MaxPlus, MaxGuard MX9175Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885403237676), received between Jul 1, 2021 and Oct 9, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2023Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: MX9175, BATCH #: 23099344. IT WAS REPORTED BY CUSTOMER THAT THEY KNOW OF 2 SO FAR ¿ TODAY IN OR 4 AND (B)(6) REPORTED ONE IN CATH LAB. VERBATIM: THIS IS DR. WOOD¿S ORIGINAL NARRATIVE. WE¿VE ENCOUNTERED A COUPLE INSTANCES OF OCCLUSIONS OF OUR IVF RECENTLY. IT TOOK A BIT OF TROUBLESHOOTING, BUT BRIAN S. AND I WERE ABLE TO NARROW THE PROBLEM DOWN TO THE PROXIMAL PORT ON THE EXTENSION TUBING PORTION OF OUR IVF SET UPS (PORT NEAREST THE PATIENT). WHEN AN INFUSION IS PLUGGED INTO THAT PORT, A TOTAL OCCLUSION OF THE LINE HAS OCCURRED TO THE POINT WHERE YOU CAN¿T PUSH ANYTHING/SQUEEZE CHAMBER ¿ FUNCTIONALLY AS IF THE IV IS CLAMPED. WE WERE ABLE TO SOLVE THE PROBLEM BY A) REMOVING THE INFUSION AND B) CHANGING OUT THE EXTENSION TUBING. I¿M NOT SURE IF THIS IS A PROBLEM WITH A PARTICULAR LOT, RANDOM OCCURRENCES, OR RELATED TO THE PLUM PUMP TUBING. PLEASE KEEP AN EYE OUT FOR THESE ISSUES AND NOTIFY THE TECHS IF YOU ENCOUNTER THIS. (B)(6) ¿ CAN YOU GUYS PLEASE KEEP A TALLY IF THIS KEEPS HAPPENING? I KNOW OF 2 SO FAR ¿ TODAY IN OR 4 AND (B)(6) REPORTED ONE IN CATH LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17902328 ↗
• MalfunctionSep 25, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET WITH STANDARD NEEDLELESS CONNECTOR WAS BLOCKED DUE TO THE PROXIMAL PORT CREATING A VACUUM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PROXIMAL PORT ON THE EXTENSION PORT IT WON'T RUN, IT'S CREATING A VACCUM FLUID NOT RUNNING THROUGH IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814268 ↗
• MalfunctionSep 25, 2023Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION WAS PROVIDED.MAT#: MX9175. BATCH#: 22099394, 22019434, 22109067.IT WAS REPORTED BY CUSTOMER THAT PROXIMAL PORT ON THE EXTENSION PORT IT WON'T RUN, IT'S CREATING A VACUUM FLUID NOT RUNNING THROUGH IT. VERBATIM:COMPLAINT RECEIVED VIA EMAIL. EMAIL(S) ATTACHED. PROXIMAL PORT ON THE EXTENSION PORT IT WON'T RUN, IT'S CREATING A VACCUM FLUID NOT RUNNING THROUGH IT. 3 DIFFERENT LOYTS HAVING THIS ISSUELOT #'S 22099394,22019434,22109067.(B)(6) 2023LOT 22019434 IS NOT PART OF THIS COMPLAINT. I FORWARDED YOUR EMAIL TO THE INDIVIDUAL WHO REPORTED THE ISSUES TO ME. I AM WAITING ON THEIR RESPONSE. ADDITIONALLY I WAS OUT OF THE OFFICE FOR A SHORT TIME DUE TO ILLNESS WHICH IS CONTRIBUTING TO THE DELAY IN RESPONDING.(B)(6) 2023AND I HAVE NO IDEA THE LOT NUMBER OF THE TUBING. IT WAS TUBING THAT CAME WITH THE PATIENT FROM PREP.THE INCIDENT THAT I ENCOUNTERED OCCURRED ON 9/7. XXXX EXPERIENCED A SIMILAR ISSUE PRIOR TO THIS, BUT I DO NOT KNOW WHAT DAY.WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED?THE PROBLEM OCCURRED DURING USE, AFTER INDUCTION OF ANESTHESIA.WAS THERE ANY PATIENT INVOLVEMENT?THE TUBING/IV FLUID WAS CONNECTED TO A PATIENT. THIS WAS AFTER INDUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814266 ↗
• MalfunctionSep 25, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET WITH STANDARD NEEDLELESS CONNECTOR WAS BLOCKED DUE TO THE PROXIMAL PORT CREATING A VACUUM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PROXIMAL PORT ON THE EXTENSION PORT IT WON'T RUN, IT'S CREATING A VACCUM FLUID NOT RUNNING THROUGH IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814265 ↗
