CODMAN® 801455Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® Surgical Strips 2" x 6" (51mm x 152mm) · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780515111), received between Dec 8, 2023 and Dec 8, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (K880402); they may or may not involve this specific model.
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
Recalls naming this device
- Sep 20, 2024Open, Classified
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Z-0254-2025 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Contamination /Decontamination Problem1
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.
MalfunctionDec 8, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
A FACILITY REPORTED A PARTICLE WAS VISIBLE IN A SURGICAL STRIP (ID 801455). ISSUE DETECTED PRIOR TO PATIENT USE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY, NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18292043 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K880402. One submission often covers many models, so check the product and lot details in each record.
- Z-0095-2011 · Jul 16, 2010 · TerminatedSurgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403
- Z-0093-2011 · Jul 16, 2010 · TerminatedCodman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396
- Z-0094-2011 · Jul 16, 2010 · TerminatedCodman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
Other Neurosurgical paddie devices
- CODMAN® 801400Integra Lifesciences Production Corporation · Neurosurgical paddie2 recalls9 reports
- CODMAN® 801407Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall6 reports
- MEDLINE NEUROSPNG05Medline Industries, Inc. · Neurosurgical paddie1 recall5 reports
- CODMAN® 801451Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall5 reports
- CODMAN® 801404Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall4 reports
- CODMAN® 801406Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 reports
- CODMAN® 801403Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 reports
- CODMAN 80-1407Cerenovus, Inc. · NEUROSURGICAL PADDIE1 recall2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.