Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
FDA Recall Z-0201-2023 · Posted 2022-11-11
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Recalling FirmCovidien, LP
Recall StatusOpen, Classified
Product CodeGAM
Date Initiated2022-09-28
Product Quantity30658
Reason for Recall
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.
Firm Action
Beginning 28-September-2022 communications to all affected consignees
began.
Consignees are asked to return any affected product they may have,
forward this notification to those who need to be aware within the
organization and to any location which the devices have been transferred.
Consignees are asked to complete and return a confirmation certificate (or
equivalent record) confirming they have received the notification.
Root Cause
Process control
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Canada Canary Islands Chile Croatia Cyprus Denmark Egypt Finland France Germany Greece Hungary Ireland Israel Italy Jordan Kazakhstan Kuwait Lithuania Luxembourg Mexico Netherlands New Zealand Norway Poland Portugal Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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