HAEMONETICS CELL SAVER ELITE SYSTEM CSE-P-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10812747016537), received between Apr 3, 2020 and Jun 21, 2022 — classified as 9 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Crack” (32 reports).

6 other recalls cover devices cleared under the same FDA submission (K101907); 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2022Infusion or Flow Problem; Infusion or Flow Problem

  ON (B)(6) 2022, HAEMONETICS WAS NOTIFIED OF "FAILURE TO EMPTY 3RD BOWL INTO RBC BAG X 2, NEW BOWL SET LOADED. 4TH BOWL WITH NEW BOWL SET ALSO FAILED TO EMPTY. BLOOD FROM BOTH BOWLS DISCARDED. DONOR TRANSFUSION RECEIVED / QUANTITY: NONE RECEIVED (CONFIRMED (B)(6) 2021). CELL SALVAGE BLOOD RE-INFUSED / VOLUME: 221 ML RE-INFUSED (X 2 FULL BOWLS DISCARDED) - APPROX ANOTHER 225 ML" DURING A PROCEDURE USING A CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET-125M IN THE UNITED KINGDOM. IT WAS DECIDED TO COMMUNICATE AN INITIAL MDR REPORT DUE TO POTENTIAL PROCEDURE DELAY. NO HARM TO THE PATIENT WAS REPORTED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14753976 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, HAEMONETICS WAS NOTIFIED OF AN EARLY WASH TRIGGER WITH AN ESTIMATED BLOOD LOSS APPROXIMATELY 1500 ML (PRE-OP HB/ 97G/DL); CELL SALVAGE BLOOD RE-INFUSED APPROXIMATELY 114 ML DURING A PROCEDURE USING A CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET-125M IN THE (B)(6). THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: Hypovolemia

  MAUDE report 14346133 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, HAEMONETICS WAS NOTIFIED OF AN EARLY WASH TRIGGER WITH AN ESTIMATED BLOOD LOSS APPROXIMATELY 800 ML (PRE-OP HB/ UNKNOWN); CELL SALVAGE BLOOD RE-INFUSED APPROXIMATELY 146 ML DURING A PROCEDURE USING A CELL SAVER® ELITE® PLUS AUTO-TRANSFUSION SYSTEM AND CELL SAVER® ELITE SET-125M IN THE (B)(6). THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: Hypovolemia

  MAUDE report 14339933 ↗
• MalfunctionMar 1, 2022Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2022, HAEMONETICS WAS NOTIFIED OF THE FOLLOWING: BOWL FAILURE ON A 125 ELITE BOWL, THE FAILURE OCCURRED AFTER A NUMBER OF BOWLS PROCESSED, THIS TIME ON THE FIFTH BOWL. AGAIN THE WARNING IS A "LONG EMPTY CYCLE" FOLLOWED BY FLUID IN THE BOTTOM CAVITY OF THE BOWL, DESPITE THE BOWL BEING EMPTY. THIS TIME IT WAS PICKED UP BEFORE THE BOWL SPLIT AND SPILT INTO THE CENTRIFUGE. THIS REQUIRED A CHANGE OUT OF THE PROCESSING KIT MID WAY DURING A PROCEDURE IN AUSTRALIA UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET 125ML. THERE WAS NO REPORTED IMPACT TO THE HEALTH OF THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638564 ↗
• MalfunctionDec 14, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON DECEMBER 08, 2021, HAEMONETICS WAS NOTIFIED OF A FRACTURED LATHAM BOWL AND LEAKED BLOOD IN THE INNER CAVITY DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE FASTPACK - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002180 ↗
• MalfunctionDec 14, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A FRACTURED LATHAM BOWL AND LEAKED BLOOD IN THE INNER CAVITY DURING A PROCEDURE IN AUSTRALIA, UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE FASTPACK 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001847 ↗
• MalfunctionDec 9, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A DAMAGED CONE DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967777 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, HAEMONETICS WAS MADE AWARE OF AN INCIDENT INVOLVING A CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET-125ML. THE DEVICE WAS IN FAT REDUCTION MODE, GAS AND QC SENT. HCT CAME BACK AT 0.114 SO VERY DILUTE AND WAS NOT TRANSFUSED TO THE PATIENT. THE CELL SALVAGED BLOOD WAS DISCARDED AND THE PATIENT REQUIRED AN INTRA-OPERATIVE RBC TX DUE TO THE LOSS OF CELL SALVAGED BLOOD.

  Patient problems: Hypovolemia

  MAUDE report 12927649 ↗
• MalfunctionNov 23, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF BLOOD GOING INTO THE WASTE BAG DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864693 ↗
• MalfunctionNov 18, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A NOISY BOWL ALONG WITH BLOOD MOVING FROM BOWL TO WASTE BAG DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836264 ↗
• MalfunctionOct 26, 2021Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF A LONG EMPTY ERROR MESSAGE FOLLOWING EMPTYING 7TH OR 8TH BOWL IN THE (B)(6), UTILIZING THE CELL SAVER® ELITE PROCESSING SET - 125ML. VOLUME OF BLOOD LOST DUE TO THE LONG EMPTY WAS APPROXIMATELY.125 ML (I.E. THE VOLUME OF THE BOWL THAT WOULDN'T EMPTY). THERE WERE NO OBVIOUS INTERNAL CRACKS SEEN AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12699502 ↗
• MalfunctionSep 28, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF AIR DETECTED EARLY ERROR CODES (122, 130, 280, 161, 115) AND A REQUIRED 9 UNIT TRANSFUSION WHICH OCCURRED DURING A PROCEDURE IN THE (B)(6), UTILIZING THE CELL SAVER® 5 AUTOLOGOUS RECOVERY SYSTEM AND CELL SAVER® 5 SET - 225ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540554 ↗
• InjuryAug 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JULY 27, 2021 HAEMONETICS WAS NOTIFIED OF UNIDENTIFIED BLACK PARTICLES SEEN IN RBC BAG WHICH WAS OBSERVED DURING A PROCEDURE IN THE (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125 ML.

