Cartridge Blood Set 101025Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 07332414007836), received between May 29, 2018 and May 6, 2026 — classified as 2 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (62 reports).

3 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

1. Apr 14, 2021Class IITerminated

   There is a potential leak between the venous patient connector and patient's hemodialysis access.

   Z-1684-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 30, 2020Class IIOpen, Classified

   complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

   Z-1118-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Apr 17, 2020Class IITerminated

   Potential disconnection of tubing set.

   Z-2193-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE BROKEN CASSETTE OF A GAMBRO CARTRIDGE LINE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25101375 ↗
• MalfunctionApr 13, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE "BROKEN LINE" OF A GAMBRO CARTRIDGE SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865287 ↗
• MalfunctionAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK ALONG THE VENOUS LINE OF THE CASSETTE WAS OBSERVED FROM A GAMBRO CARTRIDGE SET AT THE TIME OF PATIENT CONNECTION FOR HEMODIALYSIS THERAPY. THE SET WAS REPLACED TO CONTINUE TREATMENT. 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 22903589 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE BACK OF THE CASSETTE OF A GAMBRO CARTRIDGE SET DURING HEMODIALYSIS THERAPY. 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 22038475 ↗
• MalfunctionFeb 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE ACCESS SAMPLE SITE OF A GAMBRO CARTRIDGE SET FIVE (5) MINUTES AFTER THE START OF HEMODIALYSIS THERAPY. AIR WAS ALSO PRESENT IN THE ACCESS LINE. THE VOLUME OF BLOOD LOSS WAS APPROXIMATELY 190ML. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314513 ↗
• MalfunctionFeb 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A GAMBRO CARTRIDGE SET DURING HEMODIALYSIS THERAPY. THE ABSENCE OF A ¿SAMPLE COLLECTION PORT¿ ON THE SET WAS OBSERVED. THE BLOODLINES WERE REPLACED TO CONTINUE TREATMENT. 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 21298025 ↗
• MalfunctionJan 27, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL LEAK OF SALINE SOLUTION WAS OBSERVED FROM A BREAKAGE IN A GAMBRO CARTRIDGE SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21245750 ↗
• MalfunctionJan 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE VENOUS LINE OF GAMBRO CARTRIDGE SET DURING HEMODIALYSIS THERAPY. THE VOLUME OF BLOOD LOSS WAS LES THAN 150ML. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21214461 ↗
• MalfunctionJan 7, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE VENOUS CONNECTION PORT OF THE PATIENT LINE OF A GAMBRO CARTRIDGE SET. THE VENOUS LINE THREAD DID NOT TIGHTEN PROPERLY. THE VOLUME OF BLOOD LOSS WAS APPROXIMATELY 10ML. THE BLOOD WAS RETURNED TO THE PATIENT AND THE LINES WERE REPLACED TO CONTINUE TREATMENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096191 ↗
• MalfunctionOct 30, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM A "SMALL FISSURE" IN THE BLOOD PUMP SEGMENT OF A GAMBRO CARTRIDGE SET DURING HEMODIALYSIS THERAPY. THE TREATMENT WAS ENDED WITHOUT BLOOD RESTITUTION. THE VOLUME OF BLOOD LEAKAGE WAS NOT GREATER THAN 20CC. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566847 ↗
• MalfunctionMay 7, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL LEAK OF SALINE SOLUTION WAS OBSERVED FROM A CRACK IN A GAMBRO CARTRIDGE SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259873 ↗
• MalfunctionFeb 5, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT AN EXTERNAL LEAK OF SALINE SOLUTION WAS OBSERVED FROM THE ¿PERFORATED¿ LINE OF A GAMBRO CARTRIDGE SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18646543 ↗
• MalfunctionDec 27, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A CRACK IN THE CASSETTE OF A GAMBRO CARTRIDGE WHICH RESULTED IN AN EXTERNAL SALINE LEAK. THE LEAK WAS DISCOVERED WHILE PRIMING THE SET PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400311 ↗
