CODMAN® 9190001RPRecalls & reported problems
Integra LifeSciences Switzerland Sàrl · CODMAN® Integrated Bipolar Cord and Tubing Set Fixed Leads, Rotary Pump · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780521747), received between Jan 28, 2025 and Jan 28, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
A FACILITY REPORTED A "FOREIGN MATTER" WAS OBSERVED INSIDE THE PACKAGING OF A DISPOSABLE CODMAN CORD AND TUBING (ID 9190001RP). THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY/CONSEQUENCES. ACCORDING TO CUSTOMER, THERE IS NO FURTHER INFORMATION ON THE FOREIGN MATTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21253405 ↗
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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
- 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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