Accessories, Blood Circuit, Hemodialysis
FDA adverse event reports and recall history for accessories, blood circuit, hemodialysis (product code KOC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,219
- Deaths
- 17
- Injuries
- 102
- Malfunctions
- 1,084
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 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
- 2006-03-29TerminatedOther
Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3005, 5M3005R
Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system.
- 2004-07-20TerminatedOther
Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816, 1-800-472-5221. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch.
The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
- 2004-07-20TerminatedOther
Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, DCL-800TEC 12 Fr. x 20.3cm, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816, 1-800-472-5221. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch.
The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
- TerminatedDevice Design
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
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