GIBECK IPN043751Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04026704348008), received between Jan 24, 2022 and Nov 18, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K965016); 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 16, 2026.

Recalls naming this device

1. Aug 29, 2022Open, Classified

   Incidents of device splitting or detaching during use

   Z-0074-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 29, 2022Open, Classified

   Incidents of device splitting or detaching during use

   Z-0072-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE HME FILTERS ISO-GARD FILTER S SUDDENLY SPLIT DURING OPERATION". FURTHER INFORMATION STATES THAT "THE FILTERS WERE IN USE ONLY A FEW HOURS EACH TIME. IN NO CASE WAS THERE A DROP IN OXYGEN SATURATION OR DAMAGE TO THE PATIENT". SEE ASSOCIATED MDRS 8040412-2022-00318 AND 8040412-2022-00319.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826026 ↗
• MalfunctionNov 18, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE HME FILTERS ISO-GARD FILTER S SUDDENLY SPLIT DURING OPERATION." FURTHER INFORMATION STATES THAT "THE FILTERS WERE IN USE ONLY A FEW HOURS EACH TIME. IN NO CASE WAS THERE A DROP IN OXYGEN SATURATION OR DAMAGED TO THE PATIENT." ASSOCIATED MDRS: 8040412-2022-00316 AND 8040412-2022-00319.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826000 ↗
• MalfunctionNov 18, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE HME FILTERS ISO-GARD FILTER S SUDDENLY SPLIT DURING OPERATION". FURTHER INFORMATION STATES THAT "THE FILTERS WERE IN USE ONLY A FEW HOURS EACH TIME. IN NO CASE WAS THERE A DROP IN OXYGEN SATURATION OR DAMAGE TO THE PATIENT". SEE ASSOCIATED MDRS 8040412-2022-00316 AND 8040412-2022-00318.

  Patient problems: Insufficient Information

  MAUDE report 15825962 ↗
• MalfunctionAug 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT "THE FILTER SPLITS DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224040 ↗
• MalfunctionMar 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT "[THE FILTER] OPENS UNDER TRACTION OF THE COAX TUBE WHICH VENTILATES THE PATIENT". MULTIPLE ATTEMPTS MADE TO CUSTOMER FOR ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL. PATIENT INFORMATION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13844944 ↗
• MalfunctionMar 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT "[THE FILTER] OPENS UNDER TRACTION OF THE COAX TUBE WHICH VENTILATES THE PATIENT". MULTIPLE ATTEMPTS MADE TO CUSTOMER FOR ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL. PATIENT INFORMATION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13844913 ↗
• MalfunctionJan 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT "DURING MASK VENTILATION, IT IS DETECTED THAT AIR IS LEAKING OUT OF THE FILTER. ON CLOSER INSPECTION, YOU CAN SEE THAT THE FILTER HAS OPENED IN THE JOINT". IT WAS REPORTED THAT THE FILTER WAS REPLACED. NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333935 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K965016. One submission often covers many models, so check the product and lot details in each record.

• Z-0076-2023 · Aug 29, 2022 · Open, Classified
  Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
• Z-0077-2023 · Aug 29, 2022 · Open, Classified
  Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
• Z-0073-2023 · Aug 29, 2022 · Open, Classified
  Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
• Z-0075-2023 · Aug 29, 2022 · Open, Classified
  Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,