Class 2 Device Recall Everflex selfexpanding peripheral stent

• Date Initiated by Firm: July 14, 2022
• Create Date: August 26, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1644-2022
• Recall Event ID: 90652
• PMA Number: P110023
• Product Classification: Stent, superficial femoral artery - Product Code NIP
• Product: EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
• Code Information: All Lot codes: 1) Model Number EVX35-08-060-120, GTIN 00763000052355; 2) Model Number EVX35-05-020-080, GTIN 00763000051655; 3) Model Number EVX35-05-020-120, GTIN 00763000051662; 4) Model Number EVX35-05-020-150, GTIN 00763000051679; 5) Model Number EVX35-05-040-080, GTIN 00763000051686; 6) Model Number EVX35-05-040-120, GTIN 00763000051693; 7) Model Number EVX35-05-040-150, GTIN 00763000051709; 8) Model Number EVX35-05-060-080, GTIN 00763000051716; 9) Model Number EVX35-05-060-120, GTIN 00763000051723; 10) Model Number EVX35-05-060-150, GTIN 00763000051730; 11) Model Number EVX35-05-080-080, GTIN 00763000051747; 12) Model Number EVX35-05-080-120, GTIN 00763000051754; 13) Model Number EVX35-05-080-150, GTIN 00763000051761; 14) Model Number EVX35-05-100-080, GTIN 00763000051778; 15) Model Number EVX35-05-100-120, GTIN 00763000051785; 16) Model Number EVX35-05-100-150, GTIN 00763000051792; 17) Model Number EVX35-05-120-080, GTIN 00763000051808; 18) Model Number EVX35-05-120-120, GTIN 00763000051815; 19) Model Number EVX35-05-120-150, GTIN 00763000051822; 20) Model Number EVX35-05-150-080, GTIN 00763000051839; 21) Model Number EVX35-05-150-120, GTIN 00763000051846; 22) Model Number EVX35-05-150-150, GTIN 00763000051853; 23) Model Number EVX35-06-020-080, GTIN 00763000051860; 24) Model Number EVX35-06-020-120, GTIN 00763000051877; 25) Model Number EVX35-06-020-150, GTIN 00763000051884; 26) Model Number EVX35-06-040-080, GTIN 00763000051891; 27) Model Number EVX35-06-040-120, GTIN 00763000051907; 28) Model Number EVX35-06-040-150, GTIN 00763000051914; 29) Model Number EVX35-06-060-080, GTIN 00763000051921; 30) Model Number EVX35-06-060-120, GTIN 00763000051938; 31) Model Number EVX35-06-060-150, GTIN 00763000051945; 32) Model Number EVX35-06-080-080, GTIN 00763000051952; 33) Model Number EVX35-06-080-120, GTIN 00763000051969; 34) Model Number EVX35-06-080-150, GTIN 00763000051976; 35) Model Number EVX35-06-100-080, GTIN 00763000051983; 36) Model Number EVX35-06-100-120, GTIN 00763000051990; 37) Model Number EVX35-06-100-150, GTIN 00763000052003; 38) Model Number EVX35-06-120-080, GTIN 00763000052010; 39) Model Number EVX35-06-120-120, GTIN 00763000052027; 40) Model Number EVX35-06-120-150, GTIN 00763000052034; 41) Model Number EVX35-06-150-080, GTIN 00763000052041; 42) Model Number EVX35-06-150-120, GTIN 00763000052058; 43) Model Number EVX35-06-150-150, GTIN 00763000052065; 44) Model Number EVX35-07-020-080, GTIN 00763000052072; 45) Model Number EVX35-07-020-120, GTIN 00763000052089; 46) Model Number EVX35-07-020-150, GTIN 00763000052096; 47) Model Number EVX35-07-040-080, GTIN 00763000052102; 48) Model Number EVX35-07-040-120, GTIN 00763000052119; 49) Model Number EVX35-07-040-150, GTIN 00763000052126; 50) Model Number EVX35-07-060-080, GTIN 00763000052133; 51) Model Number