V-Loc 90 VLOCM0614Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521132603), received between Oct 2, 2018 and Jun 12, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K100257); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Break

  IT WAS REPORTED THAT DURING A TONSILLECTOMY, THE NEEDLE BROKE AND A BROKEN NEEDLE FRAGMENT WAS RETAINED IN THE SOFT TISSUE OF THE ORAL THROAT AREA. C ARM FLUOROSCOPY WAS REQUIRED TO LOCATE THE FRAGMENT, AND IT WAS LOCATED BUT NOT RETRIEVABLE AT THE TIME. THE PROCEDURE TIME WAS EXTENDED BY APPROXIMATELY 5 HOURS. EXTENDED HOSPITALIZATION WAS REPORTED. ADDITIONAL SURGERY WAS PLANNED APPROXIMATELY 1 WEEK LATER AT ANOTHER CENTER TO RETRIEVE THE RETAINED NEEDLE FRAGMENT.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 25481758 ↗
• MalfunctionOct 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, UPON OPENING THE PACKAGING, IT WAS FOUND THAT THE NEEDLE WAS DETACHED FOR BOTH DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952440 ↗
• MalfunctionOct 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, UPON OPENING THE PACKAGING IT WAS FOUND THAT THE NEEDLE WAS DETACHED FOR BOTH DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949652 ↗
• MalfunctionAug 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, UPON OPENING THE PACKAGE, THE NEEDLE SEPARATED FROM THE SUTURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17474796 ↗
• MalfunctionJul 20, 2023Component Missing; Component Missing

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC RIGHT HEMICOLECTOMY, DURING CLOSURE, WHEN THE SUTURE PACKAGING WAS OPENED, THE SUTURE DID NOT HAVE A NEEDLE ATTACHED. THE SUTURE WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17357787 ↗
• MalfunctionJun 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE STERILE PACKAGE WAS OPENED IT WAS FOUND THAT THE NEEDLE AND THREAD WERE SEPARATED AND COULD NOT BE USED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17146309 ↗
• MalfunctionMay 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE STERILE BAG WAS OPENED AND FOUND THAT THE NEEDLE AND THREAD WERE DETACHED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 16916451 ↗
• MalfunctionApr 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN UNPACKING, IT WAS FOUND THAT THE NEEDLE AND SUTURE WERE DETACHED. TO RESOLVE THE ISSUE, REOPENED A NEW PACK OF SUTURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16836450 ↗
• MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PARTIAL NEPHRECTOMY PROCEDURE, WHEN OPENING THE TWO PACKAGES, THE NEEDLE AND SUTURE WERE FOUND TO BE DETACHED AND NOT APPLIED TO THE BODY. THE SURGEON RE-OPENED A PACK OF SUTURES OF THE SAME MODEL TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15738925 ↗
• MalfunctionAug 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL PACEMAKER IMPLANTATION SURGERY, BEFORE USING ON THE PATIENT, THE THREAD AND NEEDLE WERE FOUND TO BE DISCONNECTED 30 MINUTES WHEN THE PACKAGE WAS OPENED. A NEW SUTURE FROM THE SAME BATCH WAS USED WITHOUT AN ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307536 ↗
• MalfunctionMay 10, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD WAS BROKEN.

