Pall Conserve™ Small Volume HME BB25ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00636207000231), received between Nov 30, 2017 and Jul 13, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Inaccurate Delivery” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K791307); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2018Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT A PALL ULTIPOR 25 BREATHING SYSTEM FILTER WAS IN USE AND AFTER 20 MINUTES IN THEATRE UNDER STANDARD LOW FLOW CONDITIONS, IT WAS NOTICED THAT THE REQUIRED FLOW RATE COULD NOT BE DELIVERED TO THE PATIENT. AFTER SWITCHING FROM LARYNGEAL MASK AIRWAY TO ENDOTRACHEAL INTUBATION, RE-ADJUSTMENT OF VENTILATOR SETTINGS, THE PATIENT REANIMATION WAS STARTED, WHICH WAS POSSIBLE AFTER THE FILTER WAS REMOVED. THE HOSPITAL HAS REPORTED TO PALL THAT THE PATIENT IS IN ICU, AT THIS STAGE THE PROGNOSIS IS UNKNOWN. THE PATIENT IS UNDER MECHANICAL VENTILATION AND NOT RESPONSIVE. THE LOT NUMBER OF THE ONE IMPLICATED FILTER IS NOT KNOWN, BUT THE HOSPITAL BELIEVES THAT THE FILTER COULD BE FROM ONE OF THE LAST THREE DELIVERIES THAT THEY RECEIVED. THOSE DELIVERIES WERE FILTERS FROM LOT NUMBERS 731202 (DATE OF MANUFACTURE 07 NOVEMBER 2017), 805202 (DATE OF MANUFACTURE 21 FEBRUARY 2018) AND 810402 (DATE OF MANUFACTURE 16 APRIL 2018). THE HOSPITAL DID ALSO INFORM PALL THAT THE TUBING USED IN THE BREATHING CIRCUIT IS REPROCESSED (WASHING, DISINFECTION, AIR-DRYING). THE HOSPITAL HAVE RETAINED THE FILTER. THEY ARE WAITING FOR AGREEMENT FROM BFARM BEFORE RETURNING THE FILTER TO PALL FOR INVESTI

  Patient problems: Decreased Respiratory Rate

  MAUDE report 7686638 ↗
• InjuryNov 30, 2017Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT A PATIENT WAS UNDER ANESTHESIA WITH A PALL ULTIPOR 25 BREATHING SYSTEM FILTER AND THE USER MONITORED A LEAK ON THE PATIENT BREATHING CIRCUIT. THE CUSTOMER CHECKED THE BREATHING CIRCUIT AND OBSERVED A CRACK IN THE FILTER, SO THEY HAD TO CHANGE IT. NO ADVERSE EFFECTS ON THE PATIENTS WERE REPORTED. THE USER STATED, IN THEIR OPINION, THE LEAK PUT THE PATIENT AT RISK DUE TO INADEQUATE VENTILATION AND ANTI-BACTERIAL FUNCTION OF THE FILTER MIGHT HAVE BEEN AFFECTED. IMPLICATED REORDER CODE (B)(4) IS NOT REGISTERED AND SOLD IN THE US. ALL FDA INFORMATION BELOW IS RELATED TO "LIKE" PRODUCTS, UNDER 510K K791307, WHICH ARE REGISTERED FOR SALE IN THE US.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 7072994 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K791307. One submission often covers many models, so check the product and lot details in each record.

• Z-2038-2014 · Jun 4, 2014 · Terminated
  PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. The filters are individually packaged in a c