Polysorb 170052Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 20884521126746), received between Apr 25, 2017 and Jun 24, 2025 — classified as 26 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 57 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE TOTAL HYSTERECTOMY, THE NEEDLE BROKE DURING USE. HALF OF THE NEEDLE WAS FOUND IMMEDIATELY. AN X-RAY WAS TAKEN TO LOCATE THE SECOND HALF OF THE NEEDLE, WHICH WAS EVENTUALLY REMOVED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22318852 ↗
• InjuryFeb 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE CLOSING THE VAGINAL CUFF THE NEEDLE BROKE. A PART OF THE NEEDLE WAS NOT RETRIEVED AND WAS LEFT IN THE VAGINAL CUFF OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21410792 ↗
• InjuryFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY WHILE CLOSING THE VAGINAL CUFF, A PARTIAL NEEDLE FROM THE DEVICE WAS LEFT IN THE VAGINAL CUFF. THE ISSUE WAS RESOLVED BY LEAVING THE PARTIAL NEEDLE IN PLACE, AND NO ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21410016 ↗
• MalfunctionJan 3, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE. HALF IN THE INSTRUMENT AND THE OTHER HALF WAS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 21073290 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE SUTURE TORE AND BROKE IN HALF WHILE BEING APPLIED TO THE GASTROJEJUNOSTOMY. ONE PIECE WAS STILL CONNECTED TO THE ENDOSTITCH INSTRUMENT, AND THE OTHER WAS STILL IN THE PATIENT. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. THE TORN SUTURE WAS REMOVED, A NEW SUTURE WAS USED WITH THE SAME INSTRUMENT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072968 ↗
• InjuryAug 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, IN CLOSING THE VAGINAL CUFF, WHILE TAKING AN ANTERIOR "PURCHASE/BITE", THE NEEDLE BROKE, WITH A SMALL PORTION REMAINING IN THE PATIENT AS THE SURGEON WAS UNABLE TO LOCATE AND RETRIEVE IT. ANOTHER RELOAD WAS USED, BUT THE SAME ISSUE OCCURRED. HOWEVER, THE SECOND BROKEN NEEDLE WAS ABLE TO BE RETRIEVED. X-RAY WERE NOT PERFORMED. A MANUAL SUTURE WAS USED TO RESOLVE THE ISSUE. THIS LED TO 30 MINUTES EXTENDED SURGICAL TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 19942140 ↗
• InjuryAug 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, IN CLOSING THE VAGINAL CUFF, WHILE TAKING AN ANTERIOR "PURCHASE/BITE", THE NEEDLE BROKE, WITH A SMALL PORTION REMAINING IN THE PATIENT AS THE SURGEON WAS UNABLE TO LOCATE AND RETRIEVE IT. ANOTHER RELOAD WAS USED, BUT THE SAME ISSUE OCCURRED. HOWEVER, THE SECOND BROKEN NEEDLE WAS ABLE TO BE RETRIEVED. X-RAY WERE NOT PERFORMED. A MANUAL SUTURE WAS USED TO RESOLVE THE ISSUE. THIS LED TO 30 MINUTES EXTENDED SURGICAL TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 19941999 ↗
• InjuryJun 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE OVER SEWING THE SLEEVE STAPLE LINE HALF THE WAY DOWN THE SLEEVE, THE NEEDLE BROKE INTO TWO PIECES. THE NEEDLE FELL INTO THE PATIENT¿S CAVITY. AN X-RAY AND ENDOSCOPY WAS PERFORMED. ONE PIECE WAS IMMEDIATELY RETRIEVED, BUT THE OTHER PIECE GOT EMBEDDED IN THE TISSUE AND WAS LEFT BY THE SURGEON AS STAPLING THE PIECE OUT WOULD HAVE INCREASED THE STRICTURE RISK SINCE THE SLEEVE WAS ALREADY NARROW. THE SURGICAL TIME WAS EXTENDED FOR 90 MINUTES DUE TO THE ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19639108 ↗
