Polysorb 170056Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 20884521126579), received between Aug 20, 2017 and Jun 25, 2026 — classified as 18 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (26 reports).

2 other recalls cover devices cleared under the same FDA submission (K934738); they may or may not involve this specific model.

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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Break

  IT WAS REPORTED THAT, DURING A HYSTERECTOMY, THE NEEDLES OF NINE SUTURES BROKE OFF. THE DEVICE WAS REPLACED. THERE NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617948 ↗
• MalfunctionJun 25, 2026Break

  IT WAS REPORTED THAT, DURING A HYSTERECTOMY, THE NEEDLES OF NINE SUTURES BROKE OFF. THE DEVICE WAS REPLACED. THERE NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617924 ↗
• MalfunctionJun 25, 2026Break

  IT WAS REPORTED THAT, DURING A HYSTERECTOMY, THE NEEDLES OF NINE SUTURES BROKE OFF. THE DEVICE WAS REPLACED. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617907 ↗
• MalfunctionJun 25, 2026Break

  IT WAS REPORTED THAT, DURING A HYSTERECTOMY, THE NEEDLES OF NINE SUTURES BROKE OFF. THE DEVICE WAS REPLACED. THERE NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617883 ↗
• MalfunctionJun 25, 2026Break

  IT WAS REPORTED THAT, DURING A HYSTERECTOMY, THE NEEDLES OF NINE SUTURES BROKE OFF. THE DEVICE WAS REPLACED. THERE NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617860 ↗
• MalfunctionJun 24, 2026Break

  IT WAS REPORTED THAT, DURING A HYSTERECTOMY, ONE NEEDLE BROKE OFF AND TWICE DURING RELOAD. THE DEVICE WAS REPLACED. THERE NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611715 ↗
• InjuryMay 15, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, AT THE TIME OF CLOSURE OF THE VAGINAL CUFF, THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT CAVITY. THE NEEDLE WAS NOT RETRIEVED. AN X-RAY WAS PERFORMED PRIOR TO REMOVAL OF THE PATIENT FROM THE OPERATING ROOM AND CONFIRMED THAT THE NEEDLE DID NOT APPEAR TO BE NEAR ANY MAJOR VESSELS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE TIME TAKEN TO OBTAIN THE X-RAY.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 25186563 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT, DURING A HYSTERECTOMY, ONE NEEDLE BROKE OFF AND TWICE DURING RELOAD. THE DEVICE WAS REPLACED. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073668 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT, DURING A HYSTERECTOMY, ONE NEEDLE BROKE OFF AND TWICE DURING RELOAD. THE DEVICE WAS REPLACED. THERE NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072787 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT, DURING A HYSTERECTOMY, ONE NEEDLE BROKE OFF AND TWICE DURING RELOAD. THE DEVICE WAS REPLACED. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072775 ↗
• MalfunctionMay 21, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A HYSTERECTOMY PROCEDURE, THE TWO NEEDLE BROKE WHILE USING THE TWO SUTURING HANDLES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059725 ↗
• MalfunctionMay 21, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A HYSTERECTOMY PROCEDURE, THE TWO NEEDLE BROKE WHILE USING THE TWO SUTURING HANDLES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059700 ↗
• InjurySep 11, 2024Break; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Break; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE BROKE. IT WAS NOTED THAT HALF OF THE NEEDLE WAS LEFT IN THE PATIENT CAVITY AND WAS NOT RETRIEVED. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE. PRODUCT WAS RECEIVED WITHOUT ACCOMPANYING INFORMATION.

