ReNew 3222Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00811099010067), received between Jul 2, 2018 and Oct 2, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2025Break; Break

  DURING THE CASE, ONE SIDE OF THE GRASPER TIP SNAPPED OFF INSIDE THE PATIENT. THE SURGEON WAS ABLE TO SAFELY RETRIEVE THE BROKEN PIECE, AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23198471 ↗
• MalfunctionSep 24, 2025Fracture; Fracture

  DAMAGE OCCURRED DURING PROCEDURE WHEN GRASPING A ROBOTIC SPONGE (CIGAR) APPROX.4MM IN THICKNESS. UNABLE TO DETERMINE IF A MICRO PIECE OF METAL IS LOST IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137245 ↗
• MalfunctionMar 24, 2025Fracture; Fracture

  DISPOSABLE TIP WAS NOTICED LOOSE IN THE ABDOMEN. TIP WAS REMOVED BY THE SURGEON ((B)(6)) AND DAMGE TO THE TIP LINER WAS NOTICED, AND REPORTED TO THE LOCAL REP. BATCH IS GOING TO BE REMOVED AND REPLACED AS REPORTED FAULT HAS BEEN SUGGESTED WITH ONE OF THE LOT TIPS - WHICH WAS NOTICEABLY LOOSE UPON INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679335 ↗
• MalfunctionAug 12, 2024Fracture; Fracture

  (B)(6) MEDICAL CENTER HAD A 3222, FENESTRATED GRASPER BREAK WHEN IN USE DURING A PROCEDURE. PART OF THE GRASPER WINGS BROKE APART AND FELL INTO THE PATIENTS ABDOMEN. THE BROKEN PORTION HAD TO BE SEARCHED FOR AND RETRIEVED. ALL BROKEN PORTIONS WERE REPORTED AS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19964940 ↗
• MalfunctionApr 11, 2024Fracture; Fracture

  HEAT SHRINK FELL OFF DURING PROCEDURE INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088096 ↗
• MalfunctionJan 10, 2023Break; Break

  GRASPER BROKE IN HALF IN PATIENT, X-RAY WAS DONE AND ALL PIECES WERE REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131399 ↗
• MalfunctionSep 9, 2022Break; Break

  HEAT SHRINK FELL OFF DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393574 ↗
• MalfunctionMar 1, 2021Fracture; Fracture

  ONE SIDE OF THE GRASPER BROKE OFF IN PATIENT DURING LAPAROSCOPIC CASE. IT WAS A CLEAN BREAK AND ONE PIECE WAS RETRIEVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396096 ↗
• MalfunctionSep 11, 2020Fracture; Fracture

  WHEN GRASPING A VERY THICK-WALLED GALLBLADDER, A ""BRANCH"" OF THE GRASPING FORCEPS BROKE OFF, LANDED BEHIND THE LIVER, WAS LOCALIZED BY X-RAY, AND WAS EASILY REMOVED LAPAROSCOPICALLY. THE REST OF THE OPERATION WAS UNPROBLEMATIC.

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

  MAUDE report 10520242 ↗
• MalfunctionJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE WITH A MICROLINE 3222 FENESTRATED GRASPER, DR. (B)(6) NOTICED THE HEAT SHRINK OF THE DISPOSABLE GRASPER TIP HAD COME OFF OF THE TIP AND WAS FREELY FLOATING AROUND THE ABDOMEN OF THE PATIENT. THE HEAT SHRINK WAS RETRIEVED, AND ALL POSSIBLE BOXES THAT THE TIP COULD OF CAME FROM REMOVED FROM CIRCULATION. LOT NUMBERS IMPACTED: 00147564, 00148767, 00148821.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9560133 ↗
• MalfunctionJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE WITH A MICROLINE 3222 FENESTRATED GRASPER, DR. (B)(6) NOTICED THE HEAT SHRINK OF THE DISPOSABLE GRASPER TIP HAD COME OFF OF THE TIP AND WAS FREELY FLOATING AROUND THE ABDOMEN OF THE PATIENT. THE HEAT SHRINK WAS RETRIEVED, AND ALL POSSIBLE BOXES THAT THE TIP COULD OF CAME FROM REMOVED FROM CIRCULATION. LOT NUMBERS IMPACTED: 00147564, 00148767, 00148821.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9560067 ↗
• MalfunctionJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE WITH A MICROLINE 3222 FENESTRATED GRASPER, DR. (B)(6) NOTICED THE HEAT SHRINK OF THE DISPOSABLE GRASPER TIP HAD COME OFF OF THE TIP AND WAS FREELY FLOATING AROUND THE ABDOMEN OF THE PATIENT. THE HEAT SHRINK WAS RETRIEVED, AND ALL POSSIBLE BOXES THAT THE TIP COULD OF CAME FROM REMOVED FROM CIRCULATION. LOT NUMBERS IMPACTED: 00147564, 00148767, 00148821.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9560048 ↗
• MalfunctionAug 26, 2019Material Fragmentation; Material Fragmentation

