID NOT WORK. (UNKNOWN WHAT PT MEANT BY FIRST INFUSION AND SECOND TIME). PHARMACIST DETERMINED THAT PUMP (SERIAL NUMBER AND EXPIRATION DATE NOT SPECIFIED) IS MALFUNCTIONING. UNKNOWN IF MD IS AWARE. UNKNOWN IF MISSED DOSE OR HAD AN INTERRUPTION TO THERAPY. UNKNOWN IF PRODUCT IS AVAILABLE FOR RETURN. PHARMACY TO REPLACE DEVICE. UNKNOWN DATE OF MALFUNCTION. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER." A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 07-MARCH-2025 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED PROVIDING PATIENT INFORMATION AND STATED THE REPORTER DID NOT PROVIDE THE SERIAL NUMBER OF THE PUMP INVOLVED, THEREFORE IT IS UNKNOWN. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21670958 ↗
• MalfunctionFeb 21, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5164473 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. PT ADVISED PUMP (SERIAL NUMBER AND EXPIRATION DATE NOT PROVIDED.) STOP WORKING AND IS DAMAGED, CRACK ON FREEDOM PUMP. PT SAID WHILE TRYING TO LOAD THE SYRINGE TO FREEDOM PUMP LAST NIGHT, THE SYRINGE POPPED OUT OF THE PUMP TWICE AND THEN HE NOTICED A SMALL HAIR LINE CRACK ON THE FREEDOM PUMP. PT WAS ABLE TO FINISH INFUSION MANUALLY. CONFIRMED WITH PT HE HAD CONNECTED BOTH THE NEEDLE SET AND TUBING CORRECTLY LIKE HE ALWAYS DID WITH THE DISC SIDE GOING INTO THE PUMP. NO ADVERSE EVENT(S) REPORTED DUE TO PRODUCT ISSUE. PT SENT A BOX FOR RETURN OF DEVICE ASSOCIATED WITH EVENT. DEVICE WILL BE AVAILABLE ONCE RETURNED BY PT. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER." A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 28-JAN-2025 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED PROVIDING PATIENT INFORMATION AND STATED THE REPORTER DID NOT PROVIDE THE SERIAL NUMBER OF THE PUMP INVOLVED, THEREFORE IT IS UNKNOWN. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433215 ↗
• MalfunctionFeb 11, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5164197 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "SPONTANEOUS COMMUNICATION. PT REPORTED WHILE STARTING INFUSION LAST NIGHT AND WHEN TRYING TO LOAD SYRINGE INTO PUMP, IT KEPT SPRINGING BACK OUT. PUMP MADE CLICKING NOISES. PT WAS ABLE TO INFUSE MANUALLY. PHARMACY IS REPLACING PUMP. NO ADVERSE EVENTS OR MISSED DOSES REPORTED. UNKNOWN IF PUMP IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION AVAILABLE. PUMP SERIAL NUMBER WAS NOT REPORTED. INDICATION: COMMON VARIABLE IMMUNODEFICIENCY WITH PREDOMINANT ABNORMALITIES OF B-CELL NUMBERS AND FUNCTION. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER." NO ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT. A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 24-JAN-2025 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED PROVIDING PATIENT INFORMATION AND STATED THE REPORTER DID NOT PROVIDE THE SERIAL NUMBER OF THE PUMP INVOLVED, THEREFORE IT IS UNKNOWN. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356896 ↗
