Apparatus, Autotransfusion
Anesthesiology · 21 CFR 868.5830
Recent MDR events
3,163 adverse event reports on file
- AUTOLOG IQJul 30, 2026MalfunctionPerfusion Systems2184009-2026-01182
- AUTOLOG WASH KITJul 16, 2026MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2026-04378
- AUTOLOG IQJul 13, 2026MalfunctionPerfusion Systems2184009-2026-00839
- AUTOLOG WASH KITJul 9, 2026MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2026-04223
- AUTOLOG IQJul 7, 2026MalfunctionPerfusion Systems2184009-2026-00698
- AUTOLOG ONE SOURCE PACKJul 2, 2026MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2026-04098
- AUTOLOG IQJul 1, 2026MalfunctionPerfusion Systems2184009-2026-00679
- AUTOLOG IQJul 1, 2026InjuryPerfusion Systems2184009-2026-00680
- AUTOLOG IQJul 1, 2026MalfunctionPerfusion Systems2184009-2026-00683
- AUTOLOG WASH KITJun 29, 2026MalfunctionMedtronic Mexico S. De R.l. De Cv9617601-2026-04013
Event type breakdown
Recalls
89 recall events for this product code
- Maquet Cardiovascular, LLCOpen, ClassifiedJan 12, 2024
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
Z-0709-2024 · View FDA record ↗ - Maquet Cardiovascular, LLCOpen, ClassifiedJan 12, 2024
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
Z-0710-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedDec 28, 2023
Atrium Oasis Drain Single W / AC, Part No. 3600-100
A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.
Z-0621-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedDec 2, 2023
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
Z-0486-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedNov 16, 2023
Ocean Water Seal Chest Drains (Ocean):
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
Z-0316-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedNov 16, 2023
Oasis Dry Suction Water Seal Chest Drains (Oasis):
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
Z-0317-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedNov 16, 2023
Express Dry Seal Chest Drains (Express):
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
Z-0318-2024 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMay 1, 2015
3/16 in. Curved Trocar with Wound Drain
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Z-1570-2015 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMay 1, 2015
1/8 in. Curved Trocar with Wound Drain
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Z-1571-2015 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMay 1, 2015
1/4 in. Curved Trocar with Wound Drain
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Z-1572-2015 · View FDA record ↗
Registered firms
160 firms currently registered for this product code
Midwest Sterilization Corp.
LAREDO, TX, US
Avent S. De R.l. De C.v.
TIJUANA Baja California, MX
Haemonetics Corporation
Boston, MA, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Fresenius Hemocare Gmbh
Friedberg Hesse, DE
Fenwal, Inc.
LAKE ZURICH, IL, US
Sterigenics Us Llc
Grand Prairie, TX, US
Midwest Sterilization Corp.
JACKSON, MO, US
Medtronic Perfusion Systems
Minneapolis, MN, US
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Miller Technical Services
Plymouth, MI, US
Andersen Scientific, Inc.
Morrisville, NC, US
Isomedix Operations Inc.
SAN DIEGO, CA, US
Kawasumi Laboratories (thailand) Co., Ltd.
CHOK CHAI Nakhon Ratchasima, TH
Livanova Deutschland Gmbh
MUNCHEN Bavaria, DE
Bioprod D.o.o.
Ljubljana, SI
Centerpiece S. De R.l De C.v (sterilization Site)
Tijuana Baja California, MX
510(k) clearances
195 clearances for this product code
- Sorin Group Italia S.R.L.Aug 16, 2024
K241236 · XTRA Collection sets; XTRA Sequestration set X
- Inquis MedicalMay 14, 2024
K240426 · Aventus Clot Management System
- Sorin Group Italia S.R.L.Apr 29, 2024
K240584 · XTRA Autotransfusion System (with XTRA Bowl sets)
- Inari Medical, Inc.Jul 14, 2023
K231782 · FlowSaver Blood Return System (80-101)
- Inari Medical, Inc.Feb 17, 2023
K221483 · FlowSaver Blood Return System
- Haemonetics CorporationNov 15, 2022
K221722 · Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
- Atrium Medical CorporationSep 3, 2021
K201305 · Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
- Sisu Global HealthJul 29, 2021
K210862 · Hemafuse System