CODMAN® 821517Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® Disposable Catheter Passer · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780515500), received between Oct 24, 2023 and Jun 23, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Difficult to Insert1
- Difficult to Remove1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2025Break; Break
A FACILITY REPORTED THE PLASTIC TIP OF A DISPOSABLE CATHETER PASSER (ID 821517) BROKE OFF WITHIN THE PATIENT DURING SHUNT INSERTION.
Patient problems: Insufficient Information
MAUDE report 22310410 ↗MalfunctionMay 20, 2025Fracture; Fracture
A FACILITY REPORTED THAT THE TIP AT THE END OF A DISPOSABLE CATHETER PASSER ID(B)(6) BROKE OFF DURING SURGERY AND HAD TO BE REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM. NO ADDITIONAL SURGERY WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054099 ↗MalfunctionOct 24, 2023Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove
A FACILITY REPORTED THE WHEN TUNNELING USING A CATHETER PASSER (ID (B)(6)) IT WAS DIFFICULT TO INTRODUCE PERITONEAL CATHETER AND DIFFICULT TO REMOVE THE TUNNELER. NO PATIENT INJURY REPORTED; HOWEVER, THERE WAS A 30 MINUTES SURGICAL DELAY DUE TO PRODUCT PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17995304 ↗
Other Instrument, shunt system implantation devices
- CODMAN® 821515Integra Lifesciences Production Corporation · Instrument, shunt system implantation3 reports
- Integra® 990010Integra Neurosciences Implant (France) · Instrument, shunt system implantation2 reports
- CODMAN® 831325Integra Lifesciences Production Corporation · Instrument, shunt system implantation1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.