SaffronRecalls & reported problems across all models
Coloplast A/S · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 2 models of Saffron by Coloplast A/S in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Nov 1, 2023 and May 8, 2026 — classified as 5 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (37 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. 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
Reports received per month, all models
Most reported Saffron problems
Device problems
- Device Dislodged or Dislocated37
- Break2
- Material Deformation2
- Adverse Event Without Identified Device or Use Problem1
- Device Difficult to Setup or Prepare1
- Improper or Incorrect Procedure or Method1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Prolapse4
- Neuralgia1
Saffron models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Saffron 520340Fixation, non-absorbable or absorbable, for pelvic use28 reports
- Saffron 520350Fixation, non-absorbable or absorbable, for pelvic use14 reports
Recent Saffron adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionAug 12, 2025Device Difficult to Setup or Prepare; Device Dislodged or Dislocated; Device Difficult to Setup or Prepare; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION THE SURGEON WAS PERFORMING AN ANTERIOR REPAIR WITH AXIS DERMIS GRAFT, ATTACHING IT TO THE SACROSPINOUS LIGAMENT WITH THE SAFFRON FIXATION TOOL USING 2-0 POLYPROPYLENE SUTURE. THE SURGEON IMPLANTED BOTH SUTURES IN THE SACROSPINOUS LIGAMENT; HOWEVER, BOTH THE SURGEON AND THE SCRUB TECH STRUGGLED TO HEAR THE REQUISITE CLICK OF THE ANCHOR BEING SEEDED INTO THE TOOL. THE PHYSICIAN DID NOT FEEL LIKE THE DEVICE WAS WORKING PROPERLY BUT HE PROCEEDED. HE TUGGED ON BOTH SUTURES, AND THEY APPEARED TO BE LODGED WITHIN THE LIGAMENT. WHEN HE WAS TYING THE SUTURES DOWN, THE ANCHOR ON THE PATIENT¿S RIGHT-SIDE LIGAMENT DISLODGED. THE PHYSICIAN REQUESTED ANOTHER SAFFRON TOOL BECAUSE HE DID NOT BELIEVE THE FIRST ONE WAS WORKING PROPERLY. THE CIRCULATOR OPENED A SECOND SAFFRON TOOL, WHICH WAS FROM THE SAME LOT. AGAIN, BOTH THE SCRUB TECH AND THE PHYSICIAN STRUGGLED TO HEAR THE CLICK. HE WAS ABLE TO GET THE ANCHOR IMPLANTED INTO THE SACROSPINOUS LIGAMENT WITH SUCCESS. THERE WAS NO EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786959 ↗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 ↗MalfunctionMar 12, 2024Material Twisted/Bent; Material Twisted/Bent
ACCORDING TO THE AVAILABLE INFORMATION THE SURGEON DEPLOYED THE DEVICE AND NOTED THAT IT WAS DIFFICULT TO REMOVE AFTER PLACING THE ANCHOR. AFTER EXAMINING THE DEVICE, IT WAS CONCLUDED THAT THE ANCHOR DEPLOYER WAS BENT AND UNABLE TO WITHDRAW BACK INTO HANDSET. SHE OPENED ANOTHER DEVICE AND COMPLETED CASE. IT WAS NOTED THERE WAS NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18888095 ↗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 ↗
Other Coloplast A/S products
All Coloplast A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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