Beacon EUS Access System Needle Recalled Due to Cannula Detachment
Covidien is voluntarily recalling 375 units of the Beacon EUS Access System Preloaded Access 90-degree Needle because the cannula may detach during procedures.
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 structural defect where a device component detaches and remains in the patient, posing a risk of retained foreign bodies and biliary leaks.
Plain-English summary
The U.S. Food and Drug Administration has issued a Class II recall for the Beacon EUS Access System Preloaded Access 90-degree Needle, manufactured by Covidien LLC. This sterile, single-use endoscopic ultrasound device 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 voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one reported 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.
The recall affects 375 units of Model # DSA-090-01 (UDI: 10884521722583) with lot numbers F2510370X, F2510900X, F2512340X, F2512378X, F2512492X, F2512620X, and F2513452X. The product was distributed worldwide. Healthcare providers and consumers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Beacon EUS Access System Preloaded Access 90degree 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 guidew
- Manufacturer
- Covidien Llc
- Affected units
- 375
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 (7)
- Model # DSA-090-01 UDI: 10884521722583 Lot #: F2510370X
- F2510900X
- F2512340X
- F2512378X
- F2512492X
- F2512620X
- F2513452X
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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