HAEMONETICS PCS 2 APHERESIS SYSTEM 06002-220-EXPRecalls & reported problems
Haemonetics Corporation · PCS2, LIST NO. 06002-220-EXP · Class 2
All models of HAEMONETICS PCS 2 APHERESIS SYSTEM (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30812747011956), received between Apr 2, 2021 and Apr 2, 2021 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Blood or Lymphatic problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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