CODMAN 80-1403Recalls & reported problems
Cerenovus, Inc. · CODMAN Surgical Patties 1 Inch x 1 Inch (2.54cm x 2.54cm) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
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 20886704036514), received between Jul 17, 2020 and Jul 17, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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.
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-0242-2025 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page