Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-10-09FDA-DeviceHelena Laboratories, Corp.Class IICascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
- 2019-10-09FDA-DeviceHowmedica Osteonics Corp.Class IITRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
- 2019-10-09FDA-DeviceHowmedica Osteonics Corp.Class IITRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB) Catalog # 5542-A-201 - Product Usage:
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
- 2019-10-09FDA-DeviceHowmedica Osteonics Corp.Class IITRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
- 2019-10-09FDA-DeviceHowmedica Osteonics Corp.Class IITRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5 SH, .070", REF SA6JR45SH. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL355. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.75 SH, .070", REF SA6MAC375SH. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0 SH, .070", REF SA6EBU50SH. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL205. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F SAR2.0 .070", REF SA6SAR20. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5, .070", REF SA6SAL15. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL, .070", REF SA6ELGAMAL. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0 SH, .070", REF SA6JR60SH. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5 SH, .070", REF SA6SCR35SH. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5 SH, .070", REF SA6CHAMP15SH. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F JCL4.0, .070", REF SA6JCL40. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL405. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0, .070", REF SA6ECR40. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- 2019-10-09FDA-DeviceMedtronic VascularClass ISHERPA NX ACTIVE GUIDING CATHETER, 6F SCR5.0, .070", REF SA6SCR50. for cardiovascular use
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
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