Covidien, LP: 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.

Model VLOCA004L UDI-DI: 20884521068084 Lots N1G0268Y N9M0756Y Model VLOCA006L UDI-DI: 20884521068091 Lots N0D0586Y N0H0178Y N1A0817Y N1B0531Y N1E0104Y N1E0747Y N1F0714Y N1H0583Y N1J0848Y N2D0068Y N2D0077Y N2D0240Y Model VLOCA008L UDI-DI: 20884521068275 Lots N0A0577Y N0C0316Y N0D0001Y N0D0106Y N0D0397Y N0D0398Y N0E0682Y N0F0368Y N0F0758Y N0F0969Y N0G0972Y N0J1022Y N0J1023Y N0K0723Y N0K1031Y N0L0127Y N0L0128Y N0M0360Y N0M0513Y N1A0199Y N1A0660Y N1A0816Y N1A0958Y N1B0110Y N1B0750Y N1C0088Y N1C0398Y N1C0495Y N1D0528Y N1D0697Y N1D0853Y N1E0102Y N1E0103Y N1F0035Y N1F0182Y N1G0107Y N1G0404Y N1G0628Y N1H0234Y N1H0677Y N1J0440Y N1K0248Y N1K0306Y N1K0867Y N1L0592Y N1L0766Y N1M0720Y N1M0731Y N2A0468Y N2B0095Y N2B0188Y N2B0289Y N2C0008Y N2C0009Y N2C0032Y N2C0495Y N2C0683Y N2D0813Y N2D0814Y N9K1167Y N9K1169Y N9L0102Y N9L0103Y N9L0503Y N9L0966Y N9M0077Y Model VLOCA204L UDI-DI: 20884521068114 Lots N0C0212Y N0J0294Y Model VLOCA206L UDI-DI: 20884521068121 Lots N0C0307Y N0D0105Y N0D0326Y N0D0327Y N0D0587Y N0E0718Y N0E0979Y N1A0502Y N1E0748Y N1F0701Y N1F0915Y N1G0759Y N1H0058Y N1H0803Y N1K0185Y N1M0276Y N2C0524Y N2D0233Y N2D0444Y N2D0445Y Model VLOCA208L UDI-DI: 20884521068282 Lots N0A0201Y N0C1103Y N0D0498Y N0D0506Y N0F0759Y N0G0279Y N0G0280Y N0H0960Y N0K0671Y N0K0672Y N0M0315Y N0M0393Y N1A0156Y N1A0501Y N1B0084Y N1B0263Y N1B0560Y N1C0728Y N1E0462Y N1E0508Y N1F0048Y N1F0556Y N1G0123Y N1G0442Y N1H0056Y N1H0257Y N1H0666Y N1H0901Y N1J0216Y N1J0510Y N1J0850Y N1K0164Y N1L0069Y N1L0494Y N1L0672Y N2A0110Y N2B0148Y N2E0299Y N9K1182Y N9L0093Y N9L0502Y N9L0737Y N9L0738Y N9L0761Y N9M0758Y Model VLOCA304L UDI-DI: 20884521068138 Lots N0B0409Y N0D0405Y N0F1041Y N0J0293Y Model VLOCA306L UDI-DI: 20884521068152 Lots N0A0239Y N0A0527Y N0F0833Y N0H1087Y N1F0811Y N1G0287Y N1G0763Y N1K0247Y N2B0322Y N2C0682Y N2D0302Y N2D0552Y N9J0258Y N9M0757Y Model VLOCA308L UDI-DI: 20884521068787 Lots N0A0383Y N0K0988Y N1G0106Y N1G0551Y N1L0085Y N1L0162Y N2C0509Y

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