HAEMONETICS CELL SAVER ELITE SYSTEM CSE-P-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10812747016520), received between Mar 4, 2020 and Mar 4, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020, A CUSTOMER INFORMED HAEMONETICS OF ADVERSE EVENT THAT OCCURRED DURING A SURGERY FOR CONGENITAL CARDIOPATHY. THE CUSTOMER REPORTED THAT THERE WAS AN AUDIBLE NOISE DURING THE PROCEDURE AND PROCEDURE WAS STOPPED IMMEDIATELY. IN ADDITION, PLASTIC DUST WAS FOUND ON THE BOWL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9787998 ↗

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-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-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-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-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-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-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