MaxZero MZ9283Recalls & reported problems
BD Switzerland Sàrl · Minibore quad-fuse extension set, 4 IV connectors, 4 check valves 18 cm (7 in) · Class 2
Quick summary
This BD MaxZero Minibore Quad-Fuse extension set is a short IV tubing set with four connectors and four check valves, used to extend and administer intravascular fluids. The 56 reports mostly describe fluid or blood leaking from the set and the tubing cracking, sometimes breaking apart or detaching during use; 11 reports involved injuries and none involved deaths. There are no recalls naming this device. Reports rose sharply, from 4 in the prior 12 months to 16 in the most recent.
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
- 54
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10885403230660), received between Jul 13, 2018 and Jun 17, 2026 — classified as 11 injuries, 43 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak29
- Crack14
- Leak/Splash6
- Break3
- Material Separation2
- Complete Blockage1
- Connection Problem1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient9
- No Known Impact Or Consequence To Patient9
- Unspecified Infection6
- Low Blood Pressure/ Hypotension5
- High Blood Pressure/ Hypertension4
- No Information1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Crack
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS CRACKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED THAT TWO OF THE MAXZERO EXTENSION SET WERE CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25541611 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783713 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783712 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783709 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783707 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783532 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783440 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783119 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783118 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781645 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781644 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781643 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE QUAD-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VARIOUS BD EXTENSION SETS ¿CRACKING¿, DESPITE PAST EDUCATION EFFORTS. TRIFUSE AND QUADFUSE MICROBORE EXTENSION SETS. THERE HAVE BEEN SEVERAL PRODUCTS THAT HAVE BROKEN. MANY DAYS INVOLVED. UNSURE WHAT THE LOT NUMBERS ARE. PACKAGES GET THROWN OUT. THIS HAS BEEN A PROBLEM SINCE WE RECEIVED THE PRODUCT SO IT WOULD SPAN OVER SEVERAL LOT NUMBERS. WE ARE CONCERNED THAT THERE IS AN INCREASED RISK OF BLOODSTREAM INFECTION. ADDITIONALLY, WHEN THEY CRACK IT CAN BE A CHOKING HAZARD FOR PEDIATRIC PATIENTS WHO ARE TOUCHING THEIR CENTRAL LINE OR PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781640 ↗MalfunctionMar 17, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617534 ↗MalfunctionJul 14, 2025Break; Use of Device Problem; Connection Problem; Detachment of Device or Device Component
THERE HAVE BEEN 4 REPORTS OF THE BD MAXZERO QUADFUSE EXTENSION SET CONNECTORS SHATTERING, CRUMBLING, AND BREAKING OFF OF THE SET WHILE DISCONNECTING AND/OR RECONNECTING TO THE LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22493245 ↗MalfunctionJul 11, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE INCIDENT OF A THE MAX ZERO CONNECTOR BECOMING DISCONNECTED FROM EXTENSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484894 ↗MalfunctionFeb 19, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE INCIDENTS OF 4-WAY CONNECTOR BLOCKING AND UNABLE TO BE FLUSHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21414235 ↗MalfunctionFeb 10, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21351848 ↗MalfunctionFeb 5, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR LUER LOK BROKE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: THE LEUR LOCK ON THE 4 LUMEN Y TUBING FREQUENTLY CRACKS AND BREAKS PUTTING PATIENTS AT RISK FOR INFECTION OR DISCONNECTION OF CRITICAL MEDICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18646246 ↗MalfunctionFeb 2, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: VERBATIM: OVER THE WEEKEND, WE HAD A PATIENT¿S QUAD-FUSE BECOME DISCONNECTED ON MORE THAN ONE OCCASION WHERE IT CONNECTS TO A PIECE OF EXTENSION TUBING ON A CENTRAL LINE. HAVE YOU HEARD OF THIS HAPPENING BEFORE? AND IF SO, WHAT HAVE OTHER PLACES DONE TO ALLEVIATE THIS PROBLEM? THE REFERENCE # ON THE PRODUCT IS MZ9283 AND THE LOT # IS 22129236, IF EITHER OF THOSE WOULD BE HELPFUL. THIS IS THE SUB FOR OUR NORMAL QUAD-FUSE EXTENSION SETS. APPRECIATE YOUR HELP!
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18632634 ↗MalfunctionJan 18, 2024Break; Break
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18536077 ↗MalfunctionJan 18, 2023Break; Break
IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR QUAD-FUSE BROKE MIDWAY THROUGH THE FLUSHING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "QUADFUSE BROKE MIDWAY THROUGH FLUSHING AND HANGING NEW LINES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16200458 ↗MalfunctionNov 9, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAVE BEEN A FEW SCENARIOS WHERE RNS HAVE NOTICED FLUID LEAKING NEAR THE MAX ZERO SITE. THE RNS THIS HAS HAPPENED TO EXPLAINED THAT THEIR CONNECTIONS WERE TIGHT SO I AM NOT SURE HOW THE LEAKING WOULD OCCUR, BUT JUST WANTED TO PICK YOUR BRAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12781237 ↗InjuryApr 2, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 1 EXT MINIBORE QUAD-FSEE, 4IV CNNTRS.4CKVS LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "OUR RESUSCITATION DEPARTMENT REPORTED 2 EVENTS WITH POTENTIALLY SERIOUS CONSEQUENCES RELATED TO THE 4-WAY CONNECTORS REFERENCE (B)(4). TWICE THERE WAS A LEAK IN THE AMINE PATHWAY LEADING TO PATIENT FAILURE. FOR THE 2ND REPORT ON (B)(6) 2021, A LEAK WAS NOTED WHICH PERSISTED AFTER THE TRACK WAS TIGHTENED. IN BOTH CASES THE BATCH NUMBER IS NOT KNOWN BUT THE DEVICES HAVE BEEN KEPT."
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 11608845 ↗MalfunctionApr 2, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 1 EXT MINIBORE QUAD-FSEE, 4IV CNNTRS.4CKVS LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "OUR RESUSCITATION DEPARTMENT REPORTED 2 EVENTS WITH POTENTIALLY SERIOUS CONSEQUENCES RELATED TO THE 4-WAY CONNECTORS REFERENCE MZ9283. TWICE THERE WAS A LEAK IN THE AMINE PATHWAY LEADING TO PATIENT FAILURE. FOR THE FIRST REPORT ON (B)(6), 2001, IT WAS NOTED THAT THE THREAD WAS CROOKED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11608844 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.