  Patient problems: Burning Sensation; Distress; Emotional Changes; Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Pain; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 20196246 ↗
• InjurySep 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, HALF OF THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT CAVITY. THE USER SEARCHED FOR THE NEEDLE BUT WAS UNABLE TO FIND THE COMPONENT. IT WAS NOTED AN X-RAY WAS USED TO SEARCH FOR THE DEVICE AND THE NEEDLE WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 20150947 ↗
• InjuryMay 1, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPY GYNECOLOGIC ONCOLOGY PROCEDURE, SUTURING OF THE CERVIX, THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT'S CAVITY AND CANNOT BE RETRIEVED. AN X-RAY WAS PERFORMED AND THE NEEDLE THAT BROKE OFF STILL REMAINS IMPLANTED IN THE CERVIX.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19219461 ↗
• InjurySep 1, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE DEVICE WAS BEING APPLIED TO THE VAGINAL CUFF. HOWEVER, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. THE BROKEN COMPONENT WAS RETRIEVED USING A LAPAROSCOPIC GRASPER. AN X-RAY WAS PERFORMED TO LOCATE THE COMPONENT AND CONFIRM THAT ALL PIECES WERE LOCATED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17671281 ↗
• MalfunctionJul 24, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, THE NEEDLE BROKE AND FELL IN PATIENT CAVITY. THE USER MANAGED TO RETRIEVE PIECES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379527 ↗
• InjuryMay 9, 2023Break; Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC TOTAL/SUBTOTAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, DEBULKING OF FIBROID AND CYSTO SCOPY. WHILE THE DEVICE WAS BEING APPLIED TO THE VAGINAL CUFF THE DEVICE RELOAD BROKE INTO THREE. ONE OF THE BROKEN NEEDLE PORTION REMAINED IN THE HANDLE THE 2ND PART BROKE OFF FELL INTO THE PATIENT AND IT REMAINS IN THE PATIENT AS IT COULD NOT BE FOUND, AND THE 3RD PIECE WHICH IS THE SUTURE THAT DETACHED FROM THE NEEDLE WHICH WAS RETRIEVED. AFTER RETRIEVING THE DETACHED SUTURE AND THE PORTION OF THE NEEDLE THAT REMAINED IN THE HANDLE, THE OPERATIVE TEAM SEARCHED UNSUCCESSFULLY FOR THE REMAINING BROKEN PIECE OF THE NEEDLE. THE OPERATIVE TEAM DECIDED NOT TO USE AND X-RAY AS THE PIECE WOULD BE TOO SMALL TO BE PICKED UP. THE BROKEN PIECE OF THE NEEDLE THAT REMAINED IN THE HANDLE WAS DIFFICULT TO UNLOAD. IT WAS ALSO REPORTED THAT UNNECESSARY TISSUE WAS EXCISED WHILE ATTEMPTING TO FIND THE BROKEN PIECE OF THE NEEDLE THAT REMAINED IN THE PATIENT. THE SURGICAL TEAM EXCISED TISSUE THAT MAY CONTAIN THIS BROKEN PIECE OF THE NEEDLE HOWEVER THE BROKEN PIECE COULD STILL NOT BE FOUND. THE SURGICAL TIME WAS EXTENDED BY TWO HOURS DUE TO THE ISSUE. AN ADDITIONAL TWO R

