HAEMONETICS CELL SAVER 5/5+ SYSTEMS 00263-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10812747016131), received between Jun 25, 2020 and Apr 10, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (1 report).

13 other recalls cover devices cleared under the same FDA submission (K932890); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2021Disconnection; Device Contamination with Body Fluid; Disconnection; Device Contamination with Body Fluid

  ON MARCH 11 2021, HAEMONETICS WAS NOTIFIED OF THE TUBING FROM THE BOWL INLET DISCONNECTING WHICH OCCURRED DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® 5 AUTOLOGOUS RECOVERY SYSTEM AND CELL SAVER® 5 SET - 225ML. THE PROCEDURE WAS UNABLE TO BE DISCONTINUED AS DEVICE WAS CONTAMINATED. THERE WAS NO HARM TO PATIENT OR OPERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646627 ↗
• InjuryMar 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF THE CONNECTING TUBE ABOVE CENTRIFUGE BECAME DETACHED DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® 5 AUTOLOGOUS RECOVERY SYSTEM AND CELL SAVER® 5 SET - 225ML. THE PROCEDURE WAS DISCONTINUED DUE TO DEVICE BEING CONTAMINATED. BLOOD LOSS WAS ESTIMATED AT 1500ML AND PATIENT WAS IN NEED OF A TRANSFUSION. THERE WAS NO HARM TO PATIENT AND OPERATOR WAS WEARING PPE.

  Patient problems: Unspecified Blood or Lymphatic problem

  MAUDE report 11501542 ↗
• InjuryJun 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ON MAY 27 2020 HAEMONETICS WAS NOTIFIED OF AN ADVERSE EVENT WHICH OCCURRED ON THE 1ST CYCLE OF THE PROCESS PHASE DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® 5 AUTOLOGOUS RECOVERY SYSTEM AND CELL SAVER® 5 SET - 225ML. A TOTAL OF 800ML OF BLOOD WAS LOST, PROCEDURE WAS STOPPED IMMEDIATELY AND ALLOGENEIC BLOOD WAS TRANSFERRED TO PATIENT. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: Blood Loss

  MAUDE report 10198045 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932890. One submission often covers many models, so check the product and lot details in each record.

• Z-0888-2020 · Oct 21, 2019 · Terminated
  CS5/5+ Fastpacks, 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 dur
• Z-0886-2020 · Oct 21, 2019 · Terminated
  CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subs
• Z-0887-2020 · Oct 21, 2019 · Terminated
  High Speed Cell Saver5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed du
• Z-0891-2020 · Oct 21, 2019 · Terminated
  Cell Saver5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed duri
• Z-0889-2020 · Oct 21, 2019 · Terminated
  CS5/5+ Fastpacks, 125 mL, 20 Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed durin
• Z-0890-2020 · Oct 21, 2019 · Terminated
  CS5/5+ Fastpacks, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed duri
• Z-0885-2020 · Oct 21, 2019 · Terminated
  CS5/5+ Fastpacks, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed dur
• Z-0502-03 · Dec 17, 2002 · Terminated
  Haemonetics Cell Saver 5 Low Volume (125mL) Fast Pack List Number: 265
• Z-0498-03 · Dec 17, 2002 · Terminated
  Haemonetics Cell Saver 5 Fast Pack List Number: 260
• Z-0501-03 · Dec 17, 2002 · Terminated
  Haemonetics High Speed Cell Saver Bowl Set List Number: 263
• Z-0503-03 · Dec 17, 2002 · Terminated
  Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number: 265F
• Z-0499-03 · Dec 17, 2002 · Terminated
  Haemonetics Cell Saver 5 Fast Pack with Filtered Reservoir List Number: 260F
• Z-0500-03 · Dec 17, 2002 · Terminated
  Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261