Cook Nester Embolization Microcoil recalled for unintended cannula defect
Cook Incorporated recalls Nester Embolization Microcoil devices whose loading cartridges may contain an unintended stainless-steel cannula. Affected devices were distributed domestically and worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a manufacturing defect (unintended foreign object) that poses a risk of harm. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are scored 3 (High).
Plain-English summary
Cook Incorporated is recalling the Nester Embolization Microcoil, a medical device used in vascular interventional procedures. Multiple device models and lot numbers are affected by this recall.
The recall was initiated after it was determined that loading cartridges included with affected devices may contain a small, unintended stainless-steel cannula. This foreign object should not be present in the loading cartridges.
The affected devices were distributed both domestically throughout the United States and internationally worldwide.
The recalled product
- Product
- Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342…
- Manufacturer
- Cook Incorporated
- Affected units
- 106,033
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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