HAEMONETICS PCS 2 APHERESIS 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
- 42
- Deaths reported
- 23
- Injuries reported
- 4
- Recalls
- 0
We found 4 models of HAEMONETICS PCS 2 APHERESIS SYSTEM by Haemonetics Corporation in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2017 and Nov 26, 2024 — classified as 23 deaths, 4 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (12 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
Reports received per month, all models
Most reported HAEMONETICS PCS 2 APHERESIS SYSTEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Overheating of Device12
- Insufficient Device Problem Information9
- No Apparent Adverse Event3
- Appropriate Device Problem Term/Code Not Available1
- Increase in Pressure1
- Smoking1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Death7
- Cardiovascular Dysfunction/Insufficiency2
- Hemolysis1
- High Blood Pressure/ Hypertension1
- Insufficient Information1
- No Code Available1
- Sudden Cardiac Death1
HAEMONETICS PCS 2 APHERESIS SYSTEM models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HAEMONETICS PCS 2 APHERESIS SYSTEM 06002-110-EXP-EWSeparator, automated, blood cell, diagnostic16 deaths30 reports
- HAEMONETICS PCS 2 APHERESIS SYSTEM 06002-110-NA-EWSeparator, automated, blood cell, diagnostic6 deaths10 reports
- HAEMONETICS PCS 2 APHERESIS SYSTEM 06002-220-EXPSeparator, automated, blood cell, diagnostic1 report
- HAEMONETICS PCS 2 APHERESIS SYSTEM 06002-110-EXS-EWSeparator, automated, blood cell, diagnostic1 death1 report
Recent HAEMONETICS PCS 2 APHERESIS SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MANNER OF DEATH REPORTED AS NATURAL. IMMEDIATE CAUSE OF DEATH WAS REPORTED AS DISSECTION OF THE THORACIC AORTA AND CONTRIBUTORY CAUSE OF DEATH WAS SUSPECTED HYPERTENSIVE CARDIOVASCULAR DISEASE PER HAMILTON COUNTY CORONER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20788242 ↗DeathNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS BEING SUBMITTED TO ALIGN WITH CUSTOMER REPORTING REQUIREMENTS. THE USE OF THE HAEMONETICS MEDICAL DEVICE IN THE DONATION PROCEDURE IS NOT SUSPECTED TO HAVE RESULTED IN THE ADVERSE OUTCOME OF THE DONOR. CUSTOMER MADE HAEMONETICS AWARE THAT A 61-YEAR-OLD MALE DONOR PASSED AWAY ON (B)(6) 2024 FROM AN APPARENT HEART ATTACK. THE CENTER HAS NO INFORMATION FROM ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL AS THE DONOR PASSED AWAY THE DAY AFTER THE DONATION, AT THE HOUSE OF A FRIEND. THE DONOR DID NOT EXPERIENCE A REACTION OR ADVERSE EVENT AND THERE WERE NO ERRORS ON THE MACHINE OR ISSUES REPORTED WITH THE DISPOSABLES DURING THE DONOR'S LAST DONATION ON (B)(6) 2024. THE AUTOPSY REPORT IS PENDING TOXICOLOGY RESULTS.
Patient problems: Cardiovascular Dysfunction/Insufficiency
MAUDE report 20773990 ↗DeathNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS BEING SUBMITTED TO ALIGN WITH CUSTOMER REPORTING REQUIREMENTS. THE USE OF THE HAEMONETICS MEDICAL DEVICE IN THE DONATION PROCEDURE IS NOT SUSPECTED TO HAVE RESULTED IN THE ADVERSE OUTCOME OF THE DONOR. CUSTOMER MADE HAEMONETICS AWARE THAT A 42-YEAR-OLD FEMALE DONOR PASSED AWAY IN HER RESIDENCE ON (B)(6) 2024 FROM A HYPERTENSIVE CARDIOVASCULAR DISEASE PER THE MEDICAL EXAMINER. AN AUTOPSY WAS NOT PERFORMED. THE CENTER HAS NO INFORMATION FROM ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL. THE DONOR DID NOT EXPERIENCE A REACTION OR ADVERSE EVENT AND THERE WERE NO ERRORS ON THE MACHINE OR ISSUES REPORTED WITH THE DISPOSABLES DURING THE DONOR'S LAST DONATION ON (B)(6) 2024.
