Cartridge Blood Set 114435Recalls & 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 System from Rev. SW 3.40. The Low Weight - Low Volume model is used when a low extracorporeal blood volume is recommended. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07332414112400), received between Jul 24, 2018 and Jul 24, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
2 FDA recall records name this device's identifier, 1 still open.
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.
Recalls naming this device
- Dec 30, 2020Class IIOpen, Classified
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Z-1123-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 17, 2020Class IITerminated
Potential disconnection of tubing set.
Z-2196-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Loose or Intermittent Connection1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT AT THE BEGINNING OF PATIENT TREATMENT WITH A GAMBRO CARTRIDGE LOW WEIGHT/LOW VOLUME BLOODLINE, THE BLOOD PUMP WAS NOT CATCHING THE TUBING. THE TUBING SEGMENT BECAME LOOSE. THE RN TRIED TO ADJUST THE TUBING, HOWEVER, IT WOULD NOT STAY IN PLACE. TREATMENT WAS TERMINATED WITHOUT RETURNING THE EXTRACORPOREAL BLOOD TO THE PATIENT. THE BLOOD LOSS WAS APPROXIMATELY ESTIMATED TO 50ML. NO CLINICAL SYMPTOMS WERE REPORTED; HOWEVER, THE PATIENT HAD AN "ER VISIT". IT WAS UNKNOWN IF ANY MEDICAL INTERVENTION WAS PROVIDED. AT THE TIME OF THIS REPORT, THE PATIENT WAS ¿STABILIZED¿. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Blood Loss
MAUDE report 7713456 ↗
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page