EVX35-07-060-120, GTIN 00763000052140; 52) Model Number EVX35-07-060-150, GTIN 00763000052157; 53) Model Number EVX35-07-080-080, GTIN 00763000052164; 54) Model Number EVX35-07-080-120, GTIN 00763000052171; 55) Model Number EVX35-07-080-150, GTIN 00763000052188; 56) Model Number EVX35-07-100-080, GTIN 00763000052195; 57) Model Number EVX35-07-100-120, GTIN 00763000052201; 58) Model Number EVX35-07-100-150, GTIN 00763000052218; 59) Model Number EVX35-07-120-080, GTIN 00763000052225; 60) Model Number EVX35-07-120-120, GTIN 00763000052232; 61) Model Number EVX35-07-120-150, GTIN 00763000052249; 62) Model Number EVX35-07-150-080, GTIN 00763000052256; 63) Model Number EVX35-07-150-120, GTIN 00763000052263; 64) Model Number EVX35-07-150-150, GTIN 00763000052270; 65) Model Number EVX35-08-020-080, GTIN 00763000052287; 66) Model Number EVX35-08-020-120, GTIN 00763000052294; 67) Model Number EVX35-08-020-150, GTIN 00763000052300; 68) Model Number EVX35-08-040-080, GTIN 00763000052317; 69) Model Number EVX35-08-040-120, GTIN 00763000052324; 70) Model Number EVX35-08-040-150, GTIN 00763000052331; 71) Model Number EVX35-08-060-080, GTIN 00763000052348; 72) Model Number EVX35-08-060-150, GTIN 00763000052362; 73) Model Number EVX35-08-080-080, GTIN 00763000052379; 74) Model Number EVX35-08-080-120, GTIN 00763000052386; 75) Model Number EVX35-08-080-150, GTIN 00763000052393; 76) Model Number EVX35-08-100-080, GTIN 00763000052409; 77) Model Number EVX35-08-100-120, GTIN 00763000052416; 78) Model Number EVX35-08-100-150, GTIN 00763000052423; 79) Model Number EVX35-08-120-080, GTIN 00763000052430; 80) Model Number EVX35-08-120-120, GTIN 00763000052447; 81) Model Number EVX35-08-120-150, GTIN 00763000052454; 82) Model Number EVX35-08-150-080, GTIN 00763000052461; 83) Model Number EVX35-08-150-120, GTIN 00763000052478; 84) Model Number EVX35-08-150-150, GTIN 00763000052485; 85) Model Number EVD35-07-040-080, GTIN 00821684051207; 86) Model Number EVD35-07-150-080, GTIN 00821684051252; 87) Model Number EVD35-06-020-150, GTIN 00821684051573; 88) Model Number EVR35-05-020-080, GTIN 00821684056332; 89) Model Number EVR35-05-040-080, GTIN 00821684056349; 90) Model Number EVR35-05-060-080, GTIN 00821684056356; 91) Model Number EVR35-05-080-080, GTIN 00821684056363; 92) Model Number EVR35-05-100-080, GTIN 00821684056370; 93) Model Number EVR35-05-120-080, GTIN 00821684056387; 94) Model Number EVR35-05-150-080, GTIN 00821684056394; 95) Model Number EVR35-06-020-080, GTIN 00821684056400; 96) Model Number EVR35-06-040-080, GTIN 00821684056417; 97) Model Number EVR35-06-060-080, GTIN 00821684056424; 98) Model Number EVR35-06-080-080, GTIN 00821684056431; 99) Model Number EVR35-06-100-080, GTIN 00821684056448; 100) Model Number EVR35-06-120-080, GTIN 00821684056455; 101) Model Number EVR35-06-150-080, GTIN 00821684056462; 102) Model Number EVR35-07-020-080, GTIN 00821684056479; 103) Model Number EVR35-07-040-080, GTIN 00821684056486; 104) Model Number EVR35-07-060-080, GTIN 00821684056493; 105) Model Number EVR35-07-080-080, GTIN 00821684056509; 106) Model Number EVR35-07-100-080, GTIN 00821684056516; 107) Model Number EVR35-07-120-080, GTIN 00821684056523; 108) Model Number EVR35-07-150-080, GTIN 00821684056530; 