Endo Stitch V-Loc surgical sutures recalled due to needle breakage
Covidien is recalling Endo Stitch V-Loc PBT non-absorbable surgical sutures due to 210 reports of needles breaking during use. Breaking needles may leave fragments in patients, potentially causing tissue injury or requiring additional imaging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall with 210 documented reports of needle breakage during actual clinical use. Although no hospitalizations or injuries are reported in the recall notice, the potential for serious harm—including retained needle fragments, tissue injury, and need for additional imaging—is significant, placing this in the risk-of-harm category without documented injury.
Plain-English summary
Covidien, LP is recalling Endo Stitch V-Loc PBT Non-Absorbable Reload surgical sutures (Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L) due to needle breakage during use. Approximately 30,658 units have been distributed domestically and internationally.
Mediatronic has received 210 reports of needles breaking during endoscopic suturing procedures. When needles break, fragments may remain in the patient, creating the potential for complications including foreign body reactions, allergic reactions, tissue injury, and the need for additional imaging procedures to locate and retrieve fragments.
Healthcare providers and hospitals should immediately stop using affected units. Patients who have undergone procedures using these sutures should consult their healthcare provider if they have any concerns about their treatment or potential complications from the procedure.
The recalled product
- Product
- Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
- Manufacturer
- Covidien, LP
- Category
- Medical Device — Surgical Suture
- Affected units
- 30,658
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien, LP 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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