Cartridge Blood Set 103401Recalls & reported problems
Gambro Renal Products, S.A. de C.V. · The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Gambro Cartridge Blood Set is the tubing and blood chamber set used once for a single hemodialysis treatment with Phoenix dialysis machines. The 33 reports mostly describe leaking or cracking of the set during priming, before it was connected to the patient, with a few mentioning blood leaking during treatment. There are no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07332414007867), received between May 30, 2019 and Nov 8, 2024 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (29 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak29
- Break5
- Crack4
- Device Contamination with Chemical or Other Material2
- Material Separation2
- Air/Gas in Device1
- Detachment of Device or Device Component1
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A GAMBRO CARTRIDGE SET LEAKED ¿IN THE CARTRIDGE CONNECTION LINE TUBE AREA¿ DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20644870 ↗MalfunctionOct 2, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT A GAMBRO CARTRIDGE LINE WAS DAMAGED AND LEAKED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350706 ↗MalfunctionAug 23, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT A GAMBRO CARTRIDGE SET WAS CRACKED AND LEAKED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20057005 ↗MalfunctionMay 6, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE "ARTERIAL CHAMBER AREA" OF A GAMBRO CARTRIDGE EXTENSION DIALYZER LINE WAS DAMAGED AND LEAKED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19248379 ↗MalfunctionMar 29, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A GAMBRO CARTRIDGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19006200 ↗MalfunctionAug 10, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING AT THE JUNCTION OF THE ARTERIAL SERVICE LINE AND THE CHAMBER OF A GAMBRO CARTRIDGE EXT. DIALYZER LINE DURING PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17497523 ↗MalfunctionJul 25, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED DUE TO A ¿CRACK ON THE CARTRIDGE¿ OF A GAMBRO CARTRIDGE EXT. DIALYZER DURING PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17389220 ↗MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED DUE TO A LOOSE HEPARIN LINE OF A GAMBRO CARTRIDGE EXT. DIALYZER LINE DURING HEMODIALYSIS THERAPY. THE VOLUME OF BLOOD LOST WAS NOT REPORTED. THE SET WAS REPLACED, AND THERAPY WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17299085 ↗MalfunctionMay 23, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM ¿THE CONNECTION PART OF THE A CHAMBER¿ OF A GAMBRO CARTRIDGE EXT. DIALYZER LINE SET APPROXIMATELY ¿20 TO 30 MINUTES¿ INTO HEMODIALYSIS THERAPY. THE VOLUME OF BLOOD LOSS WAS REPORTED AS ¿VERY LITTLE¿. TREATMENT WAS DISCONTINUED, EXTRACORPOREAL BLOOD WAS RETURNED TO THE PATIENT AND THERAPY WAS RESTARTED WITH A NEW SET. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16989943 ↗MalfunctionMay 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING FROM LINE VENOUS PORT OF A GAMBRO CARTRIDGE EXT. DIALYZER LINE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16852703 ↗MalfunctionApr 4, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED PARTICULATE MATTER WAS OBSERVED IN THE ARTERIAL CHAMBER OF A GAMBRO CARTRIDGE LINE. THIS EVENT WAS NOTED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16674961 ↗MalfunctionDec 19, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT DURING PRIMING WITH A CARTRIDGE DIALYZER LINE, AN EXTERNAL FLUID LEAK AND A BREAKAGE WAS OBSERVED AT THE CHAMBER SIDE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16004468 ↗MalfunctionDec 5, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT DURING PRIMING WITH A CARTRIDGE DIALYZER LINE, AN EXTERNAL SALINE LEAK FROM THE ¿NORMAL SALINE LINE¿ WAS OBSERVED. IT WAS FURTHER REPORTED THE HEPARIN CONNECTION PORT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15916252 ↗MalfunctionOct 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PRIMING WITH A CARTRIDGE DIALYZER LINE, A BLACK FOREIGN MATTER WAS OBSERVED INSIDE THE LINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15690618 ↗MalfunctionAug 15, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT DURING TREATMENT WITH A CARTRIDGE DIALYZER LINE, AN EXTERNAL BLOOD LEAK OCCURRED, FOLLOWING A DISCONNECTION BETWEEN THE ARTERIAL BLOOD LINE AND ARTERIAL INJECTION PORT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15224147 ↗MalfunctionAug 2, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT DURING PRIMING WITH A CARTRIDGE LINE DIALYZER, AN EXTERNAL FLUID LEAK AND A CRACK WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15147304 ↗MalfunctionApr 14, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED ON ONE UNIT OF A GAMBRO CARTRIDGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14116532 ↗MalfunctionApr 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING PATIENT TREATMENT WITH A CARTRIDGE LINE DIALYZER, AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE ARTERIAL CHAMBER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14106549 ↗MalfunctionMar 24, 2022Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING PATIENT TREATMENT WITH A GAMBRO CARTRIDGE SET, THE CONNECTION BETWEEN THE TUBING AND A LOOSE CHAMBER WAS OBSERVED WHICH RESULTED IN AN EXTERNAL BLOOD LEAK AND BLOOD LOSS (AMOUNT UNKNOWN). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13893564 ↗MalfunctionMar 10, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AS SOON AS TREATMENT STARTED, AN EXTERNAL BLOOD LEAK WAS OBSERVED ON A GAMBRO CARTRIDGE DIALYZER FROM THE ARTERIAL CHAMBER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13723620 ↗MalfunctionFeb 7, 2022Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED ON ONE UNIT OF GAMBRO CARTRIDGE DURING PRIMING. IT WAS OBSERVED THAT THE CHAMBER WAS CRACKED ON THE DIALYZER LINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13476619 ↗MalfunctionJan 21, 2022Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT DURING TREATMENT WITH A CARTRIDGE DIALYZER LINE, AN EXTERNAL BLOOD LEAK OCCURRED BETWEEN THE ARTERIAL PATIENT LINE AND INJECTION PORT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13315249 ↗MalfunctionAug 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, AFTER TREATMENT WITH A GAMBRO CARTRIDGE EXT DIALYZER, THE VENOUS PATIENT CONNECTOR BECAME DETACHED FROM THE VENOUS BLOOD LINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12281832 ↗MalfunctionMay 28, 2021Break; Air/Gas in Device; Break; Air/Gas in Device
IT WAS REPORTED THAT AIR BUBBLE WAS OBSERVED IN THE VENOUS PATIENT LINE OF A GAMBRO CARTRIDGE EXT DIALYZER DUE TO A CRACK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11901802 ↗MalfunctionMay 14, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT SHORTLY AFTER STARTING TREATMENT WITH A GAMBRO CARTRIDGE EXT DIALYZER, AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM A BROKEN VENOUS PATIENT CONNECTOR. THE PATIENT LOST 3CC OF BLOOD. EXTRACORPOREAL BLOOD WAS RETURNED TO THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11825692 ↗
Other SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE devices
- Hemodialysis Bloodlines SL-2010M2096B. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve3 recalls3 deaths1,000 reports
- Hemodialysis Bloodlines SL-2010M2096AB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve2 recalls1 death483 reports
- Hemodialysis Bloodlines SL-2000M2095DAB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve2 recalls1 death214 reports
- CombiSet 03-2722-9Fresenius Medical Care Holdings, Inc. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE8 deaths311 reports
- Hemodialysis Bloodlines SL-2000M2095B. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve1 recall219 reports
- CombiSet 03-2522-1Fresenius Medical Care Holdings, Inc. · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve1 recall214 reports
- Cartridge Blood Set 101025Gambro Renal Products, S.A. de C.V. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE3 recalls80 reports
- Hemodialysis Bloodlines SL-2000M2095DB. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve1 recall158 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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