• MalfunctionAug 25, 2023Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WITH STANDARD NEEDLESS CONNECTOR WOULD NOT PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MY CARDIAC CATH LAB TEAM HAS ESCALATED A SECOND TIME THEIR CONCERN WITH THE TUBING BELOW NOT PRIMING. THE PRODUCT IS MX9175, LOT # 23019031. SHE SAID THAT DURING CASES THIS WEEKEND THE FUNCTIONALITY WAS HIT OR MISS. WHEN THEY COULDN'T GET THE TUBING TO PRIME, THEY JUST KEPT HOOKING UP A NEW SET UNTIL THEY FOUND ONE THAT WOULD PRIME. THIS IS A HUGE WASTE AND DELAYS PATIENT CARE. " RESPONSE RECEIVED ON 08-AUG-2023. ¿ IS THERE SAMPLE AVAILABLE TO RETURN FOR EVALUATION? IF NO, CAN A PHOTO BE PROVIDED? A PICTURE AND SAMPLES WERE ALREADY SENT ¿ DO YOU NOT HAVE THEM? ¿ WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? NO ¿ WAS THE TUBING STILL COILED WITH TAPE IN PLACE DURING PRIMING/FLUSHING? NO ¿ HOW MUCH FLUID IS IN THE DRIP CHAMBER PRIOR TO PRIMING THE REST OF THE SET? I MEAN THIS HAPPENED ON MORE THAN ONE OCCASION SO IM SURE THE AMOUNT IN THE DRIP CHAMBER VARIED BUT TYPICALLY THE NURSES FILL THE DRIP CHAMBER TO ABOUT HALF FULL PRIOR TO PRIMING. ¿ HOW FAR IN THE BAG IS THE SPIKE? AGAIN, IM SURE THAT THIS VARIED SLIGHTLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627100 ↗
• MalfunctionAug 11, 2023Complete Blockage; Complete Blockage

  MAT#: MX9175 BATCH#: 20096317IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WITH STANDARD NEEDLESS CONNECTOR WOULD NOT PRIME. IT WAS REPORTED BY INITIAL REPORTER THAT: THE EXTENSION TUBING THEY HAD SOMETIMES WON¿T PRIME. THEY¿VE TRIED TAKING THE END CAP OFF THE TUBING AND STILL WON¿T PRIME. VERBATIM: BLOCKAGE ISSUE (COULD NOT PRIME): - ARE YOU ABLE TO PROVIDE THE DATE OF EVENT IN FORMAT DD-MMM-YYYY? 07/24/2023 - HOW MANY DEFECTIVE SET(S) AFFECTED IN THIS INCIDENT? UNKNOWN - WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? DURING USE - WAS THERE ANY PATIENT INVOLVEMENT? TUBING HAD TO BE REPLACED DURING CARE - ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO - WHAT WAS THE PATIENT OUTCOME? ANTICIPATED OUTCOME - WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT? DELAY IN CARE - WHAT PROCEDURE WAS BEING PERFORMED? CARDIAC CATH LAB PREP. FLUIDS WERE BEING HUNG IN THE PREP AREA. - WHAT MEDICATION WAS USED IN THE PROCEDURE? NORMAL SALINE - WAS THERE ANY MEDICAL INTERVENTION DUE TO THIS EVENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17511144 ↗
• MalfunctionAug 8, 2023Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT MAXGUARD EXTENSION SET WITH STANDARD NEEDLESS CONNECTOR THAT TUBING WAS NOT PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY INITIAL REPORTER AND THE VERBATIM: "MY CARDIAC CATH LAB TEAM HAS ESCALATED A SECOND TIME THEIR CONCERN WITH THE TUBING BELOW NOT PRIMING. THE PRODUCT IS MX9175, LOT # 23019031. SHE SAID THAT DURING CASES THIS WEEKEND THE FUNCTIONALITY WAS HIT OR MISS. WHEN THEY COULDN¿T GET THE TUBING TO PRIME THEY JUST KEPT HOOKING UP A NEW SET UNTIL THEY FOUND ONE THAT WOULD PRIME. THIS IS A HUGE WASTE AND DELAYS PATIENT CARE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484119 ↗
