Instavac IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00628101609504), received between Jan 9, 2023 and Jan 9, 2023 — classified as 1 death.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

1 other recall cover devices cleared under the same FDA submission (K933902); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJan 9, 2023Mechanical Jam; Suction Failure; Mechanical Jam; Suction Failure

  COMPLAINT (B)(4) WAS RECEIVED ON DECEMBER 8, 2022 WHICH STATED "UNIT WAS BROUGHT IN DURING A CODE AND WAS NOT OPERATIONAL/ NO POWER. ANOTHER WORKING UNIT WAS BROUGHT IN."

  Patient problems: Airway Obstruction

  MAUDE report 16126927 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933902. One submission often covers many models, so check the product and lot details in each record.

• Z-0482-2022 · Nov 16, 2021 · Open, Classified
  Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a componen