Polysorb SL-5690Recalls & reported problems
Covidien LP · Braided Absorbable Suture · Class 2 · Implant
Quick summary
This Polysorb SL-5690 is a braided absorbable surgical suture made by Covidien. The 28 reports mostly describe the thread snapping or the needle coming loose from the thread during surgery, often when closing the skin at the end of a laparoscopic hernia repair. There are 2 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10884521048799), received between Jan 11, 2018 and Dec 10, 2024 — classified as 2 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Break” (15 reports).
2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); 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.
Reports received per month
Most reported problems
Device problems
- Break15
- Detachment of Device or Device Component15
- Adverse Event Without Identified Device or Use Problem1
- Mechanical Problem1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Known Impact Or Consequence To Patient5
- Insufficient Information4
- No Consequences Or Impact To Patient4
- No Code Available1
- No Patient Involvement1
- Post Operative Wound Infection1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20896461 ↗MalfunctionOct 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR, AT THE END OF THE SURGERY, DURING DERMAL SUTURING OF THE TROCAR WOUND , THE THREE NEEDLE AND THREAD CONTINUED TO BREAK. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17959493 ↗MalfunctionOct 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR, AT THE END OF THE SURGERY, DURING DERMAL SUTURING OF THE TROCAR WOUND , THE THREE NEEDLE AND THREAD CONTINUED TO BREAK. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17959326 ↗MalfunctionOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR, AT THE END OF THE SURGERY, DURING DERMAL SUTURING OF THE TROCAR WOUND , THE THREE NEEDLE AND THREAD CONTINUED TO BREAK. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17943803 ↗MalfunctionOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC REPAIR OF AN INGUINAL HERNIA, ISSUES OCCURRED WHERE THE NEEDLE AND THREAD KEPT UNEXPECTEDLY BECAME DETACHED WHILE IN USE. THIS PROBLEM OCCURRED AT THE END OF THE SURGERY, SPECIFICALLY DURING THE DERMAL SUTURING OF THE TROCAR WOUND. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17942193 ↗MalfunctionOct 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC REPAIR OF AN INGUINAL HERNIA, ISSUES OCCURRED WHERE THE NEEDLE AND THREAD KEPT UNEXPECTEDLY BECAME DETACHED WHILE IN USE. THIS PROBLEM OCCURRED AT THE END OF THE SURGERY, SPECIFICALLY DURING THE DERMAL SUTURING OF THE TROCAR WOUND. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17934742 ↗MalfunctionJul 14, 2022Break; Break
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, THE NEEDLE BROKE. THE PRODUCT WAS REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15013906 ↗MalfunctionMay 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER PASSING THROUGH THE TISSUE SEVERAL TIME, THE NEEDLE DETACHED FROM THE SWAGE. AN ADDITIONAL SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14549308 ↗InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, FOLLOWING AN OPEN UMBILICAL HERNIA REPAIR PROCEDURE, THE PATIENT CAME BACK WITH REDNESS AND INFECTION ON THE WOUND. THE ONLY VARIABLE THEY HAVE BEEN ABLE TO ISOLATE WAS THE SUTURE THAT WAS USED ON THE PATIENT. THE WOUND WAS CLEANED, AND ANTIBIOTICS WERE ADMINISTERED TO COMPLETE THE CASE AND RESOLVE ISSUE.
Patient problems: Post Operative Wound Infection
MAUDE report 14105231 ↗MalfunctionOct 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC SURGERY, BEFORE USE, THE NEEDLE DETACHED FROM THE THREAD. ANOTHER SUTURE FROM ANOTHER LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12653173 ↗MalfunctionJul 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, NEEDLES ARE COMING OUT OF 12 SUTURES.
Patient problems: Insufficient Information
MAUDE report 12119329 ↗MalfunctionJun 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLE IMMEDIATELY CAME OFF THE THREAD BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12014170 ↗MalfunctionMar 17, 2021Break; Break
ACCORDING TO THE REPORTER, THE SUTURE BROKE DURING A PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 11507385 ↗MalfunctionMar 3, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING OPEN SURGERY, THE NEEDLE BROKE INTO TWO. THE NEEDLE ALSO DETACHED FROM THE THREAD.
Patient problems: Insufficient Information
MAUDE report 11405688 ↗MalfunctionJan 14, 2021Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11171080 ↗MalfunctionDec 28, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, UPON SUTURING, SUTURES WERE BREAKING OFF FROM THE NEEDLE AND BREAKING WHILE TRYING TO TIE THEM IN A KNOT. SEVERAL SUTURE WAS TRIED FROM THE SAME BOX AND SAME ISSUE WAS HAPPENING. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11077530 ↗MalfunctionDec 28, 2020Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, UPON SUTURING, SUTURES WERE BREAKING OFF FROM THE NEEDLE AND BREAKING WHILE TRYING TO TIE THEM IN A KNOT. SEVERAL SUTURE WAS TRIED FROM THE SAME BOX AND SAME ISSUE WAS HAPPENING. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11077496 ↗InjuryNov 3, 2020Break; Unraveled Material; Break; Unraveled Material
ACCORDING TO THE REPORTER, ONE HOUR POST-OPERATIVELY ON AN OPEN LIP BIOPSY PROCEDURE, THE DEVICE THREAD BROKE. TO RESOLVE THE ISSUE THE SURGEON HAD TO RE-CLOSED THE INCISION.
Patient problems: No Code Available
MAUDE report 10778992 ↗MalfunctionSep 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE ON AN OPEN PROCEDURE, WHILE EMPLOYING THE CONTINUOUS SUBCUTANEOUS SUTURING TECHNIQUE, THE NEEDLE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10512989 ↗MalfunctionJun 4, 2020Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE SUTURE WAS BEING USED FOR PATIENT, THE NEEDLE BROKE ON THE FIRST POINT. SURGEON REPLACED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10119395 ↗MalfunctionJan 8, 2020Break; Break
ACCORDING TO THE REPORTER, DURING WOUND CLOSURE, WHILE PERFORMING SUBCUTANEOUS STITCH, ALL THE REPORTED DEVICES WERE SAID TO BE BROKEN. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9564725 ↗MalfunctionApr 18, 2019Break; Break
ACCORDING TO THE REPORTER, DURING WOUND CLOSURE IN AN OPEN PROCEDURE, THE THREAD BROKE. THE NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8527023 ↗MalfunctionJan 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE AND SUTURE WERE SEPARATED WHEN REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8289616 ↗MalfunctionJan 18, 2019Break; Break
ACCORDING TO THE REPORTER, DURING WOUND CLOSURE USING SUBCUTICULAR STITCH TECHNIQUE, THE SUTURE THREAD BROKE. NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8260489 ↗MalfunctionJan 4, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8216958 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.
- Z-2601-2018 · Jun 15, 2018 · TerminatedPolysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
- Z-2541-2017 · May 3, 2017 · TerminatedSutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
- Coated VICRYL VCP433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.