PLEUR-EVAC IPN028441Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 14026704631220), received between Apr 8, 2021 and Sep 13, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (8 reports).

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2021Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  DEFECTIVE PACKAGING SEALING WITH THE COMPROMISE OF STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460522 ↗
• MalfunctionApr 8, 2021Unsealed Device Packaging; Unsealed Device Packaging

  CUSTOMER REPORTED THAT THE SEAL TO THE PRODUCT PACKAGING IS NOT CLOSED. IT IS THE INDIVIDUAL PACKAGING OF EACH PRODUCT. THE PRODUCTS ARE NOT STERILE. CLINICAL CONSEQUENCES: NONE. INCOMING INSPECTION/INVENTORY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11635884 ↗
• MalfunctionApr 8, 2021Unsealed Device Packaging; Unsealed Device Packaging

  CUSTOMER REPORTED THAT THE SEAL TO THE PRODUCT PACKAGING IS NOT CLOSED. IT IS THE INDIVIDUAL PACKAGING OF EACH PRODUCT. THE PRODUCTS ARE NOT STERILE. CLINICAL CONSEQUENCES: NONE. INCOMING INSPECTION/INVENTORY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11635386 ↗
• MalfunctionApr 8, 2021Unsealed Device Packaging; Unsealed Device Packaging

  CUSTOMER REPORTED THAT THE SEAL TO THE PRODUCT PACKAGING IS NOT CLOSED. IT IS THE INDIVIDUAL PACKAGING OF EACH PRODUCT. THE PRODUCTS ARE NOT STERILE. CLINICAL CONSEQUENCES: NONE. INCOMING INSPECTION/INVENTORY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11635365 ↗
• MalfunctionApr 8, 2021Unsealed Device Packaging; Unsealed Device Packaging

  CUSTOMER REPORTED THAT THE SEAL TO THE PRODUCT PACKAGING IS NOT CLOSED. IT IS THE INDIVIDUAL PACKAGING OF EACH PRODUCT. THE PRODUCTS ARE NOT STERILE. CLINICAL CONSEQUENCES: NONE. INCOMING INSPECTION/INVENTORY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11635300 ↗
• MalfunctionApr 8, 2021Unsealed Device Packaging; Unsealed Device Packaging

  CUSTOMER REPORTED THAT THE SEAL TO THE PRODUCT PACKAGING IS NOT CLOSED. IT IS THE INDIVIDUAL PACKAGING OF EACH PRODUCT. THE PRODUCTS ARE NOT STERILE. CLINICAL CONSEQUENCES: NONE. INCOMING INSPECTION/INVENTORY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11635275 ↗
• MalfunctionApr 8, 2021Unsealed Device Packaging; Unsealed Device Packaging

  CUSTOMER REPORTED THAT THE SEAL TO THE PRODUCT PACKAGING IS NOT CLOSED. IT IS THE INDIVIDUAL PACKAGING OF EACH PRODUCT. THE PRODUCTS ARE NOT STERILE. CLINICAL CONSEQUENCES: NONE. INCOMING INSPECTION/INVENTORY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11635251 ↗
• MalfunctionApr 8, 2021Unsealed Device Packaging; Unsealed Device Packaging

  CUSTOMER REPORTED THAT THE SEAL TO THE PRODUCT PACKAGING IS NOT CLOSED. IT IS THE INDIVIDUAL PACKAGING OF EACH PRODUCT. THE PRODUCTS ARE NOT STERILE. CLINICAL CONSEQUENCES: NONE. INCOMING INSPECTION/INVENTORY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11635227 ↗