CODMAN® 201037Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® RANEY Scalp Clips 20 Units of 10 Clips · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780511625), received between Sep 13, 2022 and May 28, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination” (2 reports).
1 FDA recall record name this device's identifier.
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
- Jun 1, 2021Terminated
Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
Z-2224-2021 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Contamination2
- Device Contaminated During Manufacture or Shipping1
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Melted; Melted
A FACILITY REPORTED A PHYSICIAN NOTICED THAT THE TRACE OF ONE OF THE SCALP CLIPS (ID 201037) WAS MELTING BEFORE SURGERY. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22098391 ↗MalfunctionMay 13, 2025Contamination; Contamination
A FACILITY REPORTED A HAIR WAS FOUND INSIDE THE STERILIZATION PACK DURING INSPECTION OF A SCALP CLIP (ID 201037). THE PRODUCT WAS STORED IN A WAREHOUSE (DISTRIBUTION CENTER). NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010874 ↗MalfunctionFeb 5, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
A FACILITY REPORTED A FOREIGN OBJECT INSIDE THE PACKAGING OF A SCALP CLIP (ID 201037) DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21316079 ↗MalfunctionSep 13, 2022Contamination; Contamination
A FACILITY REPORTED THE SCALP CLIPS (ID (B)(6)) HAD A HAIR MIXED-IN, AND THE INNER BAG WAS CAUGHT IN THE SEAL PART OF THE OUTER BAG. THE PRODUCT WAS STORED IN ITS ORIGINAL POUCH. NO PATIENT INJURY/INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15410429 ↗
Other CLIP, SCALP devices
- NA CM8902Medtronic Ps Medical, Inc. · CLIP, SCALP1 recall0 reports
- WECK IPN028499Teleflex Incorporated · CLIP, SCALP2 reports
- CODMAN 20-1037Cerenovus, Inc. · CLIP, SCALP2 reports
- AESCULAP FF013PAesculap AG · CLIP, SCALP1 report
- CODMAN® 201038Integra Lifesciences Production Corporation · CLIP, SCALP1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.