Surgipro ll VP-900-XRecalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
All models of Surgipro ll (70)
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
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521039537), received between Sep 24, 2018 and Aug 18, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Break” (19 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
- Break19
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient4
- Insufficient Information3
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Break
Patient problems: Insufficient Information
MAUDE report 50311029 ↗MalfunctionAug 18, 2026Break
Patient problems: Insufficient Information
MAUDE report 50311003 ↗MalfunctionAug 18, 2026Break
Patient problems: Insufficient Information
MAUDE report 50310950 ↗MalfunctionMar 4, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, TWO SUTURE BROKE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21521247 ↗MalfunctionMar 3, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, TWO SUTURES BROKE. A NEW DEVICE WAS USED 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 21505090 ↗MalfunctionJan 30, 2025Break; Break
IT WAS REPORTED THAT DURING THE USE OF THE SUTURE, FOUR BOXES OF SUTURES WERE BROKEN, EACH ASSOCIATED WITH DIFFERENT LOT NUMBERS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21276699 ↗MalfunctionJan 30, 2025Break; Break
IT WAS REPORTED THAT DURING THE USE OF THE SUTURE, FOUR BOXES OF SUTURES WERE BROKEN, EACH ASSOCIATED WITH DIFFERENT LOT NUMBERS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21276251 ↗MalfunctionJan 4, 2025Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, SUTURES BROKE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21075046 ↗MalfunctionJan 4, 2025Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, SUTURES BROKE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21075044 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT DURING THE USE OF THE SUTURE, THERE WERE TWO OCCURRENCES OF BROKEN SUTURES, EACH ASSOCIATED WITH DIFFERENT LOT NUMBERS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21074666 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT DURING THE USE OF THE SUTURE, FOUR BOXES OF SUTURE THREADS BROKE, EACH ASSOCIATED WITH DIFFERENT LOT NUMBERS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21074664 ↗MalfunctionApr 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE, AT THE CORONARY ARTERY, THE THREAD AND NEEDLE SEPARATED WHILE IN USE AND BEFORE APPLICATION TO THE PATIENT. THE SUTURE LOOSENED. ANOTHER BOX WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19100015 ↗MalfunctionSep 26, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING AN OPEN MYOCARDIAL REVASCULARIZATION, IN THE MYOCARDIUM, THREE SUTURES WERE BROKEN. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15486639 ↗MalfunctionSep 16, 2021Break; Break
ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS GRAFT, THE THREAD OF THE DEVICE BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12484776 ↗MalfunctionFeb 10, 2020Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent
ACCORDING TO THE REPORTER, WHILE DOING VESSEL ANASTOMOSIS DURING CORONARY ARTERY BYPASS GRAFT, THE SUTURE AND NEEDLE DIVERGED AND THE NEEDLE BENDED IN TISSUE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9687166 ↗MalfunctionAug 26, 2019Break; Break
ACCORDING TO THE REPORTER, PRIOR TO A CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE, THE DEVICE'S THREAD BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8933106 ↗MalfunctionAug 15, 2019Break; Break
ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS GRAFT, THE SUTURE BROKEN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8900081 ↗MalfunctionJul 22, 2019Break; Break
ACCORDING TO THE REPORTER, DURING OPEN CORONARY ARTERY BYPASS GRAFTING PROCEDURE, THE THREAD OF 36 PRODUCTS BROKE. IT WAS REPLACED BY A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8811782 ↗MalfunctionDec 7, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A OPEN CORONARY ARTERY BYPASS GRAFTING PROCEDURE, WHILE SUTURING THE DEVICE NEEDLE BROKE. THEY THEN USED ANOTHER SUTURE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8141422 ↗MalfunctionSep 24, 2018Break; Break
ACCORDING TO THE REPORTER, THE THREAD BROKE PRIOR TO AN OPEN CORONARY ARTERY BYPASS SURGERY. THEY USED NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7901888 ↗
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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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