NATURA 404592Recalls & reported problems

Summary

The FDA's MAUDE database contains 907 adverse event reports that list this exact device (DI 00768455104529), received between Nov 13, 2018 and Sep 25, 2026 — classified as 1 injury, 906 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (906 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 907 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of (b)(6) from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895632 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895631 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of (b)(6) from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895630 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895624 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895623 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895621 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895620 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895619 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895618 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895617 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of (b)(6) from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895616 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895614 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895612 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895611 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895609 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895607 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895606 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895603 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895602 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895600 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895598 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895562 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895560 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895559 ↗
• MalfunctionSep 25, 2026Malposition of Device

  The reporter stated that the wafer opening was off-center. A total of fifty wafers from six boxes of the same lot were affected, with only ten wafers considered usable. The reporter was unable to provide the exact quantity affected per market unit. She reported having experienced the same issue previously indicated that off-center openings had resulted in decreased wear time in the past, prompting her to inspect wafers prior to use. None of the affected wafers were used due to concerns regarding reduced wear time. The photographs were received from the complainant depicting the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895558 ↗