Recall Z-0200-2023 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Covidien, LP
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
| Date | Nov 11, 2022 (initiated Sep 28, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| 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. |
| Quantity | 117978 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111442 | V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... Covidien, Formerly US Surgical A Divison of Tyco H, Jun 3, 2011 |