HAEMONETICS CELL SAVER ELITE SYSTEMRecalls & reported problems across all models
Haemonetics Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 61
- Deaths reported
- 2
- Injuries reported
- 15
- Recalls
- 0
We found 4 models of HAEMONETICS CELL SAVER ELITE SYSTEM by Haemonetics Corporation in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2017 and Jun 21, 2022 — classified as 2 deaths, 15 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Crack” (36 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 HAEMONETICS CELL SAVER ELITE SYSTEM problems
Device problems
- Crack36
- Fluid/Blood Leak32
- Insufficient Device Problem Information9
- Adverse Event Without Identified Device or Use Problem5
- Material Integrity Problem3
- Infusion or Flow Problem2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Known Impact Or Consequence To Patient9
- Unspecified Blood or Lymphatic problem7
- Hypovolemia3
- Death2
- Blood Loss1
- Hemorrhage/Blood Loss/Bleeding1
- Sudden Cardiac Death1
HAEMONETICS CELL SAVER ELITE SYSTEM models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HAEMONETICS CELL SAVER ELITE SYSTEM CSE-P-125Apparatus, Autotransfusion47 reports
- HAEMONETICS CELL SAVER ELITE SYSTEM CSE-P-225Apparatus, Autotransfusion11 reports
- HAEMONETICS CELL SAVER ELITE SYSTEM CSE-E-USApparatus, Autotransfusion2 deaths2 reports
- HAEMONETICS CELL SAVER ELITE SYSTEM CSE-P-70Apparatus, Autotransfusion1 report
Recent HAEMONETICS CELL SAVER ELITE SYSTEM adverse event reports
The 15 most recent reports across all models, 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 ↗InjurySep 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A LONG EMPTY ALARM WITH WASTE CONTAMINATION WHICH OCCURRED DURING A PROCEDURE IN THE UNITED KINGDOM, UTILIZING THE CELL SAVER® 5 AUTOLOGOUS RECOVERY SYSTEM AND CELL SAVER® 5 SET - 225ML. THE CELL SALVAGE BLOOD WAS REINFUSED AND APPROXIMATELY 600ML WAS DISCARDED. DONOR TRANSFUSION WAS RECEIVED.
Patient problems: Unspecified Blood or Lymphatic problem
MAUDE report 12541506 ↗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 ↗MalfunctionSep 24, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A INNER CORE LEAK WHICH WAS OBSERVED DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 225ML. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12530679 ↗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 ↗
Other Haemonetics Corporation products
All Haemonetics Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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