  Patient problems: Unspecified Blood or Lymphatic problem

  MAUDE report 12371310 ↗
• MalfunctionAug 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A DISPOSABLE STRUGGLING TO EMPTY AND A LONG HOUR RETURNING ERROR, UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344473 ↗
• MalfunctionJul 21, 2021Crack; Mechanical Problem; Material Integrity Problem; Crack; Mechanical Problem; Material Integrity Problem

  ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF A LONG HOUR RETURNING ERROR WHICH WAS OBSERVED DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201981 ↗
• MalfunctionJun 8, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A LONG HOUR RETURNING ERROR WHICH WAS OBSERVED DURING A PROCEDURE IN JAPAN, UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11961742 ↗
• MalfunctionJun 8, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A LONG HOUR RETURNING ERROR WHICH WAS OBSERVED DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960071 ↗
• InjuryJun 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON MAY 04, 2021 HAEMONETICS WAS NOTIFIED OF A LONG HOUR RETURNING ERROR WHICH WAS OBSERVED DURING A VASCULAR PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. DURING THE PROCEDURE IT WAS ALSO NOTED THAT THERE WERE PRIOR ERROR MESSAGES OF PRESSURE IN BLUE LINE AND FLUID DETECTED EARLY. THERE WAS 293MLS OF BLOOD WAS LOST, AND PATIENT DID REQUIRE A POST-OPERATIVE TRANSFUSION. CUSTOMER STATED THERE WERE UNABLE TO PROVIDE CURRENT PATIENT HEALTH STATUS DUE TO CONFIDENTIALITY.

  Patient problems: Unspecified Blood or Lymphatic problem

  MAUDE report 11934760 ↗
• MalfunctionMay 28, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A LONG HOUR RETURNING ERROR AND ABNORMAL BLOOD INFLOW IN WASTE LINE WHICH WAS OBSERVED DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11903684 ↗
• MalfunctionMay 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER IN (B)(6) INFORMED HAEMONETICS THE CELL SAVER ELITE DEVICE DISPLAYED A LONG EMPTY ERROR WHILE USING A SIMILAR DEVICE DISPOSABLE SET CELL SAVER ELITE SET - 125ML. THERE WAS NO REPORT OF PATIENT HA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849596 ↗
• InjuryMay 17, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON 21APR2021, HAEMONETICS WAS NOTIFIED OF A LONG EMPTY ALERT ON CYCLE 5 OF A VASCULAR PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML SYSTEM. DURING PROCEDURE 2 UNITS OF DONATED BLOOD WAS NEEDED TO PRECLUDE PERMANENT IMPAIRMENT WHERE IT WOULD NOT HAVE BEEN NEEDED IF THE ISSUE WITH THE DEVICE DID NOT OCCUR. ALTHOUGH IT WAS NOT ABLE TO BE CONFIRMED WITH THE OPERATOR THAT THERE WAS AN INNER CORE LEAK THIS ERROR HAS IN THE PAST BEEN AN INDICATOR OF A POTENTIAL ISSUE WITH THE BOWL THAT HAS BEEN REPORTED. AWAITING LOT NUMBER. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Blood or Lymphatic problem

  MAUDE report 11831914 ↗
• MalfunctionApr 30, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A LONG HOUR RETURNING ERROR WHICH WAS OBSERVED DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER¿ ELITE¿ AUTOTRANSFUSION SYSTEM AND CELL SAVER¿ ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758299 ↗
• MalfunctionMar 21, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON FEBRUARY 22, 2021 HAEMONETICS WAS NOTIFIED OF A LONG HOUR RETURNING ERROR WHICH WAS OBSERVED DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536885 ↗
• MalfunctionMar 18, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A LONG HOUR RETURNING ERROR WHICH WAS OBSERVED AFTER A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11511739 ↗
• InjuryMar 9, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON FEBRUARY 08 2021, HAEMONETICS WAS NOTIFIED OF A LONG EMPTY ALERT ON CYCLE 1 OF A VASCULAR PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML SYSTEM. DURING PROCEDURE FLUID WAS ALSO DETECTED IN THE CENTRIFUGE WELL AND IN THE WASTE BAG. A NEW SET WAS USED TO CONTINUE PROCEDURE, FLUID DETECTED IN CENTRIFUGE WAS AGAIN PRESENT. DUE TO INCIDENT TRANSFUSION WAS NECESSARY, PATIENTS HEALTH STATUS WAS REPORTED AS FINE.

  Patient problems: Unspecified Blood or Lymphatic problem

  MAUDE report 11443258 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101907. One submission often covers many models, so check the product and lot details in each record.

• Z-0896-2020 · Oct 21, 2019 · Terminated
  CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed du
• Z-0894-2020 · Oct 21, 2019 · Terminated
  CS Elite Fastpack, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an ope
• Z-0895-2020 · Oct 21, 2019 · Terminated
  CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an op
• Z-0893-2020 · Oct 21, 2019 · Terminated
  CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an opera
• Z-0892-2020 · Oct 21, 2019 · Terminated
  CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an opera
• Z-0779-2019 · Aug 2, 2017 · Terminated
  Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be