Surgipro SP-684Recalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Surgipro SP-684 is a nonabsorbable polypropylene surgical suture. Most of the 35 reports describe the needle coming loose from the suture thread during handling or surgery, and sometimes the suture breaking. There are 33 malfunctions, 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
- 35
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10884521037489), received between Aug 13, 2017 and Jul 16, 2026 — classified as 2 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (28 reports).
1 other recall cover devices cleared under the same FDA submission (K954808); 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
- Detachment of Device or Device Component28
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Known Impact Or Consequence To Patient5
- No Consequences Or Impact To Patient3
- Insufficient Information2
- Foreign Body In Patient1
- No Patient Involvement1
- Radiation Exposure, Unintended1
- Unintended Radiation Exposure1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25838776 ↗MalfunctionJan 7, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO USE, THE NEEDLE DETACHED FROM THE SUTURE WHILE REMOVING IT FROM THE RETAINER AND PREPARING THE SUTURE PRIOR TO PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23999347 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST AUGMENTATION AND REDUCTION, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476416 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST AUGMENTATION AND REDUCTION, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476235 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST AUGMENTATION AND REDUCTION, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23475611 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST AUGMENTATION AND REDUCTION, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23475531 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST AUGMENTATION AND REDUCTION, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23474163 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST AUGMENTATION AND REDUCTION, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23474145 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST AUGMENTATION AND REDUCTION, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23474134 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST AUGMENTATION AND REDUCTION, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23473786 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST AUGMENTATION AND REDUCTION, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23473624 ↗MalfunctionNov 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST AUGMENTATION AND REDUCTION, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23467185 ↗MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST AUGMENTATION AND REDUCTION, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23422861 ↗MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SKIN CLOSURE OF THE FACE, WHEN CLOSING THE SKIN, IN THE ACT OF TAKING THE SUTURE FROM THE PACKET, NEEDLE DETACHMENT OCCURRED FOR FIVE SUTURES. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE SUTURE TYPE WAS CHANGED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23395274 ↗MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SKIN CLOSURE OF THE FACE, WHEN CLOSING THE SKIN, IN THE ACT OF TAKING THE SUTURE FROM THE PACKET, NEEDLE DETACHMENT OCCURRED FOR FIVE SUTURES. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE SUTURE TYPE WAS CHANGED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393932 ↗MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SKIN CLOSURE OF THE FACE, WHEN CLOSING THE SKIN, IN THE ACT OF TAKING THE SUTURE FROM THE PACKET, NEEDLE DETACHMENT OCCURRED FOR FIVE SUTURES. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE SUTURE TYPE WAS CHANGED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393856 ↗MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SKIN CLOSURE OF THE FACE, WHEN CLOSING THE SKIN, IN THE ACT OF TAKING THE SUTURE FROM THE PACKET, NEEDLE DETACHMENT OCCURRED FOR FIVE SUTURES. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE SUTURE TYPE WAS CHANGED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392854 ↗MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SKIN CLOSURE OF THE FACE, WHEN CLOSING THE SKIN, IN THE ACT OF TAKING THE SUTURE FROM THE PACKET, NEEDLE DETACHMENT OCCURRED FOR FIVE SUTURES. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. THE SUTURE TYPE WAS CHANGED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392715 ↗MalfunctionJul 16, 2025Break; Break
ACCORDING TO THE REPORTER, DURING AN EXCISION OF LESIONS, THE SUTURE BROKE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22520193 ↗InjuryJan 29, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A SUBTOTAL GASTRECTOMY, DURING SKIN CLOSURE, THE NEEDLE TIP BROKE OFF FROM ONE OF THE SIX SUTURES USED. IT WAS NOTED THAT THE BROKEN TIP WAS SEARCHED ON THE STERILE FIELD, AND A MAGNET ROLLER WAS USED OUTSIDE THE SURGICAL FIELD. AN INTRAOPERATIVE X-RAY WAS PERFORMED, AND NO ABNORMALITY WAS DETECTED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Foreign Body In Patient; Unintended Radiation Exposure
MAUDE report 21265067 ↗MalfunctionNov 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE SEPARATED FROM THE SUTURE UPON MANIPULATION OF THE PRODUCT. A NEW SUTURE FROM ANOTHER COMPANY WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662828 ↗MalfunctionNov 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE SEPARATED FROM THE SUTURE UPON MANIPULATION OF THE PRODUCT. A NEW SUTURE FROM ANOTHER COMPANY WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20591709 ↗MalfunctionMay 22, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURES WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 16981903 ↗MalfunctionJul 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, AT THE END OF A LAPAROSCOPIC CHOLECYSTECTOMY AND STARTING TO PREPARE THE SUTURES FOR THE PATIENT'S SKIN CLOSURE, THE NEEDLE WAS DETACHED FROM THE THREAD JUST BY UNCOVERING THEM AND REMOVING THEM FROM THEIR PACKAGING. TO RESOLVE THE ISSUE, ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12156831 ↗MalfunctionApr 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE PACKAGING WAS OPENED, THE NEEDLE WAS FOUND DISASSEMBLED. THE NEEDLE CAME OFF THE THREAD. ANOTHER DEVICE FROM THE SAME LOT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11742854 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K954808. One submission often covers many models, so check the product and lot details in each record.
- Z-1179-2023 · Dec 2, 2022 · Open, ClassifiedSurgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
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- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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