• MalfunctionJun 28, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD MAXGUARD EXTENSION SET WITH STANDARD NEEDLESS CONNECTOR THERE WAS A CLOG. THIS OCCURRED 8 TIMES. THIS IS THE 1ST OF 2 EVENTS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE VALVE AT THE Y-SITE GETS OCCLUDED, RESULTING IN HAVING TO SWITCH OUT THE SET TO ADMINISTER MEDICATIONS. THE BLUE VALVE MECHANISM INSIDE THE NEEDLELESS Y-SITE CONNECTOR APPEARS TO OCCLUDE THE TUBING AT THE Y-SITE CONNECTOR. WE HAVE 3 SETS OF THE TUBING THAT ACTUALLY MALFUNCTIONED TO SEND IN, ALONG WITH PACKAGING, AND TWO UNOPENED SETS FROM THE SAME LOT NUMBER AND BIN IN PACU STORAGE CLOSET. THERE WERE ADDITIONAL SIMILAR REPORTS FROM OR/ANESTHESIA FINDING THE SAME PROBLEM, AND THEY ALSO SAVED ONE OF THE SETS THAT MALFUNCTIONED, AND PACKAGING FROM LOT 22079350 EXP 2025-7-19. WE ALSO HAVE FIVE SAMPLES UNOPENED FROM THIS SAME LOT. AND ANESTHESIA ALSO SAVED THE PACKAGING AND SET FROM ANOTHER SET THAT MALFUNCTIONED FROM LOT 22099394 EXP 2025-09-20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17219483 ↗
• MalfunctionJun 28, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD MAXGUARD EXTENSION SET WITH STANDARD NEEDLESS CONNECTOR THERE WAS A CLOG. THIS OCCURRED 8 TIMES. THIS IS THE 1ST OF 2 EVENTS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE VALVE AT THE Y-SITE GETS OCCLUDED, RESULTING IN HAVING TO SWITCH OUT THE SET TO ADMINISTER MEDICATIONS. THE BLUE VALVE MECHANISM INSIDE THE NEEDLELESS Y-SITE CONNECTOR APPEARS TO OCCLUDE THE TUBING AT THE Y-SITE CONNECTOR. WE HAVE 3 SETS OF THE TUBING THAT ACTUALLY MALFUNCTIONED TO SEND IN, ALONG WITH PACKAGING, AND TWO UNOPENED SETS FROM THE SAME LOT NUMBER AND BIN IN PACU STORAGE CLOSET. THERE WERE ADDITIONAL SIMILAR REPORTS FROM OR/ANESTHESIA FINDING THE SAME PROBLEM, AND THEY ALSO SAVED ONE OF THE SETS THAT MALFUNCTIONED, AND PACKAGING FROM LOT: 22079350 EXP 2025-7-19. WE ALSO HAVE FIVE SAMPLES UNOPENED FROM THIS SAME LOT. AND ANESTHESIA ALSO SAVED THE PACKAGING AND SET FROM ANOTHER SET THAT MALFUNCTIONED FROM LOT: 22099394 EXP 2025-09-20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217033 ↗
• MalfunctionMar 18, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD 32-IN STD BORE SET W/ MAX Y CONN CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE PRIMED PRIOR TO USING ON A PATIENT. THE FLUID WILL FLOW THROUGH OUR PRIMARY LINE BUT WILL NOT FLOW WHEN THE EXTENSION IS PUT ON. MULTIPLE NURSES TRIED UN-ATTACHING AND REATTACHING WITH NO FLOW OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569845 ↗
• MalfunctionDec 5, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD 32-IN STD BORE SET W/ MAX Y CONN THERE WERE FLOW ISSUES AND BLOCKAGES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT: FLUIDS ARE NOT FLOWING THROUGH CORRECTLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916414 ↗
• MalfunctionNov 3, 2022Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD 32-IN STD BORE SET W/ MAX Y CONN THE TUBING WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT IS DEFECTIVE. DETAILS OF COMPLAINT (REPORTED ISSUE): CONCERN DESCRIPTION: PRODUCT FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721589 ↗
• MalfunctionJul 1, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT FLUID WOULDN'T FLOW THROUGH 2 32-IN STD BORE SET W/ MAX Y CONN SETS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUID WON'T FLOW AT ALL"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104193 ↗