The Recall Desk
HighFDA (Devices)·Z-1241-2022·Announced 2022-06-15

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.

What this means for you

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
Category
Medical Device — Vascular interventional device
Hazard
  • foreign-object
  • manufacturing-defect

Distribution

Distributed nationwide across the United States.

Related recalls

Same category