• InjuryMay 9, 2024Break; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, WHEN SUTURING THE VAGINAL CUFF DURING ONE OF THE PASSES THE NEEDLE WAS NOT PULLED THROUGH BY THE OPPOSING JAW OF THE INSTRUMENT. WHEN THE SUTURE WAS REMOVED FROM THE TISSUE, THE NEEDLE WAS INCOMPLETE. THE SURGICAL TEAM SEARCHED FOR THE NEEDLE FRAGMENT LAPAROSCOPICALLY WITHOUT SUCCESS. AN X-RAY WAS TAKEN WHICH CONFIRMED THAT AN ESTIMATED 4MM LONG PIECE OF THE NEEDLE REMAINED IN THE PATIENT'S TISSUE. THE SURGEON PERFORMED A RISK ASSESSMENT AND DETERMINED THAT THE BEST PLAN OF CARE WAS TO LEAVE THE PIECE OF NEEDLE WHERE IT WAS. THE PROCEDURE WAS COMPLETED USING A NEW RELOAD FROM THE SAME LOT, ON THE SAME HANDLE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19281654 ↗
• MalfunctionJan 19, 2024Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL PROLAPSE REPAIR PROCEDURE, THERE WAS DIFFICULTY IN GETTING THE NEEDLE TO RELEASE. THE NEEDLE BROKE AS IT GOT OUT OF THE HANDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18546007 ↗
• MalfunctionJan 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, UPON CLOSURE OF THE COLPOTOMY, THE NEEDLE BROKE OFF, BUT IT WAS RETRIEVED AND REMOVED. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18481112 ↗
• InjuryDec 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, UPON CLOSING OFF THE VAGINAL CUFF, PART OF THE NEEDLE BROKE OFF INTO THE CUFF AND WAS SUCCESSFULLY RETRIEVED AFTER AN X-RAY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18406835 ↗
• InjurySep 28, 2023Break; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC BYPASS PROCEDURE, WHEN PASSING THROUGH THE TISSUE, THE DEVICE WAS DIFFICULT TO TOGGLE AND THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, WHICH WAS ABLE TO BE RETRIEVED. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17836038 ↗
• MalfunctionJul 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE SUTURE WAS BEING USED WHEN THE NEEDLE DISLODGED OFF THE DEVICE WITHOUT BEING PROMPTED LEAVING IT RETAINED IN THE PATIENT TISSUE. THE SURGEON WAS ABLE TO GET OUT THE NEEDLES. THE DEVICE AND NEEDLE WERE TAKEN OUT OF USE AND A NEW INSTRUMENT WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330429 ↗
• MalfunctionJul 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE SUTURE WAS BEING USED WHEN THE NEEDLE DISLODGED OFF THE DEVICE WITHOUT BEING PROMPTED LEAVING IT RETAINED IN THE PATIENT TISSUE. THE SURGEON WAS ABLE TO GET OUT THE NEEDLES. THE DEVICE AND NEEDLE WERE TAKEN OUT OF USE AND A NEW INSTRUMENT WAS USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330428 ↗
• InjuryJan 23, 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 A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, AT THE FINAL STEPS OF CLOSING THE PERITONEUM, THE JAWS OF THE DEVICE WERE CLOSED AND THE SURGEON FELT A CLUNK. WHEN THE SURGEON WITHDREW THE DEVICE, THE NEEDLE WAS BROKEN. THE BROKEN PORTION OF THE NEEDLE FELL INTO THE PATIENT'S CAVITY AND AN X-RAY WAS PERFORMED, BUT THE REMAINING PORTION OF THE NEEDLE WAS NOT FOUND. THE SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16229992 ↗
• MalfunctionOct 7, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE COLPOTOMY, THE NEEDLE BROKE IN HALF AND FELL INTO THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO VISUALIZED AND RETRIEVED THE HALF OF THE NEEDLE AND USED A NEW RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567993 ↗
• InjurySep 15, 2022Break; 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 A LAPAROSCOPIC PROCEDURE, THE NEEDLE BROKE INSIDE THE PATIENT. AN X RAY WAS REQUIRED TO LOCATE THE NEEDLE, AND IT WAS REMOVED BY A SURGEON. THE REMOVAL CONFIRMED VIA A SECOND X RAY.

