Accessories, Blood Circuit, Hemodialysis
FDA adverse event reports and recall history for accessories, blood circuit, hemodialysis (product code KOC), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 1,220
- Deaths
- 17
- Injuries
- 102
- Malfunctions
- 1,085
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-09-02Open, ClassifiedComponent change control
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- 2026-09-02Open, ClassifiedComponent change control
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- 2026-09-02Open, ClassifiedComponent change control
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- 2026-09-02Open, ClassifiedComponent change control
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- 2017-03-24TerminatedProcess control
Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.
A customer relayed a complaint of a leaking dialysis tubing connector.
- 2015-06-05TerminatedUnder Investigation by firm
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber
- 2015-02-03TerminatedDevice Design
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.
Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
- 2013-03-18TerminatedProcess control
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
The recalled product leaks at the connection site.
- 2009-01-23TerminatedProcess control
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device
Port may crack and separate resulting in potential blood exposure/blood loss for the patient
- 2009-01-23TerminatedProcess control
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2794-0 Bonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device
Port may crack and separate resulting in potential blood exposure/blood loss for the patient
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