Patient problems: Cardiovascular Dysfunction/Insufficiency
MAUDE report 20763564 ↗DeathOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS BEING SUBMITTED TO ALIGN WITH CUSTOMER REPORTING REQUIREMENTS. THE USE OF THE HAEMONETICS MEDICAL DEVICE IN THE DONATION PROCEDURE IS NOT SUSPECTED TO HAVE RESULTED IN THE ADVERSE OUTCOME OF THE DONOR. ON SEPTEMBER 6, 2024, CUSTOMER MADE HAEMONETICS AWARE THAT A 40-YEAR-OLD MALE DONOR PASSED AWAY ON (B)(6) 2024. THE DONOR WAS FOUND NEAR HIS HOUSE UNCONSCIOUS AND THE CAUSE OF DEATH IS A HEART ATTACK AS REPORTED BY A FAMILY MEMBER. CUSTOMER HAS NO INFORMATION FROM THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL AS DEATH OCCURRED OFF-SITE FROM THE DONATION CENTER. AN AUTOPSY FROM THE MIAMI-DATE MEDICAL EXAMINER HAS NOT BEEN MADE AVAILABLE TO THE CUSTOMER. DONOR'S LAST DONATION OCCURRED ON (B)(6) 2024 AND THERE WERE NO REPORTED ISSUES WITH THE EQUIPMENT OR DISPOSABLES USED IN THE PROCEDURE AT THE TIME OF THE DONATION. THE DONOR DID NOT EXPERIENCE A REACTION OR ADVERSE EVENT DURING THE (B)(6) 2024 PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20359180 ↗DeathSep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS BEING SUBMITTED TO ALIGN WITH CUSTOMER REPORTING REQUIREMENTS. THE USE OF THE HAEMONETICS MEDICAL DEVICE IN THE DONATION PROCEDURE IS NOT SUSPECTED TO HAVE RESULTED IN THE ADVERSE OUTCOME OF THE DONOR. ON SEPTEMBER 4, 2024, CUSTOMER MADE HAEMONETICS AWARE THAT A 72-YEAR-OLD FEMALE DONOR PASSED AWAY ON (B)(6) 2024 FROM AN UNKNOWN CAUSE AS REPORTED BY ANOTHER DONOR. DONOR'S LAST DONATION OCCURRED ON (B)(6) 2024; SHE WAS A FIRST-TIME DONOR. DURING THE DONATION PROCESS, THE NEEDLE BECAME DISLODGED, RESULTING IN BLEEDING. THE DONOR DID NOT RECEIVE A RESTICK, HAD LESS THAN 200 ML CELL LOSS AND DID NOT EXPERIENCE A DAE. THE CENTER PROVIDED DONOR WITH ELECTROLYTE SOLUTION AND HAD DONOR WAIT 15 MINUTES. DONOR STATED THAT SHE WAS FEELING WELL PRIOR TO EXITING THE CENTER. PER DISTRICT 19 MEDICAL EXAMINERS OFFICE SERVING (B)(6), THE DEATH WAS REPORTED FROM (B)(6) HOSPITAL. CUSTOMER HAS NO INFORMATION FROM THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR HEALTH CARE PROFESSIONAL REGARDING THE EVENT. NO AUTOPSY OR TOXICOLOGY TESTING WAS PERFORMED BY THE MEDICAL EXAMINER SERVING (B)(6). THE MEDICAL EXAMINER'S OFFICE DEEMED THE DONOR'S DEATH "NON-ME" AND DECLINED JURISDI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20313918 ↗DeathSep 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 24 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS¿2 PLASMA COLLECTION SYSTEM. THE DONOR DID NOT EXPERIENCE ANY ISSUES, EVENTS OR ALARMS DURING DONATION PROCEDURE. THERE WERE NO ISSUES NOTED WITH THE DISPOSABLES DURING THE DONATION PROCEDURE. THE PLASMA DONATION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 690 ML OF PLASMA COLLECTED. DONOR HAS PREVIOUSLY DONATED WITH NO REACTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12421334 ↗DeathJul 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 48 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WERE NO DIFFICULTIES NOTED DURING PROCEDURE. THE CAUSE OF DEATH IS UNKNOWN AS THE AUTOPSY RESULTS ARE PENDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12245628 ↗DeathJul 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY UTILIZING THE PCS¿2 PLASMA COLLECTION SYSTEM.