  Patient problems: Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 15429159 ↗
• MalfunctionMay 7, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE BROKE INTO TWO PIECES IN THE PATIENT AND WERE RETRIEVED. A NEW DEVICE AND SUTURE WERE OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319778 ↗
• InjuryOct 1, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, IT WAS DISCOVERED THAT THE NEEDLE WAS BROKEN INTO TWO PIECES. ONE FELL OFF THE DEVICE WHEN IT WAS REMOVED BUT WAS FOUND ON THE FLOOR. THE OTHER PIECE WAS THOUGHT TO HAVE BEEN RETAINED INSIDE THE PATIENT. THE SURGEON AND FELLOW HELPED SEARCHING BUT WERE UNABLE TO FIND THE SECOND BROKEN PIECE. THE PORTABLE X-RAY DID NOT DETECT THE SECOND PIECE. THE MISSING PART WAS ESTIMATED TO BE APPROXIMATELY 4.5MM, SO VERY SMALL. UNLIKELY TO REQUIRE SURGICAL REMOVAL EVEN IF IT WAS RETAINED AND COULD BE FOUND.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 12561045 ↗
• InjurySep 7, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING RIGHT VIDEO ASSISTED SURGERY, EVACUATION OF HEMOTHORAX, DECORTICATION, CHEST WALL RECONSTRUCTION, TIP PORTION OF SUTURE NEEDLE BROKE OFF AND RETAINED IN PATIENT. SURGEON ATTEMPTED RETRIEVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 12431597 ↗
• InjuryJul 28, 2021Mechanical Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, AT APPROXIMATELY THE 4TH PASS OF THE SUTURE IN THE IMBRICATION TOWARDS THE TOP OF THE SLEEVE AT THE FUNDUS, THE PATIENT'S STOMACH DISPLAYED A SIZEABLE HEMATOMA CAUSED BY SUTURE STICKING. THE PATIENT ALSO EXPERIENCED TISSUE DAMAGE AND BLEED MORE THAN NORMAL. TO RESOLVE THE ISSUE A NEW HANDLE AND RELOAD WERE OPENED AND USED TO COMPLETE THE CASE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12240618 ↗
• MalfunctionApr 12, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL ABDOMINAL LAPAROSCOPIC HYSTERECTOMY, THE TIP OF THE NEEDLE BROKE OFF INTO THE PATIENT'S CAVITY AND WAS RETRIEVED USING FORCEPS. THE HANDLE WAS REPLACED ALONG WITH THE RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 11648737 ↗
• MalfunctionApr 12, 2021Break; Detachment of Device or Device Component; Insufficient Device Problem Information; Break; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A TOTAL ABDOMINAL LAPAROSCOPIC HYSTERECTOMY, THE TIP OF THE NEEDLE BROKE OFF INTO THE PATIENT'S CAVITY AND WAS RETRIEVED USING FORCEPS. THE HANDLE WAS REPLACED ALONG WITH THE RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648711 ↗
• InjurySep 14, 2020Use of Device Problem; Dull, Blunt; Human-Device Interface Problem; Use of Device Problem; Dull, Blunt; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN THE DEVICE WAS BEING APPLIED AT IMBERCATION OF THE STAPLE LINE AFTER STAPLE FIRING <(>&<)> RESECTION OF THE GREATER CURVATURE OF THE STOMACH, FROM THE FIRST PASS OF THE NEEDLE RELOADS AT THE TOP OF THE STOMACH, AN AUDIBLE CRUNCH COULD BE HEARD. AFTER FEW PASSES, THE SUTURES BECAME HUNG UP WITHIN THE TISSUE. THE SURGEON TWISTED, SQUEEZED AND PULLED THE DEVICE TO FREE IT FROM THE TISSUE AND AS THE NEEDLE FINALLY PASSED THROUGH, THERE WAS ADDITIONAL BLEEDING FROM THE STOMACH TISSUE. THE SURGEON REQUESTED FOR SURGICAL SNOW TO APPLY TO THE BLEEDING. THE NEEDLES WERE BLUNT AND THERE WERE ALSO DIFFICULTY PASSING THE NEEDLE INTO THE RECEIVING SOCKET/HOLE. TISSUE DAMAGE WAS NOTED. THE SURGEON CONTINUED TO USE THE DEVICE TO COMPLETE IMBERCATING THE REST OF THE STAPLE LINE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10530923 ↗

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