Endo Stitch V-Loc 180 Sutures Recalled for Needle Breakage During Use
Covidien recalls Endo Stitch V-Loc 180 automated suturing devices due to 210 reports of needles breaking during endoscopic surgery. Broken needle fragments may remain in patients, potentially causing tissue injury and 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: This is an FDA Class II medical device recall with 210 reports of needle breakage during actual use, but no confirmed hospitalizations or injuries. Per the rubric, it qualifies as a risk-of-harm product where injury has not yet been reported, scoring High (3).
Plain-English summary
Covidien, LP is recalling the Endo Stitch V-Loc 180 Absorbable Reload, an automated suturing device used during endoscopic procedures. Approximately 117,978 units have been distributed nationwide and to over 40 countries.
The recall is due to 210 reports of needles breaking during endoscopic suturing procedures. The potential harms include delays in treatment or therapy, needle fragments remaining in the patient, foreign body reactions, allergic reactions, tissue injury, and unintended radiation exposure from additional imaging during surgical and post-operative care.
No illnesses or injuries related to these incidents have been reported to date.
The recalled product
- Product
- Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
- Manufacturer
- Covidien, LP
- Hazard
- needle-breakage
- retained-foreign-body
- tissue-injury
Distribution
Distributed nationwide across the United States.
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