Recall Z-0201-2023— Covidien, LP

Name: FDA recall Z-0201-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-28

Class II · Ongoing

Class II FDA medical device recall by Covidien, LP, initiated 2022-09-28. It names one FDA 510(k) clearance: K111442. Product: Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L. 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..

Recalling firm: Covidien, LP
Classification: Class II
Status: Ongoing
Initiated: 2022-09-28
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

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·cleared 2011-06-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.