SPUR II Adult ResuscitatorSingle Patient Use ResuscitatorRecalls & reported problems across all models
Ambu A/S · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one SPUR II Adult ResuscitatorSingle Patient Use Resuscitator model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 2
- Injuries reported
- 1
- Recalls
- 1
We found 3 models of SPUR II Adult ResuscitatorSingle Patient Use Resuscitator by Ambu A/S in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2018 and Dec 17, 2021 — classified as 2 deaths, 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
SPUR II Adult ResuscitatorSingle Patient Use Resuscitator recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 9, 2025Class IOpen, Classified
Potential for the manometer port being blocked rendering the manometer non-functional.
Z-2181-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported SPUR II Adult ResuscitatorSingle Patient Use Resuscitator problems
Device problems
- Detachment of Device or Device Component1
- Disconnection1
- No Flow1
- Pressure Problem1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Death2
- Low Oxygen Saturation2
- Loss of consciousness1
SPUR II Adult ResuscitatorSingle Patient Use Resuscitator models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523611057Ventilator, emergency, manual (resuscitator)1 recall0 reports
- SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520211000Ventilator, emergency, manual (resuscitator)2 reports
- SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520611001Ventilator, emergency, manual (resuscitator)2 deaths2 reports
Recent SPUR II Adult ResuscitatorSingle Patient Use Resuscitator adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 17, 2021Therapeutic or Diagnostic Output Failure
PER MAUDE REPORT: PATIENT WAS IN DIALYSIS RECEIVING HER FIRST INTERMITTENT HEMODIALYSIS RUN AND AN HOUR INTO HER RUN, WENT UNRESPONSIVE. PATIENT STARTED DESATURATING, CLOSE FACE MASK APPLIED AT "FLUSH" RATE. PATIENT STILL UNABLE TO MAINTAIN GOOD SATURATIONS. EMERGENCY AMBU BAG THAT WAS IN ROOM WAS ACCESSED AND HOOKED UP TO OXYGEN, APPLIED OVER MOUTH, HOWEVER THE PATIENT CONTINUED TO DESATURATE DESPITE ATTEMPTING MANUAL BREATHS AND BEING HOOKED UP TO THE OXYGEN THROUGH AMBU BAG TUBING. PATIENT PLACED BACK ONTO CLOSED FACE MASK AND RRT ARRIVED AT BEDSIDE. AMBU BAG WAS HOOKED UP TO ANOTHER OXYGEN TREE IN ANOTHER ROOM TO ASSESS QUALITY AND FUNCTION AND WAS FOUND TO BE MALFUNCTIONED, NOT ALLOWING ANY AIR THROUGH THE MASK.
Patient problems: Loss of consciousness; Low Oxygen Saturation
MAUDE report 13026289 ↗MalfunctionDec 17, 2021No Flow; No Flow
PER MAUDE REPORT: PATIENT WAS IN DIALYSIS RECEIVING HER FIRST INTERMITTENT HEMODIALYSIS RUN AND AN HOUR INTO HER RUN, WENT UNRESPONSIVE. PATIENT STARTED DESATURATING, CLOSE FACE MASK APPLIED AT "FLUSH" RATE. PATIENT STILL UNABLE TO MAINTAIN GOOD SATURATIONS. EMERGENCY AMBU BAG THAT WAS IN ROOM WAS ACCESSED AND HOOKED UP TO OXYGEN, APPLIED OVER MOUTH, HOWEVER THE PATIENT CONTINUED TO DESATURATE DESPITE ATTEMPTING MANUAL BREATHS AND BEING HOOKED UP TO THE OXYGEN THROUGH AMBU BAG TUBING. PATIENT PLACED BACK ONTO CLOSED FACE MASK AND RRT ARRIVED AT BEDSIDE. AMBU BAG WAS HOOKED UP TO ANOTHER OXYGEN TREE IN ANOTHER ROOM TO ASSESS QUALITY AND FUNCTION AND WAS FOUND TO BE MALFUNCTIONED, NOT ALLOWING ANY AIR THROUGH THE MASK.
Patient problems: Low Oxygen Saturation
MAUDE report 13023756 ↗DeathJan 31, 2019Detachment of Device or Device Component; Pressure Problem
PATIENT WAS CODING. RESQPOD (NON AMBU DEVICE WHICH IS AN IMPEDANCE THRESHOLD DEVICE DELIVERING INTRATHORACIC PRESSURE REGULATION THERAPY) WOULD NOT STAY ATTACHED TO AMBU SPUR II RESUSCITATOR DURING USE.
Patient problems: Death
MAUDE report 8292995 ↗DeathDec 13, 2018Disconnection
PATIENT CODING. AMBU SPRU II REMOVED FROM PACKAGING AND PLACED INTO USE. PEEP VALVE DISCONNECTED FROM OUTLET CONNECTOR DURING USE AND RESQPOD (NOT AN AMBU DEVICE) PLACED BETWEEN ET TUBE AND RESUSCITATOR DIS-CONNECTOR FROM PATIENT CONNECTOR ON EVERY BREATH CAUSING THE THERAPISTS TO HOLD THE RESQPOD ONTO THE RESUSCITATOR. THERAPIST SHOULD HOLD THE TUBE WITH SPARE HAND BUT WAS REQUIRED TO KEEP THE RESUSCITATOR, PEEP VALVE AND RESQPOD IN PLACE. PATIENT EXPIRED.
Patient problems: Death
MAUDE report 8163246 ↗
Other Ambu A/S products
All Ambu A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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