Saffron 520350Recalls & reported problems
Coloplast A/S · Anchor · Class 2 · Implant
All models of Saffron (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05708932757690), received between Dec 26, 2023 and May 8, 2026 — classified as 5 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated11
- Material Deformation2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Prolapse4
- Neuralgia1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2026Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN REPORTS THAT THEY DO NOT LIKE HOW THE SAFFRON ANCHORS INTO THE LIGAMENT INSTEAD OF BEING ABLE TO WRAP AROUND THE LIGAMENT WITH THE NON-COLOPLAST DEVICE CAPIO. REPORTEDLY, FROM A SURGEONS STANDPOINT IT¿S MUCH EASIER TO CONFIRM AND FEEL CONFIDENT THAT THEY'RE GOING TO HAVE A GOOD HOLD ON THE LIGAMENT [WITH THE CAPIO]. THE PHYSICIAN HAS HAD SEVERAL SAFFRON ANCHORS FAIL, AND ENDED UP WITH A SACROCOLPOPEXY. PHYSICIAN HAS NOT HAD ANY FAILURES WITH THE CAPIO.
Patient problems: Prolapse
MAUDE report 25124312 ↗InjuryMay 8, 2026Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN REPORTS THAT THEY DO NOT LIKE HOW THE SAFFRON ANCHORS INTO THE LIGAMENT INSTEAD OF BEING ABLE TO WRAP AROUND THE LIGAMENT WITH THE NON-COLOPLAST DEVICE CAPIO. REPORTEDLY, FROM A SURGEONS STANDPOINT IT¿S MUCH EASIER TO CONFIRM AND FEEL CONFIDENT THAT THEY'RE GOING TO HAVE A GOOD HOLD ON THE LIGAMENT [WITH THE CAPIO]. THE PHYSICIAN HAS HAD SEVERAL SAFFRON ANCHORS FAIL, AND ENDED UP WITH A SACROCOLPOPEXY. PHYSICIAN HAS NOT HAD ANY FAILURES WITH THE CAPIO.
Patient problems: Prolapse
MAUDE report 25123924 ↗MalfunctionApr 6, 2026Improper or Incorrect Procedure or Method
ACCORDING TO THE AVAILABLE INFORMATION, AN EXPIRED SAFFRON ANCHOR WAS IMPLANTED IN THE PATIENT. THERE IS NO REPORTED ADVERSE EVENT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793551 ↗MalfunctionDec 6, 2024Break; Break
ACCORDING TO THE AVAILABLE INFORMATION, THE ANCHOR BROKE OFF WHILE BEING LOADED INTO THE SAFFRON DEVICE. THE DOCTOR LOADED THE SUTURE THROUGH THE ANCHOR EYELET AND SECURED THE ENDS OF THE SUTURE WITH A SNAP. IN TRYING TO LOAD THE ANCHOR INTO THE END OF THE SAFFRON FIXATION TOOL - THE DOCTOR POSITIONED THE ANCHOR ABOUT HALF-WAY INTO THE DEVICE, AND THE ANCHOR PORTION SNAPPED OFF OF THE LOADING TAB. THE DOCTOR HAD ANOTHER ANCHOR OPENED AND SUCCESSFULLY LOADED IT INTO THE SAFFRON FIXATION TOOL. NO OTHER ISSUES WERE OBSERVED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20867190 ↗MalfunctionDec 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION, THE SAFFRON ANCHOR PULLED OUT. NO INTERVENTION WAS REQUIRED, AND THE DEVICE WAS EVENTUALLY ANCHORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863980 ↗MalfunctionOct 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION, UPON INSERTING AND DEPLOYING THE FIRST SAFFRON ANCHOR, THE DOCTOR TESTED THE PLACEMENT OF IT AND IT SEEMED SECURE. A SECOND ANCHOR WAS LOADED INTO THE SAFFRON DEVICE, WHEN THE DOCTOR WENT TO PLACE IT , IT WOULD NOT DEPLOY FROM THE SAFFRON TOOL. IT SEEMED STUCK IN THE DEVICE AND PULLED OUT WHEN THE SAFFRON TOOL WAS REMOVED FROM THE PATIENT'S LEFT SIDE. AT THAT SAME TIME, THE DOCTOR CHECKED THE FIRST ANCHOR PLACED ON THE PATIENT'S RIGHT SIDE, AND IT CAME LOOSE. THERE WAS A SMALL AMOUNT OF TISSUE IN THE ANCHOR THAT PULLED OUT. A NEW SAFFRON TOOL WAS ULTIMATELY USED, AND THE SUTURE WAS SWITCHED FROM A ZERO PDS [POLYDIOXANONE] TO A 2.0 PDS TO SUCCESSFULLY PLACE AN ANCHOR INTO THE RIGHT AND LEFT SACROSPINOUS LIGAMENTS. THE REST OF THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427222 ↗MalfunctionOct 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION, UPON INSERTING AND DEPLOYING THE FIRST SAFFRON ANCHOR, THE DOCTOR TESTED THE PLACEMENT OF IT AND IT SEEMED SECURE. A SECOND ANCHOR WAS LOADED INTO THE SAFFRON DEVICE, WHEN THE DOCTOR WENT TO PLACE IT, IT WOULD NOT DEPLOY FROM THE SAFFRON TOOL. IT SEEMED STUCK IN THE DEVICE AND PULLED OUT WHEN THE SAFFRON TOOL WAS REMOVED FROM THE PATIENT'S LEFT SIDE. AT THAT SAME TIME, THE DOCTOR CHECKED THE FIRST ANCHOR PLACED ON THE PATIENT'S RIGHT SIDE, AND IT CAME LOOSE. THERE WAS A SMALL AMOUNT OF TISSUE IN THE ANCHOR THAT PULLED OUT. A NEW SAFFRON TOOL WAS ULTIMATELY USED, AND THE SUTURE WAS SWITCHED FROM A ZERO PDS [POLYDIOXANONE] TO A 2.0 PDS TO SUCCESSFULLY PLACE AN ANCHOR INTO THE RIGHT AND LEFT SACROSPINOUS LIGAMENTS. THE REST OF THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427107 ↗InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT IS SUFFERING NERVE PAIN AFTER A PROLAPSE REPAIR WITH THE SAFFRON LIGAMENT FIXATION DEVICE.