• MalfunctionFeb 11, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5164195 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PATIENT REPORTED THAT THEIR FREEDOM60 PUMP IS NOT WINDING AND THE BLACK PLUNGER IS STUCK AT TOP. PATIENT REPORTED THE PUMP SHOT SYRINGE OUT. UNKNOWN IF PATIENT HAS MISSED DOSE. UNKNOWN IF PATIENT EXPERIENCED AN ADVERSE EVENT AS A RESULT. UNKNOWN IF PATIENT HAS DEFECTIVE DEVICE ON HAND. ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM. PHARMACY IS REPLACING PUMP. PUMP SERIAL NUMBER WAS NOT REPORTED. INDICATIONS: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED; SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN G [IGG] SUBCLASSES; COMMON VARIABLE IMMUNODEFICIENCY WITH PREDOMINANT ABNORMALITIES OF B-CELL NUMBERS AND FUNCTION. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER." NO ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT. A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 24-JAN-2025 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED PROVIDING PATIENT INFORMATION AND STATED THE REPORTER DID NOT PROVIDE THE SERIAL NUMBER OF THE PUMP INVOLVED, THEREFORE IT IS UNKNOWN. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356088 ↗
• MalfunctionFeb 11, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT STATING ""DURING INFUSION, SYRINGE PLACED IN KORU PUMP. SYRINGE POPPED OUT WHEN TURNED ON. SYRINGE DRIVER NOSE NOTED WITH A CRACK." NO ADVERSE EVENTS OCCURRED. THE PUMP WILL NOT BE RETURNED TO KORU FOR EVALUATION. THE PATIENT WAS PROVIDED WITH A REPLACEMENT PUMP. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354958 ↗
• MalfunctionJan 24, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5163424 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PATIENT STATED THE ADAPTERS DON'T WORK AND THE HIZENTRA PFS SHOT OUT OF THE PUMP. NO FURTHER INFORMATION PROVIDED, UNKNOWN IF DEVICE ON HAND FOR POSSIBLE RETURN." NO ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT. A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 02-JAN-2025 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229806 ↗
• MalfunctionSep 26, 2024Unintended Ejection; Unintended Ejection

  AN END-USER NOTIFIED KORU MEDICAL ON 31-AUG-2024 OF A SYRINGE EJECTION EVENT WHICH OCCURRED ON 30-AUG-2024. THE END-USER STATED THE SYRINGE EJECTED FROM THE PUMP DURING SETUP. NO ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THE EVENT. NO FURTHER DETAILS PROVIDED AT THE TIME OF THE REPORT. THE KORU MEDICAL SCIENCE LIAISON IS CURRENTLY FOLLOWING UP WITH THIS USER FOR ADDITIONAL INFORMATION SURROUNDING THE EVENT AND PUMP DETAILS. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311304 ↗
• MalfunctionAug 26, 2024Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT STATING "PATIENT STATED WHEN SHE TRIED TO LOAD THE SYRINGE INTO THE PUMP. THE SYRINGE FELT LOOSE AND DID NOT ATTACH. WHEN THE PATIENT TURNED THE PUMP ON, THE GRABBER CAME DOWN AND FLUNG OUT OF THE SYRINGE. PATIENT TRIED TO HOLD DOWN THE SYRINGE BUT IT KEEPS FLINGING OUT." NO ADVERSE EVENTS OCCURRED AS A RESULT OF THE EVENT. A RETURN MATERIAL AUTHORIZATION WAS OPENED FOR RETURN OF THE PUMP TO KORU MEDICAL FOR EVALUATION. THE PUMP LISTED IN THIS REPORT WAS RECEIVED BY KORU ON 14-AUG-2024 AND IS PENDING EVALUATION. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071332 ↗
