CODMAN® 821515Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® Disposable Catheter Passer · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780515487), received between Mar 21, 2025 and Dec 11, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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, 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
- Insufficient Device Problem Information3
Patient problems
- Hemorrhage/Blood Loss/Bleeding3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJun 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A PHYSICIAN REPORTED THAT DURING THE IMPLANTATION PROCEDURE, WHILE TUNNELING WITH A DISPOSABLE CATHETER PASSER (ID 821515), A VESSEL WAS INADVERTENTLY NICKED AND THE PATIENT EXPERIENCED BLEEDING. THE SURGEON MADE ANOTHER INCISION TO LOCATE THE SOURCE, APPLIED DIRECT PRESSURE, AND CAUTERY WAS USED TO ACHIEVE HEMOSTASIS. THIS RESOLVED THE ISSUE. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THERE IS ANY ISSUE WITH THE CATHETER PASSER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO DEVICE ISSUE, OR IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO BLOOD LOSS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22283718 ↗InjuryMar 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A PHYSICIAN REPORTED THAT DURING THE IMPLANT PROCEDURE, WHILE TUNNELING WITH A CODMAN CATHETER PASSER (ID 347674), A VESSEL WAS NICKED AND THE PATIENT EXPERIENCED BLEEDING. THE PHYSICIAN LOCATED THE BLEED, APPLIED PRESSURE, AND LIGATED THE VESSEL TO ACHIEVE HEMOSTASIS. THIS RESOLVED THE ISSUE. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THERE IS ANY ISSUE WITH THE CATHETER PASSER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO DEVICE ISSUE, OR IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO BLOOD LOSS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21664948 ↗
Other Instrument, shunt system implantation devices
- CODMAN® 821517Integra 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.