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 16899038 ↗
• MalfunctionApr 11, 2023Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC MYOMECTOMY, WHILE ON CLOSING OF MYOMETRIUM LAYER. THE TWO NEEDLES BROKE AND ONE NEEDLE BENT. THE NEEDLE FELL INTO THE PATIENT CAVITY AND THE SURGEON BELIEVES IT WAS STILL EMBEDDED IN THE UTERUS. AN X-RAY WAS PERFORMED BUT THE PORTION OF THE NEEDLE COULD NOT BE FOUND AND DETECTED. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 16714834 ↗
• InjuryApr 11, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC MYOMECTOMY, WHILE ON CLOSING OF MYOMETRIUM LAYER, THE TWO NEEDLES BROKE AND ONE NEEDLE BENT. THE NEEDLE FELL INTO THE PATIENT CAVITY AND THE SURGEON BELIEVES IT WAS STILL EMBEDDED IN THE UTERUS. AN X-RAY WAS PERFORMED BUT THE PORTION OF THE NEEDLE COULD NOT BE FOUND AND DETECTED. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 16714802 ↗
• MalfunctionMay 5, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE SUTURING THE CUFF, THE NEEDLE BROKE INTO HALF AND FELL INTO THE PATIENT'S CAVITY. THERE WAS A SURGICAL EXTENSION OF 30 MINUTES OR MORE TO SEARCH FOR THE PORTION OF THE NEEDLE THAT HAD BROKEN OFF AND IT WAS RECOVERED. TO RESOLVE THE ISSUE, THE SURGEON OPENED A NEW SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14289373 ↗
• InjuryOct 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE NEEDLE FELL INTO THE PATIENT¿S CAVITY. AFTER REPEATED ATTEMPTS TO LOCATE THE NEEDLE, THE PROCEDURE WAS CONVERTED TO OPEN. AN X-RAY WAS PERFORMED ON THE SAME DAY FOR THE EXPRESS PURPOSE OF LOCATING THE COMPONENT, OR CONFIRMING THAT ALL PIECES WERE LOCATED. THE NEEDLE WAS RETRIEVED. THE INCISION WAS ALSO EXTENDED. THE PATIENT WAS CLOSED WITH A DEVICE FROM ANOTHER MANUFACTURER. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR GREATER.

  Patient problems: Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 12602177 ↗
• InjuryOct 5, 2020Break; Dull, Blunt; Detachment of Device or Device Component; Break; Dull, Blunt; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE VAGINAL CUFF CLOSURE ON A LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE WAS PASSING THROUGH SOFT TISSUE NEAR THE LEFT UTEROSACRAL LIGAMENT WHEN IT BECAME DIFFICULT TO PASS. THE NEEDLE BROKE, AND HALF OF THE NEEDLE REMAINED IN THE PATIENT. THE SURGEON ATTEMPTED TO REMOVE, BUT ABANDONED ATTEMPT DEEMING IT TOO DANGEROUS TO REMOVE. IT WAS ALSO REPORTED THAT X-RAY WAS PERFORMED. THIS RESULTED TO EXTENDED SURGICAL TIME OF MORE THAN 30 MINUTES. ANOTHER SUTURE RELOAD WAS USED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient; No Code Available; Unintended Radiation Exposure

  MAUDE report 10625791 ↗
• InjuryOct 1, 2020Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC UTERO SACROCOLPOPEXY, WHILE SUTURING INTO LEFT UTEROSACRAL LIGAMENT, THE NEEDLE BECAME STUCK AND THE SUTURE CAME OFF THE NEEDLE. THE NEEDLE THEN CAME OFF THE JAW OF THE HANDLE. THE NEEDLE WAS STUCK IN THE TISSUE AND COULD NOT BE RETRIEVED WITHOUT CAUSING DAMAGE. AN X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE NEEDLE. THE NEEDLE REMAINS EMBEDDED IN TISSUE AS IT WAS TOO DANGEROUS TO REMOVE. THE ATTEMPT TO RETRIEVE THE NEEDLE WAS THEN ABANDONED. THE TECH TRIED TO RELOAD THE HANDLE AFTERWARDS, BUT THE DEVICE FELT ¿CLICKY¿ WHEN LOADED AND TOGGLED. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THE SURGICAL TIME EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Foreign Body In Patient; No Code Available; Unintended Radiation Exposure

  MAUDE report 10613948 ↗
• MalfunctionJan 29, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN CLOSING THE CUFF TOWARDS THE END OF THE PROCEDURE DURING A LAPAROSCOPIC HAND ASSISTED VAGINAL HYSTERECTOMY, THE NEEDLE BROKE WHILE REMOVING THE DEVICE FROM THE PATIENT CAVITY AT THE TROCAR SITE. THE SURGEON CONTINUED AS NORMAL TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641266 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K934738. One submission often covers many models, so check the product and lot details in each record.

• Z-2281-2026 · Apr 15, 2026 · Open, Classified
  Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
• Z-2543-2017 · May 3, 2017 · Terminated
  Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU