Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model VLOCN004L UDI-DI: 20884521072579 Lot N0B0834Y Model VLOCN006L UDI-DI: 20884521068824 Lots N0B0660Y N0J0042Y N0J0896Y N1A0931Y N1C0644Y N1L0438Y N2E0205Y N2E0350Y Model VLOCN008L UDI-DI: 20884521073606 Lots N0B0787Y N0E0302Y N1C0706Y N1G0856Y Model VLOCN204L UDI-DI: 20884521072609 Lots N0B0001Y N0E0552Y N0G0568Y N0J0894Y Model VLOCN206L UDI-DI: 20884521068831 Lots N0B0957Y N0G0569Y N0J0933Y N0L0198Y N0M0714Y N1A0932Y N1C0558Y N1C0770Y N1F0047Y N1F0796Y N1G0758Y N1K0184Y N2E0270Y N2E0298Y N9L0954Y Model VLOCN208L UDI-DI: 20884521073774 Lots N0B0772Y N0E0990Y N0G0570Y N0J0870Y N1C0557Y N1F0109Y N1F0132Y N1G0101Y N1J0032Y Model VLOCN304L UDI-DI: 20884521072616 Lots N0B0833Y N0G0487Y Model VLOCN306L UDI-DI: 20884521072654 Lots N0B0851Y N0E0558Y N0G0719Y Model VLOCN308L UDI-DI: 20884521073811 Lot N0G0324Y
A medical device manufacturer is recalling Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOC due to Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the pot. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026