Patient problems: Neuralgia
MAUDE report 19968174 ↗MalfunctionMay 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION, THE SAFFRON ANCHORS PULLED OUT ON BOTH SIDES WHEN ATTEMPTING TO TIE DOWN THE SUTURES. IT WAS FELT THAT THE ANCHORS WERE PROPERLY DEPLOYED AND IMPLANTED IN THE SSL [SACROSPINOUS LIGAMENT]. IT WAS NOTED THAT ONE OF THE ANCHORS HAD DEFORMED BARBS. THE ANCHORS WERE REPLACED WITH SUTURES. THE PATIENT WAS REPORTEDLY DOING WELL POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19221450 ↗MalfunctionMay 1, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
ACCORDING TO THE AVAILABLE INFORMATION, THE SAFFRON ANCHORS PULLED OUT ON BOTH SIDES WHEN ATTEMPTING TO TIE DOWN THE SUTURES. IT WAS FELT THAT THE ANCHORS WERE PROPERLY DEPLOYED AND IMPLANTED IN THE SSL [SACROSPINOUS LIGAMENT]. IT WAS NOTED THAT ONE OF THE ANCHORS HAD DEFORMED BARBS. THE ANCHORS WERE REPLACED WITH SUTURES. THE PATIENT WAS REPORTEDLY DOING WELL POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19221363 ↗MalfunctionMay 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION, THE SAFFRON ANCHORS PULLED OUT ON BOTH SIDES WHEN ATTEMPTING TO TIE DOWN THE SUTURES. IT WAS FELT THAT THE ANCHORS WERE PROPERLY DEPLOYED AND IMPLANTED IN THE SSL [SACROSPINOUS LIGAMENT]. IT WAS NOTED THAT ONE OF THE ANCHORS HAD DEFORMED BARBS. THE ANCHORS WERE REPLACED WITH NEW SAFFRON ANCHORS WHICH HELD. THE PATIENT WAS REPORTEDLY DOING WELL POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19221201 ↗MalfunctionMay 1, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
ACCORDING TO THE AVAILABLE INFORMATION, THE SAFFRON ANCHORS PULLED OUT ON BOTH SIDES WHEN ATTEMPTING TO TIE DOWN THE SUTURES. IT WAS FELT THAT THE ANCHORS WERE PROPERLY DEPLOYED AND IMPLANTED IN THE SSL [SACROSPINOUS LIGAMENT]. IT WAS NOTED THAT ONE OF THE ANCHORS HAD DEFORMED BARBS. THE ANCHORS WERE REPLACED WITH NEW SAFFRON ANCHORS WHICH HELD. THE PATIENT WAS REPORTEDLY DOING WELL POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19221151 ↗InjuryDec 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION IT WAS REPORTED THAT DURING A PATIENT EXAMINATION, THE DOCTOR COULD FEEL WHAT APPEARED TO BE AN ANCHOR THAT HAD DETACHED OR COME OUT OF THE SACROUS SPINOUS LIGAMENT CAUSING APICAL PROLAPSE TO RECUR.
Patient problems: Prolapse
MAUDE report 18394366 ↗InjuryDec 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION IT WAS REPORTED THAT DURING A PATIENT EXAMINATION, THE DOCTOR COULD FEEL WHAT APPEARED TO BE AN ANCHOR THAT HAD DETACHED OR COME OUT OF THE SACROUS SPINOUS LIGAMENT CAUSING APICAL PROLAPSE TO RECUR.
Patient problems: Prolapse
MAUDE report 18394286 ↗
Other Fixation, non-absorbable or absorbable, for pelvic use devices
- Saffron 520340Coloplast A/S · Fixation, non-absorbable or absorbable, for pelvic use28 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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