DARRecalls & reported problems across all models

We found 35 models of DAR by Covidien LP in the FDA's device registry (GUDID). Together they are named in 172 adverse event reports in the FDA's MAUDE database, received between Nov 6, 2017 and Sep 28, 2026 — classified as 1 death, 16 injuries, 155 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (71 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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

DAR 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.

1. Apr 29, 2021Open, Classified

   The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

   Z-1869-2021 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

2. Apr 29, 2021Open, Classified

   The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

   Z-1867-2021 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

3. Apr 29, 2021Open, Classified

   The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

   Z-1866-2021 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported DAR problems

DAR models

35 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DAR 353S19046

  CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
  1 recall1 report
• DAR 350S19006

  Filter, bacterial, breathing-circuit
  1 recall1 report
• DAR 351/5979

  Filter, bacterial, breathing-circuit
  1 recall0 reports
• DAR 444SP02012

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  50 reports
• DAR 354/5876

  CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
  25 reports
• DAR 352/5877

  Filter, bacterial, breathing-circuit
  23 reports
• DAR 444SP02014

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  10 reports
• DAR 350/5879

  Filter, bacterial, breathing-circuit
  1 death8 reports
• DAR 350/5865Z

  Filter, bacterial, breathing-circuit
  7 reports
• DAR 5093600

  Filter, bacterial, breathing-circuit
  5 reports
• DAR 444SP02012

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  5 reports
• DAR 4-076408-00

  Filter, bacterial, breathing-circuit
  3 reports
• DAR 444SP02014

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  3 reports
• DAR 352/5877

  Filter, bacterial, breathing-circuit
  3 reports
• DAR 444SP02012

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  2 reports
• DAR 444SP02014

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  2 reports
• DAR 352/5855

  Filter, bacterial, breathing-circuit
  2 reports
• DAR 610U5257

  CONNECTOR, AIRWAY (EXTENSION)
  2 reports
• DAR 444SP02314

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  2 reports
• DAR 351/5856

  Filter, bacterial, breathing-circuit
  2 reports
• DAR 331/5661

  CONNECTOR, AIRWAY (EXTENSION)
  2 reports
• DAR 351/5410Z

  Filter, bacterial, breathing-circuit
  1 report
• DAR 111P1160

  Circuit, Breathing (W Connector, Adaptor, Y Piece)
  1 report
• DAR 444S02708

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  1 report
• DAR 444SP00412

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  1 report
• DAR 444S02605

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  1 report
• DAR 444SP02010

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  1 report
• DAR 444SP02114

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  1 report
• DAR 444SP02312

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  1 report
• DAR 444S02608

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  1 report
• DAR 444S02708

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  1 report
• DAR 351U5979

  Filter, bacterial, breathing-circuit
  1 report
• DAR 352U5805

  Filter, bacterial, breathing-circuit
  1 report
• DAR 355U5430

  Filter, bacterial, breathing-circuit
  1 report
• DAR 444SP02114

  CATHETERS, SUCTION, TRACHEOBRONCHIAL
  1 report

Recent DAR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break; Obstruction of Flow

  Patient in CTICU "[cardio-thoracic intensive care unit]" underwent bedside percutaneous tracheostomy. The ventilator was plugged into bronch adapter (Covidien DAR connector, REF 610U5257, LOT 25G0004FAX, Exp 7/1/2030) during procedure. Once tracheostomy tube was inserted, we attempted to disconnect vent circuit from the bronch adapter, but the bronch adapter broke off into the vent circuit and could not be removed. Patient was bagged with BVM "[bag-valve-mask]" without any complication and RT "[respiratory therapist]" got new vent circuit. No harm met the patient, but this was a device failure causing obstruction of ventilator tubing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914753 ↗
• MalfunctionApr 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE BREATHING SYSTEM CIRCUIT SET FAILED THE PERFORMED LEAK TEST. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835131 ↗
• MalfunctionApr 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE BREATHING SYSTEM CIRCUIT SET FAILED THE PERFORMED LEAK TEST. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835093 ↗
• MalfunctionMar 31, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE NURSE ROUTINELY REPLACED THE BREATHING CIRCUIT AND VENTILATOR TUBING. ONE HOUR LATER, THE BEDSIDE NURSE DISCOVERED CONDENSATE LEAKING FROM THE CONNECTION BETWEEN THE BREATHING CIRCUIT AND THE ENDOTRACHEAL TUBE, INDICATING POOR SEALING AT THE INTERFACE. THE BREATHING CIRCUIT WAS IMMEDIATELY REPLACED. PATIENT OUTCOME WAS ASKED BUT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24746261 ↗
• MalfunctionMar 17, 2026Crack

  IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621626 ↗
• MalfunctionMar 17, 2026Crack

  IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621588 ↗
• MalfunctionMar 17, 2026Crack

  IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621562 ↗
• MalfunctionMar 17, 2026Crack

  IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621514 ↗
• MalfunctionMar 17, 2026Crack

  IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621471 ↗
• MalfunctionMar 17, 2026Crack

  IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621417 ↗
• InjuryMar 12, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A ROUTINE SYSTEM CHANGE INVOLVING THE CLOSE SUCTION CIRCUIT, A PATIENT EXPERIENCED A DROP IN PERIPHERAL OXYGEN SATURATION DUE TO EXISTING SECRETIONS IN THE LUNGS. AN ATTEMPT WAS MADE TO SUCTION THE SECRETIONS ENDOTRACHEALLY, BUT SUCTION COULD NOT BE GENERATED BECAUSE THE BLUE SUCTION VALVE BUTTON WAS NOT FUNCTIONING. THE PERIPHERAL OXYGEN SATURATION CONTINUED TO FALL. PRE-OXYGENATION WAS PERFORMED, AND SECRETIONS WERE SUBSEQUENTLY REMOVED USING CONVENTIONAL STERILE SUCTIONING, AFTER WHICH OXYGEN SATURATION RETURNED TO NORMAL LEVELS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24583294 ↗
• MalfunctionFeb 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT AN AIR LEAK OCCURRED INVOLVING A CIRCUIT, BREATHING AND FILTER, AND THE LOCATION WAS UNKNOWN PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309151 ↗
• MalfunctionJan 27, 2026Gas/Air Leak

  IT WAS REPORTED THAT A N AIR LEAK WAS DETECTED WHEN THE CIRCUIT WAS CONNECTED TO THE VENTILATOR ALONG WITH THE FILTER AND ADAPTOR PRIOR TO USE. THE ISSUE WAS RESOLVED AFTER THE CIRCUIT REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194046 ↗
• MalfunctionJan 27, 2026Gas/Air Leak

  IT WAS REPORTED THAT A N AIR LEAK WAS DETECTED WHEN THE CIRCUIT WAS CONNECTED TO THE VENTILATOR ALONG WITH THE FILTER AND ADAPTOR PRIOR TO USE. THE ISSUE WAS RESOLVED AFTER THE CIRCUIT REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193956 ↗
• MalfunctionJan 21, 2026Gas/Air Leak

  IT WAS REPORTED THAT LEAKAGE OCCURRED ON THE WHITE ATTACHMENT PIECE TO THE ENDOTRACHEAL TUBE OF THE SUCTION CATHETER, AND NO AIR WAS ENTERING THE LUNGS. THE PROBLEM WAS SOLVED BY CHANGING THE SUCTION SYSTEM. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24140301 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall