ReNew 3622Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00811099010142), received between May 23, 2018 and May 21, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Break; Break

  DISPOSABLE RENEW SUPER ATRAUMATIC GRABBER TIP BROKE INTO TWO PIECES INSIDE THE PATIENT'S ABDOMEN. THE BROKEN GRASPER CAUSED RETRACTION OF BOWEL TO BE LOST DUE TO INABILITY TO GRASP. ONE SMALL PIECE OF GRASPER FELL FREELY INTO PATIENT'S ABDOMEN. THE PIECE WAS RETRIEVED BY THE SURGEON WITH USE OF LAPAROSCOPE GUIDANCE AND NEW GRASPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060238 ↗
• MalfunctionMar 13, 2025Fracture; Fracture

  DURING A ROBIC CASE ST NOTICED THE BLACK PIECE OF THE MICROLINE TIP FELL OFF INTO THE PATIENT'S ABDOMEN. THE PIECE WAS REMOVED & THE SUPPLY WAS REMOVED FROM THE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595574 ↗
• MalfunctionFeb 7, 2025Fracture; Fracture

  AFTER SURGERY, IT WAS THE STERILE STAFF WHO DISCOVERED THAT A RUBBER PART FROM A GRABBER TIP WAS ON ANOTHER INSTRUMENT. THE RUBBER PROBABLY CAME LOOSE WHEN THEY TOOK OUT THE FORCEPS WITH THE GRABBER TIP AND WHEN THEY DROVE DOWN A LAPAROSCOPIC NEEDLE DRIVER (IN THE TROCAR), THE RUBBER PIECE HAD GOTTEN STUCK THERE. NO DAMAGE WAS DONE AND THE SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334129 ↗
• MalfunctionJun 4, 2024Fracture; Fracture

  HEAT SHRINK FELL OFF INTO PATIENT ABDOMEN-NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462144 ↗
• MalfunctionMay 23, 2018Material Separation; Material Separation

  THE HEAT SHRINK OF THE ATRAUMATIC GRASPER TIP FELL OFF INTO THE PATIENT. THE PIECE WAS RETRIEVED. THE ANESTHESIA TIME WAS NOT EXTENDED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7537066 ↗