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

  MAUDE report 14347701 ↗
• MalfunctionAug 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ELECTROPHYSIOLOGY PROCEDURE OR PACEMAKER IMPLANTATION, THE NEEDLE DETACHED FROM THE THREAD (LIKE A POP-OFF NEEDLE) AFTER 2-3 PASSES THROUGH TISSUE WHILE USING A RUNNING STITCH DURING THE FINAL CLOSURE OF THE SKIN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12287574 ↗
• MalfunctionJul 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN PACEMAKER IMPLANT PROCEDURE, THE NEEDLE SEPARATED FROM THE THREAD WHILE USING RUNNING STITCH ON THE FINAL CLOSURE OF THE SKIN. TO RESOLVE THE ISSUE, THE SURGEON FINISHED THE CLOSURE WITH 3 KNOTS USING VICRYL SUTURE AND COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12223113 ↗
• MalfunctionJul 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN FINAL SKIN CLOSURE ON A OPEN PACEMAKER IMPLANT, THE NEEDLE BECAME DETACHED FROM THE THREAD AFTER TWO TO THREE PASSES THROUGH TISSUE WHILE USING A NORMAL RUNNING STITCH TECHNIQUE. TO RESOLVE THE ISSUE, THE SURGEON USED THREE KNOTS OF ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12223112 ↗
• MalfunctionJul 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN PACEMAKER IMPLANT PROCEDURE, ON THE FINAL CLOSURE OF THE SKIN, THE NEEDLE SEPARATED FROM THE THREAD AFTER FIVE TO SIX PASSES THRU THE TISSUE WHILE USING RUNNING STITCH TECHNIQUE. TO RESOLVE THE ISSUE, A VICRYL SUTURE WAS USED BY THE SURGEON TO FINISHED THE CLOSURE AND COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12223110 ↗
• MalfunctionJul 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON FINAL CLOSURE OF THE SKIN IN A OPEN PACEMAKER IMPLANT, BOTH NEEDLE AND THREAD BROKE WHILE USING RUNNING STITCH TECHNIQUE. TO RESOLVE THE ISSUE, THE SURGEON USED A VICRYL KNOTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12223108 ↗
• MalfunctionJul 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE PACKAGE WAS OPENED AND AN ATTEMPT WAS MADE TO HOLD AND TAKE THE NEEDLE OUT WITH THE NEEDLE HOLDER, THE NEEDLE CAME OFF FROM THE THREAD. IT WAS STATED THAT HANDLING WAS AS USUAL AND THERE WAS NOT ANY PARTICULARLY STRONG TRACTION. AN ADDITIONAL SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163447 ↗
• MalfunctionOct 5, 2020Break; Device Slipped; Break; Device Slipped

  ACCORDING TO THE REPORTER, DURING A CARDIAC DEVICE IMPLANT, WHILE THE SURGEON WAS PERFORMING A BARBED TECHNIQUE FOR THE FIRST PASS THROUGH LOOP END, THE THREAD BROKE AND THE SURGEON NOTICED THAT THE LOOP END CAME UNDONE WHILE PASSING NEEDLE THROUGH THE LOOP. THE LOOP RELEASED, AND WAS UNABLE TO ANCHOR PROPERLY IN TISSUE. A NEW SUTURE PACKAGE WAS OPENED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10625956 ↗
• MalfunctionDec 10, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSURE OF SUBCUTANEOUS TISSUE IN A TOTAL HIP REPLACEMENT PROCEDURE, TWO DIFFERENT SUTURE STRANDS BROKE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9443866 ↗
• MalfunctionOct 15, 2019Break; Break

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, WHILE ATTEMPTING TO SEW THE MESH, BOTH THE NEEDLE AND THE THREAD BROKE. A COMPETITOR'S DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194903 ↗
• MalfunctionDec 18, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROMONTOFIXATION, AT THE END OF THE PROCEDURE, THE THREAD OF THE SUTURE BROKE. THEY USED ANOTHER STRAND TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174636 ↗
• MalfunctionNov 28, 2018Break; Break

  ACCORDING TO THE REPORTER, ON CLOSURE OF LAPAROSCOPIC PROMONTOFIXATION, THE THREAD BROKE WHEN THE SURGEON APPLIED TENSION WITH ITS GRASPERS DURING A PROMONTOFIXATION ON 2 OCCASIONS WITH 2 DIFFERENT SURGEONS. USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8110089 ↗
• MalfunctionOct 2, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ROBOTIC ASSISTED LAPAROSCOPIC HERNIA REPAIR, THE NEEDLE OF THE SUTURE BROKE. THEY RETRIEVED THE NEEDLE WITH GRASPERS. THEY USED ANOTHER PACKAGE OF A SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7926284 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100257. One submission often covers many models, so check the product and lot details in each record.

• Z-2918-2026 · Jun 24, 2026 · Open, Classified
  V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VL