CapioRecalls & reported problems across all models

We found 2 models of Capio by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 91 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2016 and Aug 31, 2026 — classified as 32 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (48 reports).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Capio recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 12, 2018Class IITerminated

   Potential for Capio sutures to break and /or detach.

   Z-1620-2018 · Root cause: Device Design · Recall details · FDA record ↗

2. Feb 12, 2018Class IITerminated

   Potential for Capio sutures to break and /or detach.

   Z-1619-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Capio problems

Capio models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Capio M0068311250

  HOLDER, NEEDLE, GASTROENTEROLOGIC
  1 recall77 reports
• Capio M0068312320

  Laparoscope, general & plastic surgery
  1 recall14 reports

Recent Capio adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Detachment of Device or Device Component

  It was reported to Boston Scientific Corporation that, during the use of a Capio device, the bullet needle detached from the suture when the device was removed from the cavity during the first pass through the ligament. An attempt was made to recover the needle, but it could not be found because it was too small to locate. The procedure was completed using the original Capio device. There were no patient complications reported.

  Patient problems: Foreign Body In Patient

  MAUDE report 50515512 ↗
• MalfunctionMay 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO DEVICE, THE BULLET DETACHED FROM THE SUTURE ON TWO SEPARATE MONODEK SUTURES. INITIALLY, THE BULLET WAS THOUGHT TO BE LODGED IN THE PELVIS; HOWEVER, IT WAS LATER DETERMINED TO BE RETAINED WITHIN THE CHANNEL ON THE CAPTURE SIDE OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128181 ↗
• MalfunctionMar 2, 2026Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED USING A CAPIO SLIM DEVICE, THE DEVICE MISFIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483077 ↗
• MalfunctionJan 14, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION, WHEN THE TECHNICIAN OPENED THE CAPIO DEVICE, IT WAS DISCOVERED THAT IT WAS NOT SEALED. THE CAPIO DEVICE SLIPPED FROM THE PACKAGING, FELL TO THE FLOOR, AND BECAME UNUSABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO SLIM AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073127 ↗
• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BULLET WAS NOT SEATED IN THE DEVICE AFTER DEPLOYMENT. THE BULLET CANNOT BE LOCATED UPON INSPECTION AND IS SUSPECTED TO BE LODGED WITHIN THE DEVICE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645577 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CAPIO SUTURING DEVICE FIRED CORRECTLY BUT THE BULLET COULD NOT BE RETRIEVED FROM THE DEVICE. A SEARCH WAS CONDUCTED AS PART OF THE TROUBLESHOOTING PROCESS, AND THE BULLET MAY HAVE LODGED WITHIN THE DEVICE; HOWEVER, THE BULLET COULD NOT BE LOCATED. THE PROCEDURE WAS COMPLETED USING A SECOND DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451599 ↗
• MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO DEVICE, THE DART DETACHED FROM THE SUTURE. ANOTHER CAPIO SLIM DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401504 ↗
• MalfunctionApr 4, 2025Misfire; Detachment of Device or Device Component; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE USING A CAPIO DEVICE, THE DEVICE MISFIRED WHILE ATTEMPTING TO PLACE THE SUTURE IN THE LIGAMENT. AN ATTEMPT WAS MADE TO RETRIEVE THE SUTURE, BUT THE DART DETACHED FROM THE SUTURE. GIVEN THE SIZE OF THE SUTURE, THE PHYSICIAN DECIDED TO RETAIN THE SUTURE DART WITHIN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21773166 ↗
• MalfunctionOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PROCEDURE USING A CAPIO DEVICE, THE DART DETACHED. THE DART FELL INSIDE THE PATIENT AND THE PHYSICIAN STATED THAT IT WOULD HAVE MORE RISK IF THE DETACHED DART WOULD NOT BE RETRIEVED AND REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20558981 ↗
• MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO SLIM DEVICE, THE DART DETACHED AND FELL OFF INSIDE THE PATIENT. AN X-RAY WAS PERFORMED TO SEE WHERE THE BULLET WENT; HOWEVER, IT WAS NOT LOCATED AND THE PHYSICIAN DECIDED TO LEAVE IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20467317 ↗
• MalfunctionOct 10, 2024Use of Device Problem; Detachment of Device or Device Component; Difficult to Open or Close; Use of Device Problem; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RETROPUBIC MID-URETHRAL SLING PROCEDURE. DURING THE SAME SURGERY, SACROSPINOUS HYESTEROPEXY, ANTERIOR COLPORRHAPHY, AND POSTERIOR COLPORRHAPHY PROCEDURES WERE ALSO PERFORMED. IT WAS NOTED THAT THE BULLET BROKE OFF THE SUTURE AND GOT STUCK INTO THE METAL INSIDE THE DEVICE. ----ADDITIONAL INFORMATION RECEIVED ON OCTOBER 22, 2024. IT WAS LATER CLARIFIED THAT THE BULLET DID NOT BREAK OFF THE SUTURE. DURING THE PROCEDURE, THE SUTURE WAS NOT CATCHING THE LIGAMENT, AND THE DART WAS NOT CAUGHT IN THE CAGE. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS REPORTING CRITERIA FOR THE DEVICE IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20419082 ↗
• MalfunctionSep 19, 2024

  UPON FIRING BULLET AND AFTER PULLING SUTURE BACK, THE BULLET BROKE OFF OF SUTURE AND STUCK INTO METAL INSIDE OF DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 20256677 ↗
• MalfunctionJul 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A VAULT SUSPENSION PROCEDURE USING A CAPIO SUTURING DEVICE, THE CAPIO CARRIER EXTENDED WHEN THE DEVICE WAS ACTUATED; HOWEVER, THE DART WAS LEFT IN THE TISSUE OF THE PATIENT. THIS WAS EVENTUALLY VIEWED ON AN X-RAY. A NON-BOSTON SCIENTIFIC SUTURE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19784257 ↗
• MalfunctionJul 4, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE, THE DEVICE WOULD NOT CAPTURE THE SUTURE AND THE SUTURE BROKE WHERE IT CONNECTS TO THE DART. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO SLIM DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19675022 ↗
• MalfunctionJul 3, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING TWO CAPIO DEVICES, IT WOULD NOT CAPTURE THE SUTURE AND THE HEADS BROKE OFF THE SUTURE LINE. THERE WAS NO INFORMATION ON WHAT COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2024-38799 FOR THE FIRST CAPIO DEVICE, AND 2124215-2024-38800 FOR THE SECOND CAPIO DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669333 ↗

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