Covidien recalls Endo Stitch V-Loc PBT Non-Absorbable Reload models due to reports of needles breaking during endoscopic suturing, which may cause delays, retained needle fragments, or tissue injury.
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.
Covidien is recalling specific models of Endo Stitch V-Loc PBT Non-Absorbable Reload sutures because needles have broken during surgery. This could lead to delayed treatment, retained needle fragments, tissue injury, or allergic reactions. Affected users should stop using these products immediately.
During endoscopic suturing, the needles in these sutures can break, potentially causing delays in treatment. If a needle fragment remains in the patient, it could lead to tissue injury, allergic reactions, or require additional imaging for detection.
Patients undergoing endoscopic procedures who use the recalled sutures are most at risk. Healthcare providers who have these specific models in their inventory may also be affected.
Check the product label for model numbers VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, or VLOCN308L. The specific lot numbers listed in the recall notice also indicate affected units.
Immediately stop using the recalled Endo Stitch V-Loc PBT Non-Absorbable Reload sutures if you have them.
The affected models are VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, and VLOCN308L.
Medtronic has received 210 reports of needles breaking during endoscopic suturing, which could cause delays in treatment, retained needle fragments, tissue injury, or allergic reactions.
Check the product label for the model numbers listed in the recall notice, which include VLOCN004L through VLOCN308L. The specific lot numbers provided in the recall also indicate affected units.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0201-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0201-2023 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
