Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VL
Summary
The FDA issued a Class II for Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN0 by Covidien, LP. Reason: Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the pot.
Details
Source
Device Recall
External ID
Z-0201-2023
Action Date
2022-11-23
Status
Ongoing
Category
device
Product Description
Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
Lot/Code Info: 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
Quantity Affected: 30658
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.
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 Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-28
Company
North Haven, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien, LP has 89 FDA actions in our database, including 89 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien, LP have FDA actions?
Covidien, LP has 89 FDA actions in our database, including 89 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0201-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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