• MalfunctionMar 21, 2024Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT STATING "DURING SETUP, SYRINGE LOADED INTO PUMP AND WHEN SWITCH TURNED TO ON, THE SYRINGE SHOT OUT OF PUMP. ATTEMPTED AGAIN, AND SAME THING HAPPENED. NO ONE INJURED. ANOTHER PUMP USED TO INFUSE PATIENT'S MED WITHOUT INCIDENT." A RETURN MATERIAL AUTHORIZATION WAS OPENED FOR RETURN OF THE PUMP TO KORU MEDICAL FOR EVALUATION. THE KORU MEDICAL SCIENCE LIAISON CONTACTED THE INITIAL REPORTER TO OFFER ANY ASSISTANCE NEEDED. THE PUMP LISTED IN THIS REPORT WAS RECEIVED BY KORU ON 21-MAR-2024 AND IS PENDING EVALUATION. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955659 ↗
• MalfunctionMar 21, 2024Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5151162 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "SPONTANEOUS. PATIENT REPORTED THAT AFTER LOADING THE 50ML PREPARED SYRINGE OF HIZENTRA INTO FREEDOM PUMP AND TURNING IT ON, THE PUMP WOULD SHOOT THE SYRINGE OUT OF PLACE. THE BLACK TAB WAS PUSHING DOWN TOO FAST. PATIENT ENDED UP MANUALLY PUSHING 100 OUT OF 120ML FOR 2-HOUR INFUSION TO MATCH NORMAL INFUSION TIME. PUMP DEFECTIVE. NO MISSED DOSE OR ADVERSE EVENT REPORTED. PUMP AVAILABLE FOR RETURN. NO FURTHER INFORMATION. INDICATION: COMMON VARIABLE IMMUNODEFICIENCY WITH PREDOMINANT ABNORMALITIES OF B-CELL NUMBERS AND FUNCTION; IMMUNODEFICIENCY WITH INCREASED IMMUNOGLOBULIN [IGM]; PRIMARY PULMONARY HYPERTENSION; NONFAMILIAL HYPOGAMMAGLOBULINEMIA. REPORTED TO (B)(6) BY PT/ CAREGIVER." A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 04-MARCH-2024 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED 07-MARCH-2024 PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951227 ↗
• MalfunctionFeb 22, 2024Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5149840 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "INDICATION: SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN [LGG] SUBCLASSES. UNSOLICITED COMMUNICATION FROM THE PATIENT. PATIENT REPORTED THAT HER FREEDOM60 PUMP IS NOT WORKING. WHEN THE PATIENT TRIED TO START HER INFUSION THE 50/ML SYRINGE WHICH CONTAINED HIZENTRA JUMPED OUT OF PUMP. WHEN THE PATIENT TRIED TO PUT THE SYRINGE BACK INTO THE PUMP, THE TURNING KNOB WAS NOT WORKING. PATIENT HAD BEEN TRYING TO TROUBLE SHOOT WITH THE PUMP FOR ABOUT 3-4 HOURS. PATIENT REPORTED HIZENTRA DOSE WAS MISSED/WASTED DUE TO PUMP FAILURE. PT DID NOT REPORT ANY ADVERSE EVENTS DUE TO DEFECTIVE DEVICE. DEFECTIVE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER. PRODUCT LOT NUMBER IS UNKNOWN. NO ADDITIONAL INFORMATION AVAILABLE. REPORTED TO (B)(6) BY PT/CAREGIVER." A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 29-JAN-2024 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT WAS RECEIVED BY KORU MEDICAL ON 17-JAN-2024. INSPECTION FINDINGS INCLUDE PUMP NOT WINDING, BLACK TAB WILL NOT WIND BACK. KORU MEDICAL IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18763859 ↗
• MalfunctionJan 29, 2024Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT STATING DURING SETUP THE SYRINGE WAS LOADED INTO THE PUMP AND WHEN TURNED ON, THE SYRINGE SHOT OUT OF THE PUMP. ATTEMPTED ANOTHER TIME AND IT HAPPENED AGAIN. NO ONE WAS INJURED. ANOTHER PUMP WAS USED WITHOUT DIFFICULTY. A RETURN MATERIAL AUTHORIZATION WAS OPENED FOR RETURN OF THE PUMP TO KORU MEDICAL FOR EVALUATION. THE PUMP WAS RECEIVED BY KORU MEDICAL ON (B)(6) 2024 AND EVALUATED. THE EVALUATION CONFIRMED THE PUMP HAD A CLEAR CRACK IN THE NOSE OF THE PUMP NEAR WHERE THE LUER DISC WOULD GO AND IS MOST LIKELY THE CAUSE OF THE FAILURE. IT SEEMS TO BE CONSISTENT WITH THE PUMP BEING DROPPED. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597455 ↗
