MedStream MS930Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842472100730), received between Mar 13, 2025 and Jul 31, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

188 other recalls cover devices cleared under the same FDA submission (K964435); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED ON AN UNKNOWN DATE REGARDING A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER WHERE THE REPORTER REPORTED THAT AFTER STARTING THE IV AND ATTACHING THE TUBING TO THE HUB, THE APPARATUS MALFUNCTIONED WITH BLOOD COMES UP THE TUBING. THEY STATED THAT "THE 1ST TIME IT HAPPENED, I THOUGHT I HAD MISTAKENLY HIT AN ARTERY. IT BECOMES AN ISSUE WHEN I FLUSH THE LINE. FLUID "SQUIRTS" OUT OF THE EXTENSION FROM THE BLUE CLAMP END. IT APPEARS TO BE WHERE THE DISTAL PART OF THE TUBING ATTACHES TO THE CLAMP." THEY REPORTED THAT THEY TRIED TO CHANGE THE CLAMP PIECE, BUT IT STILL OCCURRED. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22679653 ↗
• MalfunctionMay 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING THE 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER THAT EXPERIENCED LEAKAGE. THE REPORTER STATED THAT A FEW OF THE PRODUCT WAS LEAKING WITH IV FLUIDS. IT WAS FURTHER STATED THAT UNKNOWN IV FLUID WAS INVOLVED. THE EVENT DATE WAS ON FEB-2025. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT. UPDATE: THE ONE LEAKY EXAMPLE THEY KEPT (THERE WERE 4-5 OCCURRENCES) WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107166 ↗
• MalfunctionMar 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER WAS FOUND TO HAVE LEAKED DURING PATIENT USE. IT WAS REPORTED THAT THE EXTENSION LOCKS ARE LEAKING AT THE PORT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610611 ↗
• MalfunctionMar 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE, A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER WAS FOUND TO HAVE LEAKED DURING PATIENT USE. IT WAS REPORTED THAT THE EXTENSION LOCKS ARE LEAKING AT THE PORT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610541 ↗
• MalfunctionMar 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER WAS FOUND TO LEAK DURING PATIENT USE. IT WAS REPORTED THAT THE EXTENSION LOCKS ARE LEAKING AT THE PORT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610414 ↗
• MalfunctionMar 13, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV CLAVE¿, CLAMP, ROTATING LUER WAS FOUND TO HAVE A CRACK RESULTING IN A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THE END OF THE TUBING WAS CRACKED AND WHEN THEY FLASHED SALINE THE EXTENSION SET EITHER DRIPPED OR SPRAYED OUT. THERE WAS NO PATIENT HARM REPORTED. THE INITIAL REPORTER INDICATED THAT THE EVENT OCCURRED THREE TIMES; HOWEVER, NO ADDITIONAL INFORMATION WAS GIVEN PERTAINING TO THE ADDITIONAL INSTANCES. A SEARCH OF THE COMPLAINT DATABASE SHOWED NO PRIOR REPORT OF THESE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21602155 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0234-2021 · Jul 6, 2020 · Terminated
  47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01
• Z-0195-2021 · Jul 6, 2020 · Terminated
  109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotati
• Z-0223-2021 · Jul 6, 2020 · Terminated
  26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The I
• Z-0233-2021 · Jul 6, 2020 · Terminated
  139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)1088
• Z-0227-2021 · Jul 6, 2020 · Terminated
  142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948
• Z-0232-2021 · Jul 6, 2020 · Terminated
  58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460
• Z-0202-2021 · Jul 6, 2020 · Terminated
  8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(

…and 173 more.