Recall Z-2769-2020
Covidien Llc · initiated June 26, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
Codes / lots: Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-2769-2020
- Initiated
- June 26, 2020
- Posted by FDA
- August 5, 2020
- Product code
- FCG – Biopsy Needle
- Quantity
- 269 units
- Distribution
- world wide distribution
- Recalling firm
- Covidien Llc, Mansfield, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2768-2020 Class II | Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use…This voluntary recall is being conducted following three customer reports of the device cannula detaching… | 06/26/2020Open, Classified |