Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
Recall
- Recall Number
- Z-0200-2023
- Event Number
- 90892
- FEI Number
- 1219930
- Product Code
- GAM
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 28, 2022
- Posted
- November 11, 2022
- Address
- LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908
Description
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
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.
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.
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
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