Recall MonitorHealth Products
Codman Disposable Perforator
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: Codman Disposable Perforator
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Codman Disposable Perforator | More than 10 numbers, contact manufacturer. | 26-1221 |
Issue
On April 2025, Integra issued a voluntary recall for the 14mm Codman® Disposable Perforators due to an inadequate weld (proud weld) on specific lots of 14mm Codman® Disposable Perforators that can potentially cause the product to disassemble (break/separate). To date, there have been no complaints or adverse events reported in relation to the 9mm and 11mm Codman® Disposable Perforators disassembly. Out of an abundance of caution, as the 9 and 11 mm perforators are manufactured using the same equipment and operating parameters that affected the 14mm Perforator, Integra has made the decision to expand the scope of the field action to include the 9mm and 11mm perforators.