Beacon EUS Access System Needle Recalled Due to Cannula Detachment
Covidien is voluntarily recalling 269 Beacon EUS Access System needles because the cannula detached during procedures in three reported cases.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a device failure (cannula detachment) that resulted in a retained foreign object in one case, posing significant injury risks such as biliary leak and pain.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II voluntary recall for the Beacon EUS Access System Preloaded Access 135-degree Needle. The device is a sterile, single-use endoscopic ultrasound instrument manufactured by Covidien LLC. It consists of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and facilitate guidewire placement to locations of the gastrointestinal tract.
The recall was initiated following three customer reports that the device cannula detached during a procedure. In one of these instances, the detached cannula was not retrieved during the procedure. The source text identifies potential risks associated with a detached cannula, including delay in treatment, biliary leak, pain, and retained device fragments.
A total of 269 units were distributed worldwide. The affected units are identified by Model # DSA-135-01, UDI 10884521663527, and Lot numbers F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, and F2513453X. Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for further instructions.
The recalled product
- 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 guide
- Manufacturer
- Covidien Llc
- Affected units
- 269
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X
- F2510861X
- F2512341X
- F2512383X
- F2512493X
- F2513453X
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Covidien Llc 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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