Maxon CVRecalls & reported problems across all models
Covidien LP · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 95
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 13 models of Maxon CV by Covidien LP in the FDA's device registry (GUDID). Together they are named in 95 adverse event reports in the FDA's MAUDE database, received between May 1, 2017 and Jul 2, 2026 — classified as 14 injuries, 81 malfunctions.
The most frequently reported specific device problem is “Break” (52 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 Maxon CV problems
Device problems
- Break52
- Detachment of Device or Device Component49
- Insufficient Device Problem Information3
- Appropriate Device Problem Term/Code Not Available1
- Component Missing1
- Detachment Of Device Component1
- Material Deformation1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- No Consequences Or Impact To Patient18
- Insufficient Information9
- No Known Impact Or Consequence To Patient9
- No Code Available6
- Unintended Radiation Exposure6
- No Patient Involvement4
- Foreign Body In Patient3
Maxon CV models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Maxon CV 8886 6124-11SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID24 reports
- Maxon CV 8886 6124-21SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID24 reports
- Maxon CV 8886 6122-21SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID14 reports
- Maxon CV 8886 6127-01SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID10 reports
- Maxon CV 8886 6145-01SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Maxon CV 8886 6134-31SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Maxon CV 8886 6149-21SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Maxon CV 8886 6139-11SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Maxon CV 8886 6147-21SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Maxon CV 8886 6127-11SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Maxon CV 8886 6131-11SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Maxon CV 8886 6148-11SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
- Maxon CV 8886 6165-23SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
Recent Maxon CV adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PANCREATIC HEAD TUMOR RESECTION (PANCREATICODUODENECTOMY), WHILE SUTURING THE PANCREATIC DUCT, THE NEEDLE DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25693148 ↗MalfunctionMay 15, 2026Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, WHILE PERFORMING DEBRIDEMENT AND SUTURING WITH AN ABSORBABLE SUTURE, THE CHILD HAD POOR COOPERATION AND THE SUTURE NEEDLE WAS SUBJECTED TO SIGNIFICANT EXTERNAL FORCE. THE PHYSICIAN FOUND THAT THE NEEDLE HAD FRACTURED. THE BROKEN NEEDLE WAS PROMPTLY LOCATED IN ITS ENTIRETY. THE DEPARTMENT THEN USED ANOTHER SUTURE OF THE SAME MODEL TO COMPLETE THE DEBRIDEMENT AND SUTURING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25188833 ↗MalfunctionApr 16, 2026Break
ACCORDING TO THE REPORTER, DURING A EMERGENCY TRAUMA SUTURING, THE NEEDLE BROKE. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896915 ↗MalfunctionMar 24, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PANCREATICODUODENECTOMY OR HILAR CHOLANGIOCARCINOMA, AFTER SUTURING IN CHOLEDOCHOJEJUNOSTOMY, SEVERAL NEEDLES DETACHED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS TAKEN OUT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24678628 ↗MalfunctionMar 24, 2026Detachment of Device or Device Component; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A PANCREATICODUODENECTOMY OR HILAR CHOLANGIOCARCINOMA, AFTER SUTURING IN CHOLEDOCHOJEJUNOSTOMY, SEVERAL NEEDLES DETACHED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS TAKEN OUT. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24678405 ↗MalfunctionMar 5, 2026Break
IT WAS REPORTED THAT DURING A PEDIATRIC URETERAL RECONSTRUCTION SURGERY, THE NEEDLE COMPONENT OF THE DEVICE BROKE. THE BROKEN NEEDLE WAS REMOVED LAPAROSCOPICALLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523795 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT DURING A PEDIATRIC URETERAL SUTURE LAPAROSCOPIC PROCEDURE, DURING THE SUTURING OF THE URETER, THE NEEDLE COMPONENT OF THE DEVICE BROKE. IT OCCURRED ON FOUR DEVICES. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506043 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT DURING A PEDIATRIC URETERAL SUTURE LAPAROSCOPIC PROCEDURE, DURING THE SUTURING OF THE URETER, THE NEEDLE COMPONENT OF THE DEVICE BROKE. IT OCCURRED ON FOUR DEVICES. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506039 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT DURING A PEDIATRIC URETERAL SUTURE LAPAROSCOPIC PROCEDURE, DURING THE SUTURING OF THE URETER, THE NEEDLE COMPONENT OF THE DEVICE BROKE. IT OCCURRED ON FOUR DEVICES. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506033 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT DURING A PEDIATRIC URETERAL SUTURE LAPAROSCOPIC PROCEDURE, DURING THE SUTURING OF THE URETER, THE NEEDLE COMPONENT OF THE DEVICE BROKE. IT OCCURRED ON FOUR DEVICES. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506032 ↗MalfunctionFeb 12, 2026Break
ACCORDING TO THE REPORTER, WHILE PERFORMING DEBRIDEMENT AND SUTURING WITH AN ABSORBABLE SUTURE, THE CHILD HAD POOR COOPERATION AND THE SUTURE NEEDLE WAS SUBJECTED TO SIGNIFICANT EXTERNAL FORCE. THE PHYSICIAN FOUND THAT THE NEEDLE HAD FRACTURED. THE BROKEN NEEDLE WAS PROMPTLY LOCATED IN ITS ENTIRETY. THE DEPARTMENT THEN USED ANOTHER SUTURE OF THE SAME MODEL TO COMPLETE THE DEBRIDEMENT AND SUTURING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24323650 ↗InjuryFeb 10, 2026Break
IT WAS REPORTED THAT DURING THYROID SURGERY, DURING SUBCUTANEOUS TISSUE SUTURING, THE NEEDLE BREAKAGE OCCURRED. THE NEEDLE TIP COULD NOT BE LOCATED AFTER PUNCTURE, AND THE SURGICAL TIME WAS EXTENDED BY MORE THAN 1 HOUR. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE.
Patient problems: Foreign Body In Patient; Unintended Radiation Exposure
MAUDE report 24307270 ↗MalfunctionJan 30, 2026Break
IT WAS REPORTED THAT DURING A PEDIATRIC CIRCUMCISION, WHILE PERFORMING SKIN SUTURING VIA CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE BROKE. A NEW SUTURE WAS USED TO COMPLETE THE STITCHING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221715 ↗MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, IN AN OPEN PROCEDURE, WHILE SUTURING THE INCISION USING THE CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE AND THREAD DETACHED. AN ADDITIONAL SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23804898 ↗MalfunctionDec 3, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
DUPLICATE OF (B)(4).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23706753 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
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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