• MalfunctionJan 26, 2024Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5149371 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PATIENT REPORTED A FREEDOM PUMP MALFUNCTION OCCURRED ON (B)(6) 2023. SECOND SYRINGE WAS INFUSING WHEN SYRINGE SNAPPED OUT OF PUMP, AND A "WIRE" FROM INSIDE THE PUMP WAS STICKING OUT. PATIENT LOST APPROXIMATELY 40 ML OF 100 ML INFUSION. UNKNOWN IF PATIENT MISSED A DOSE OR EXPERIENCED AN ADVERSE EVENT. PUMP AVAILABLE FOR RETURN. PUMP SERIAL NUMBER UNKNOWN. NO FURTHER INFORMATION. REPORTED TO CVS/CAREMARK BY HEALTH PROFESSIONAL." GOOD FAITH EFFORTS WERE SENT TO THE INITIAL REPORTER FOR ADDITIONAL INFORMATION REGARDING THE EVENT AND PUMP STATUS. A RESPONSE WAS RECEIVED STATING THE REPORTER DID NOT PROVIDE THE PUMP SERIAL NUMBER AND WE ARE UNABLE TO DETERMINE BASED ON INFORMATION AVAILABLE AS NOTHING HAS BEEN RECEIVED FROM THE PATIENT IN (B)(6) 2023 OR (B)(6) 2024. NO OTHER DETAILS ARE KNOWN. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18589950 ↗
• MalfunctionDec 20, 2023Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5148026 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "SPONTANEOUS REPORT. PATIENT REPORTS FREEDOM PUMP IS BROKEN; MECHANISM THAT HOLDS SYRINGE IS BROKE SO THE SYRINGE SHOOTS OUT OF PUMP AND WILL NOT STAY IN TO ADMINISTER INFUSION. PATIENT WAS NOT CLINICALLY INJURED DUE TO PUMP MALFUNCTION. PATIENT IS ABLE TO COMPLETE INFUSION, WILL MANUALLY PUSH MEDICATION AND CONTACT PHARMACY IF ANY FURTHER ISSUES. PUMP IS AVAILABLE FOR INSPECTION, AND WILL BE REPLACED WITH A NEW PUMP FOR PATIENT'S NEXT INFUSION. SERIAL NUMBER NOT PROVIDED. INDICATION: NONFAMILIAL HYPOGAMMAGLOBULINEMIA. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER." A GOOD FAITH EFFORTS WERE SENT TO THE INITIAL REPORTER ON 01-DEC-2023 AND 07-DEC-2023 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU FOR EVALUATION TO DATE. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PROD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367480 ↗
• MalfunctionNov 30, 2023Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT STATING THE SYRINGE FLEW OUT DURING INFUSION AND THE BLACK TAB WOULDN'T REWIND. NO ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED. GOOD FAITH EFFORTS WERE SENT TO THE INITIAL REPORTER ON (B)(6) 2023, (B)(6) 2023, (B)(6) 2023, AND (B)(6) 2023 FOR ADDITIONAL INFORMATION. RESPONSES WERE RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2023 AND (B)(6) 2023 STATING THE EVENT OCCURRED DURING SET UP OF THE PUMP WHERE THE SYRINGE FLEW OUT OF THE PUMP AFTER LOADING AND THE BLACK TAB WOULD NOT RESET OR MOVE BACK IN ORDER TO REATTEMPT SYRINGE LOAD AFTER INITIAL ISSUE. NO ADVERSE EVENTS OCCURRED. THE PUMP SERIAL NUMBER WAS PROVIDED. THE PATIENT WAS DESCRIBED AS A NEW USER WHO HAS BEEN USING THE PUMP FOR APPROXIMATELY 2 MONTHS. GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON (B)(6) 2023 REGARDING PUMP RETURN. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241537 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162613, K933652. One submission often covers many models, so check the product and lot details in each record.

• Z-0317-2018 · Mar 10, 2016 · Terminated
  Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.