  DURING A PROCEDURE IT WAS DISCOVERED THAT THE HEAT SHRINK BROKE AND FELL INTO THE PATIENT'S ABDOMEN. THE PIECES WERE RETRIEVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8931830 ↗
• MalfunctionAug 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE JAW BROKE ON THE FENESTRATED GRASPER DURING A PROCEDURE AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8875205 ↗
• MalfunctionApr 16, 2019Fracture; Fracture

  JAW BROKE. THERE WAS NO HARM TO THE PATIENT AND THE ANESTHESIA TIME WAS NOT EXTENDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8520157 ↗
• MalfunctionApr 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE HEAT SHRINK CAME OFF THE TIP AND FELL INTO THE PATIENT'S ABDOMEN DURING A PROCEDURE. THE PIECE WAS ABLE TO BE RETRIEVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8520154 ↗
• MalfunctionMar 29, 2019Fracture; Fracture

  SURGEON WAS COMPLETING A LIVER RESECTION WHEN ONE SIDE OF THE GRASPER BROKE OFF AND FELL INTO THE ABDOMEN. THE PIECE WAS ABLE TO BE RETRIEVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8463686 ↗
• MalfunctionMar 29, 2019Fracture; Fracture

  THE GRASPER TIP WAS CLOSED ON TISSUE WHEN THE SURGEON FELT A POP AND THE JAW BROKE JUST ABOVE THE YOLK. THE PIECE WAS ABLE TO BE RETRIEVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8463685 ↗
• MalfunctionMar 29, 2019Fracture; Fracture

  GRASPER TIP BROKE OFF INSIDE PATIENT. ENTIRE JAW OF ONE SIDE BROKE OFF. PROCEDURE WAS EXTENDED BY 5 MINUTES. THE PIECE WAS ABLE TO BE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8463681 ↗
• MalfunctionFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE HEAT SHRINK PORTION OF THE DISPOSABLE TIP CAME OFF IN THE ABDOMINAL CAVITY. THE PIECE WAS ABLE TO BE RETRIEVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8363443 ↗
• MalfunctionFeb 22, 2019Material Integrity Problem; Material Integrity Problem

  ONE OF THE JAWS ON THE GRASPERS BROKE OFF DURING A PROCEDURE AND NEEDED TO BE RETRIEVED FROM INSIDE OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363442 ↗
• MalfunctionFeb 8, 2019Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  BLACK COLLAR COMPONENT OF THE DISPOSABLE TIP HAS DETACHED FROM THE TIP AND FALLEN INSIDE THE PATIENT. THE COMPONENT WAS FOUND RECOVERED AND COLLECTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8322178 ↗
• MalfunctionAug 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING A SURGICAL PROCEDURE, THE HEAT SHRINK CAME OFF FROM THE RENEW FENESTRATED GRASPER TIP, BUT DID NOT FALL INTO THE PATIENT. THE MALFUNCTIONED TIP WAS NOT USED IN THE PATIENT AND THE SURGEON USED A NEW TIP. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806356 ↗
• MalfunctionJul 2, 2018Material Fragmentation; Material Fragmentation

  AT THE END OF A HYSTERECTOMY PROCEDURE, THE SURGEON NOTICED THAT A FRAGMENT OF THE HEAT SHRINK INSULATION TUBE FELL INTO THE PATIENT'S PERITONEAL CAVE. THE FRAGMENT WAS ABLE TO BE RETRIEVED. THE PROCEDURE AND ANESTHESIA TIME WERE EXTENDED FOR AN UNKNOWN AMOUNT OF TIME. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7654785 ↗