• MalfunctionNov 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  UPON FURTHER INFORMATION, THE CUSTOMER CONFIRMED THERE WAS NO LEAKAGE FROM THE CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046924 ↗
• MalfunctionOct 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING FROM THE VENOUS CHAMBER OF A GAMBRO CARTRIDGE SET DURING PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030435 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL FLUID LEAK (SALINE SOLUTION) WAS OBSERVED ORIGINATING FROM THE BLOOD PUMP SEGMENT TUBING OF A GAMBRO CARTRIDGE DN PRIME LINE DURING PRIME. UPON FURTHER INSPECTION, ¿A CASSETTE FISSURE¿ WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858294 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED AN EXTERNAL FLUID LEAK (SALINE SOLUTION) WAS OBSERVED ORIGINATING FROM A CUT BLOOD PUMP SEGMENT TUBING OF A GAMBRO CARTRIDGE DN PRIME LINE DURING PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858119 ↗
• MalfunctionSep 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL SALINE LEAK WAS OBSERVED ORIGINATING IN THE VENOUS CHAMBER OF A GAMBRO CARTRIDGE. THE UNSPECIFIED DIALYSIS MACHINE WAS TURNED OFF AND THE SET WAS REPLACED. THE REPORTER STATED ¿MANUAL BLOOD RETURN WAS PERFORMED¿; HOWEVER, THE EVENT OCCURRED DURING PRIME. THEREFORE, THE EVENT OCCURRED DURING AN UNKNOWN PROCESS 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 17817683 ↗
• MalfunctionSep 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING FROM THE VENOUS CHAMBER OF A GAMBRO CARTRIDGE SET DURING PRIME. PRIMING WAS STOPPED, THE CASSETTE WAS CHANGED, AND PRIMING WAS RESUMED WITHOUT FURTHER INCIDENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17803763 ↗
• MalfunctionAug 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED IN A GAMBRO CARTRIDGE SET DURING PRIME. WHEN THE CASSETTE WAS REMOVED ¿FROM THE HYDROPHOBIC ONES, IT WAS NOTICED THAT A PIECE OF THE CASSETTE WAS ADHERED TO THE WALL OF THE MACHINE¿ AND ¿THE SALINE SOLUTION BEGAN TO SPREAD ON THE PART OF THE CASSETTE OF THE GAMBRO LINE¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595734 ↗
• MalfunctionAug 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM THE CASSETTE TUBING (BLOOD PUMP SEGMENT) OF A GAMBRO CARTRIDGE DURING HEMODIALYSIS THERAPY. TREATMENT WAS ENDED WITHOUT BLOOD RESTITUTION AND THE ACCUMULATED BLOOD LOST WAS MORE THAN 150ML. 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 17585833 ↗
• MalfunctionAug 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING FROM THE CASSETTE OF A GAMBRO CARTRIDGE DN PRIME LINE DURING PRIME. THE EVENT OCCURRED WHEN REMOVING THE CASSETTE FROM THE HYDROPHOBES AND A PIECE OF THE CASSETTE WAS STUCK TO THE WALL OF THE MACHINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542303 ↗
• InjuryJul 17, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT 15 MINUTES AFTER STARTING TREATMENT WITH A CARTRIDGE LINE, AN EXTERNAL BLOOD LEAK BETWEEN THE ARTERIAL PATIENT LINE AND THE ARTERIAL INJECTION PORT WAS OBSERVED. IT WAS FURTHER REPORTED AN ALARM WAS GENERATED. ACCORDING TO THE REPORTER IT WAS ¿A CLEAN CUT¿ AND ¿THE TUBING JUST CUT OFF AND THE PATIENT STARTED BLEEDING OUT". THE BLOOD LOSS WAS 700-1000 ML. NO CLINICAL SYMPTOMS WERE REPORTED; HOWEVER, ¿EXTRA FLUID¿ WAS ADMINISTERED TO THE PATIENT PRIOR TO LEAVING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17333452 ↗
• MalfunctionJun 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL SALINE LEAK WAS OBSERVED ORIGINATING FROM THE ¿WALLS OF THE CASSETTE¿ OF A GAMBRO CARTRIDGE DN PRIME LINE DURING PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182245 ↗
• MalfunctionMay 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS FLUID LEAK FROM THE BACK OF THE VENOUS CHAMBER OF A GAMBRO CATRIDGE. THE LEAK WAS FURTHER DESCRIBED AS, ¿WHEN PLACING THE CASSETTE AND PRIMING IT, A VERY FINE AND CONTINUOUS LIQUID JET WAS OBSERVED COMING OUT FROM THE BACK OF THE VENOUS CHAMBER, AROUND THE CIRCLE FORMED WHERE THE MACHINE'S SENSOR IS INSERTED¿. THIS ISSUE WAS OBSERVED DURING PRIMING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020252 ↗