Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting o
FDA device recall Z-2768-2020 · posted 2020-08-05 · Open, Classified
Recall details
- Recalling firm
- Covidien Llc
- Reason for recall
- This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
- Action taken
- Medtronic sent a letter notification to customers dated July 06, 2020 recalling effected lots of product. This letter instructed customers to discontinue use of the product and quarantine effected inventory. Customers were also instructed to return effected product and complete recall response forms accordingly.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FCG
- Quantity affected
- 375 units
- Distribution
- world wide distribution
- Date initiated
- 2020-06-26
- Date posted
- 2020-08-05
- Location
- Mansfield, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Beacon EUS Access System (K180037) | Covidien, LLC | 2018-04-26 |