Dextile DXT1612ALRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521726543), received between Oct 30, 2020 and Apr 1, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN THE MESH WAS TAKEN OUT OF THE PACKAGING, THERE WAS A DAMAGED ON THE EDGES. THE DAMAGED MESH WAS NOT USED AND THE SURGEON USED A NEW DEVICE AND SUTURED THE INCISION TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13981459 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER 3 WEEKS FOLLOWING A LAPAROSCOPIC UNILATERAL INGUINAL HERNIA REPAIR PROCEDURE, A BIG SEROMA WAS SEEN DURING A FOLLOW UP VISIT ALONG WITH A RECURRENT HERNIA. A REOPERATION WAS DONE TO RESOLVE THE RECURRENT HERNIA AND THE PATIENT WAS REHOSPITALIZED.

  Patient problems: Hernia; Seroma

  MAUDE report 13471780 ↗
• MalfunctionOct 30, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL, THE MESH WAS DAMAGED WHEN THE SURGEON ATTEMPTED TO INSERT IT THROUGH THE ROBOTIC 8MM TROCAR. THE MESH WAS NOT IMPLANTED. THE SURGEON USED A LARGER DIAMETER TROCAR AND ANOTHER MESH WAS SUCCESSFULLY IMPLANTED AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10760048 ↗