Surgipro II VP-735-XRecalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
All models of Surgipro II (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521038813), received between Apr 27, 2017 and Aug 8, 2024 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Break” (8 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Dec 2, 2022Class IIOpen, Classified
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Z-1180-2023 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break8
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
- Tissue Damage1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING FOR ALL 5 DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE DEVICE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19944599 ↗MalfunctionAug 8, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING FOR ALL 5 DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE DEVICE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19944332 ↗MalfunctionAug 7, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING FOR ALL 5 DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19931619 ↗MalfunctionAug 7, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING FOR ALL 5 DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19931535 ↗MalfunctionAug 7, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING FOR ALL FIVE DEVICES. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19931403 ↗MalfunctionJul 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN MYOCARDIAL REVASCULARIZATION PROCEDURE, AN ENVELOPE OF THE SUTURE WAS OPENED AND WHEN REMOVING THE PRODUCT FROM THE PACKAGE, THE NEEDLE WAS LOOSE FROM THE WIRE. THEN, DURING THE BEGINNING OF THE CORONARY ANASTOMOSIS WITH THE SUTURE, AT THE FIRST PASSAGE OF THE NEEDLE INTO THE CORONARY TISSUE, THE THREAD DETACHED FROM THE NEEDLE. IT WAS NECESSARY TO RESTART THE SUTURE WITH A NEW NEEDLE PASSAGE THROUGH THE CORONARY ARTERY TISSUE. AN ADDITIONAL SUTURE FROM THE SAME BATCH WAS USED WITHOUT ISSUE. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17317470 ↗MalfunctionAug 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT, THE FIRST TWO SUTURES WERE RUPTURED FROM THE SWAGE AND THE SECOND TWO SUTURES WERE RUPTURED FROM THE MIDDLE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15249991 ↗MalfunctionJul 21, 2020Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10301505 ↗MalfunctionJan 16, 2019Break; Break
ACCORDING TO THE REPORTER, DURING A BYPASS PROCEDURE, THE THREAD AND THE NEEDLE BROKE. THEY CHANGED SUTURE AND SUTURED AGAIN. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8255403 ↗MalfunctionJul 12, 2018Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT ON THE SAPHENOUS VEIN, THE SUTURE DETACHED FROM THE NEEDLE AND STRAND ON VESSEL ANASTOMOSIS. A NEW DEVICE WITH THE SAME LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7682793 ↗InjuryApr 27, 2017Break; Break
ACCORDING TO THE REPORTER: DURING CABG TRIPLE GRAFT WITH LAD LIMA CONNECTION (OPEN PROCEDURE), SUTURES THREADS BROKE WHEN THE SURGEON THREW AN KNOT WHILE PERFORMING DISTAL ANASTOMOSIS. SUTURE WAS HYDRATED TO MAKE PASSAGE SMOOTH. THE SURGEON EMPLOYED CONTINUOUS SUTURING TECHNIQUE. THE PATIENT HAS TO BE SHIFTED FROM BEATING HEART TO ON PUMP SURGERY BECAUSE OF CONTINUOUS BREAKING OF DISTAL ANASTOMOSIS SUTURE WHICH TRIGGERED THE BLOOD PRESSURE OF THE PATIENT TO PREVENT PERMANENT IMPAIRMENT OF A FUNCTION SO IT LED TO EXTENSION IN SURGICAL TIME UP TO 2 HOURS. THE DEVICE WAS BEING APPLIED TO SAPHENOUS VEIN. THERE WAS UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM. THERE WAS TISSUE DAMAGE DUE TO CONTINUOUS NEEDLE PRICK AS THE THREAD WAS BREAKING CONTINUOUSLY SO SURGEON HAD TO HARVEST ANOTHER VEIN FOR THE ADDITIONAL GRAFT AS A RESULT OF THIS PROBLEM. USED ANOTHER SUTURE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. PATIENT WAS TEMPORARILY INJURED.
Patient problems: Tissue Damage
MAUDE report 6525343 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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