HAEMONETICS CELL SAVER 5/5+ SYSTEMS 00261-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10812747016124), received between Sep 29, 2020 and Feb 4, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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.

• InjuryFeb 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JANUARY 06, 2021, HAEMONETICS WAS NOTIFIED OF A BOWL LEAK WHICH OCCURRED DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM AND LOW VOL(125ML) CS5 SET. AN ERROR CODE OF 21 AND 24 WAS DISPLAYED DURING PROCEDURE. THERE WAS A BLOOD LOSS REPORTED OF 800ML WITH THE FIRST LOW VOL(125ML) CS5 SET UTILIZED THEN 300ML OF BLOOD LOST WITH THE SECOND LOW VOL(125ML) CS5 SET OF THE SAME LOT. DUE TO THE AMOUNT OF BLOOD LOSS A BLOOD TRANSFUSION WAS NECESSARY.

  Patient problems: Unspecified Blood or Lymphatic problem

  MAUDE report 11278294 ↗
• MalfunctionOct 20, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF A LONG HOUR RETURNING MESSAGE WHICH WAS DISPLAYED DURING A PLASTIC SURGERY PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM AND LOW VOL(125ML) CS5 SET. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10704085 ↗
• MalfunctionSep 29, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ON AUGUST 05, 2020 HAEMONETICS WAS NOTIFIED OF AN INNER CORE LEAK WHICH WAS OBSERVED DURING A PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM AND LOW VOL(125ML) CS5 SET. THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10598623 ↗

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-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-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-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-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-0501-03 · Dec 17, 2002 · Terminated
  Haemonetics High Speed Cell Saver Bowl Set List Number: 263
• Z-0500-03 · Dec 17, 2002 · Terminated
  Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261
• 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-0499-03 · Dec 17, 2002 · Terminated
  Haemonetics Cell Saver 5 Fast Pack with Filtered Reservoir List Number: 260F
• Z-0503-03 · Dec 17, 2002 · Terminated
  Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number: 265F