Patient problems: Insufficient Information
MAUDE report 12202090 ↗DeathJul 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON JUNE 03, 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH OCCURRED WITHIN 24 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. ALTHOUGH DONATION WAS COMPLETED SUCCESSFULLY, DONOR DID EXPERIENCE A HIGH PRESSURE RETURN. POST DONATION DONOR HAD EXPERIENCED A MEDICAL EMERGENCY IN THE CENTERS PARKING LOT. THE DONOR WAS TRANSMITTED TO THE HOSPITAL VIA AMBULANCE WHERE THE DONOR EXPERIENCED A FULL CARDIAC ARREST AND DIED THE SAME DAY. THERE IS NO AUTOPSY REPORT AVAILABLE AT THIS TIME.
Patient problems: High Blood Pressure/ Hypertension
MAUDE report 12120062 ↗InjuryJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF TRANSIENT ISCHEMIC ATTACK SYMPTOMS WHICH WAS OBSERVED POST PROCEDURE UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE COLLECTION WAS COMPLETE WITH NO ERRORS OR EXCEPTIONS. POST PROCEDURE DONOR REPORTED EXPERIENCING RIGHT SIDE FACIAL NUMBNESS AND TINGLING. UPON EVALUATION CENTER STAFF MEMBER OBSERVED THAT DONOR WAS EXPERIENCING RIGHT SIDED FACIAL DROOPING AND SLURRED SPEECH. THE DONOR WAS THEN TRANSPORTED TO THE HOSPITAL VIA AMBULANCE. BASED ON EVALUATION FROM PHYSICIAN DONORS SYMPTOMS WERE NOT RELATED TO STROKE, DONOR WAS LATER DISCHARGED FROM THE HOSPITAL.
Patient problems: Transient Ischemic Attack
MAUDE report 12093827 ↗DeathJun 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON MAY 19, 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 24 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS¿2 PLASMA COLLECTION SYSTEM. THE WERE NO ERRORS OBSERVED DURING DONATION. THE CAUSE OF DEATH IS UNKNOWN AND IT IS ALSO UNKNOWN IF AN AUTOPSY WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12026333 ↗DeathJun 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON MAY 18, 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 48 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE WERE NO ERRORS OBSERVED DURING DONATION. THE CAUSE OF DEATH IS UNKNOWN AND IT IS ALSO UNKNOWN IF AN AUTOPSY WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12020289 ↗MalfunctionMay 2, 2021Thermal Decomposition of Device; Thermal Decomposition of Device
ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF A SCREW LOOSE WHICH BURNT THE BOARD IN THE PCS®2 PLASMA COLLECTION SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11758842 ↗InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2021 HAEMONETICS WAS NOTIFIED OF HIGHER RETURN PRESSURE WHICH OCCURRED AT THE END OF A DONATION IN (B)(4), UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE DONATION WAS STOPPED DUE TO THE BLOOD IN THE TUBE BEING VISCOUS. SHORTLY AFTER PROCEDURE WAS STOPPED OPERATOR NOTICED THAT THE COLLECTED PLASMA OF APPROX. 230ML WAS CLOTTED. DONOR WAS SENT TO THE HOSPITAL AND WAS RELEASED THE SAME DAY, THERE WERE NO ABNORMAL FINDINGS.
Patient problems: Unspecified Blood or Lymphatic problem
MAUDE report 11609351 ↗InjuryFeb 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ON JANUARY 8, 2021, HAEMONETICS WAS NOTIFIED OF A DONOR FATALITY WHICH HAD OCCURRED WITHIN 48 HOURS OF THE DONOR'S LAST PLASMA DONATION PROCEDURE, UTILIZING THE PCS®2 PLASMA COLLECTION SYSTEM. THE PLASMA COLLECTION PROCEDURE WAS COMPLETED SUCCESSFULLY, NO DONOR REACTIONS OR ALARMS ENCOUNTERED. THE PCS®2 PLASMA COLLECTION SYSTEM COLLECTED 825ML PLASMA. THE DONOR HAD COMPLETED SEVERAL PREVIOUS DONATIONS, WITH 7 DEFERRALS DUE TO HIGH BLOOD PRESSURE. THE CENTER WAS NOTIFIED BY A RELATIVE OF THE PASSING, THE CAUSE OF DEATH WAS UNKNOWN AND AN AUTOPSY REPORT WAS NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11289020 ↗
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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