Brachytherapy Applicator Advanced Gynecological Applicator Tip Detachment
Elekta, Inc. is recalling Advanced Gynecological Applicators due to potential detachment of the intrauterine tube tip, which may remain inside a patient during cancer treatment.
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 FDA classified this as a Class II medical device recall involving a structural defect (tip detachment) that could result in a device component remaining inside a patient, posing potential harm during a critical cancer treatment procedure. Although no reported injuries are stated in the source, the risk of retained foreign material in a patient meets the Severe threshold for Class II recalls with risk of serious harm.
Plain-English summary
Elekta, Inc. is recalling the Advanced Gynecological Applicator (Brachytherapy Applicator) due to safety concerns regarding detachment of the intrauterine tube (IU tube) tip. The tip may separate and remain within a patient during or after the device is used.
The Advanced Gynecological Applicator is intended for intracavitary brachytherapy treatment of cervical and endometrial cancers, with optional needles available for interstitial brachytherapy. Approximately 586 units have been distributed worldwide across the United States and numerous international locations.
Affected lot codes include: 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, and 08717213055131. Healthcare providers and patients who have received or used these devices should contact Elekta, Inc. or the FDA for guidance on appropriate actions.
The recalled product
- Product
- Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed
- Manufacturer
- Elekta, Inc.
- Hazard
- device-detachment
- retained-foreign-material
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 (11)
- Lot Code: 08717213055001
- 08717213055018
- 08717213055025
- 08717213055049
- 08717213055056
- 08717213055063
- 08717213055087
- 08717213055094
- 08717213055100
- 08717213055117
- 08717213055131
Distribution
Distributed nationwide across the United States.
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