109) Model Number EVR35-08-020-080, GTIN 00821684056547; 110) Model Number EVR35-08-040-080, GTIN 00821684056554; 111) Model Number EVR35-08-060-080, GTIN 00821684056561; 112) Model Number EVR35-08-080-080, GTIN 00821684056578; 113) Model Number EVR35-08-100-080, GTIN 00821684056585; 114) Model Number EVR35-08-120-080, GTIN 00821684056592; 115) Model Number EVR35-08-150-080, GTIN 00821684056608; 116) Model Number EVR35-05-020-120, GTIN 00821684056615; 117) Model Number EVR35-05-040-120, GTIN 00821684056622; 118) Model Number EVR35-05-060-120, GTIN 00821684056639; 119) Model Number EVR35-05-080-120, GTIN 00821684056646; 120) Model Number EVR35-05-100-120, GTIN 00821684056653; 121) Model Number EVR35-05-120-120, GTIN 00821684056660; 122) Model Number EVR35-05-150-120, GTIN 00821684056677; 123) Model Number EVR35-06-020-120, GTIN 00821684056684; 124) Model Number EVR35-06-040-120, GTIN 00821684056691; 125) Model Number EVR35-06-060-120, GTIN 00821684056707; 126) Model Number EVR35-06-080-120, GTIN 00821684056714; 127) Model Number EVR35-06-100-120, GTIN 00821684056721; 128) Model Number EVR35-06-120-120, GTIN 00821684056738; 129) Model Number EVR35-06-150-120, GTIN 00821684056745; 130) Model Number EVR35-07-020-120, GTIN 00821684056752; 131) Model Number EVR35-07-040-120, GTIN 00821684056769; 132) Model Number EVR35-07-060-120, GTIN 00821684056776; 133) Model Number EVR35-07-080-120, GTIN 00821684056783; 134) Model Number EVR35-07-100-120, GTIN 00821684056790; 135) Model Number EVR35-07-120-120, GTIN 00821684056806; 136) Model Number EVR35-07-150-120, GTIN 00821684056813; 137) Model Number EVR35-08-040-120, GTIN 00821684056837; 138) Model Number EVR35-08-060-120, GTIN 00821684056844; 139) Model Number EVR35-08-080-120, GTIN 00821684056851; 140) Model Number EVR35-08-100-120, GTIN 00821684056868; 141) Model Number EVR35-08-120-120, GTIN 00821684056875; 142) Model Number EVR35-08-150-120, GTIN 00821684056882; 143) Model Number EVR35-05-040-150, GTIN 00821684056905; 144) Model Number EVR35-05-060-150, GTIN 00821684056912; 145) Model Number EVR35-05-120-150, GTIN 00821684056943; 146) Model Number EVR35-05-150-150, GTIN 00821684056950; 147) Model Number EVR35-06-060-150, GTIN 00821684056981; 148) Model Number EVR35-06-080-150, GTIN 00821684056998; 149) Model Number EVR35-06-120-150, GTIN 00821684057018; 150) Model Number EVR35-06-150-150, GTIN 00821684057025; 151) Model Number EVR35-07-040-150, GTIN 00821684057049; 152) Model Number EVR35-07-060-150, GTIN 00821684057056; 153) Model Number EVR35-07-120-150, GTIN 00821684057087; 154) Model Number EVR35-07-150-150, GTIN 00821684057094; 155) Model Number EVR35-08-040-150, GTIN 00821684057117; 156) Model Number EVR35-08-060-150, GTIN 00821684057124; 157) Model Number EVR35-08-100-150, GTIN 00821684057148; 158) Model Number EVR35-08-120-150, GTIN 00821684057155
• Recalling Firm/ Manufacturer: Medtronic Inc.; 4600 Nathan Ln N; Plymouth MN 55442-2890
• For Additional Information Contact: PVH Customer Service; 800-716-6700
• Manufacturer Reason for Recall: Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
• FDA Determined Cause: Other
• Action: In the United States (US) on 14-Jul-2022, a written Medical Device Correction letter was mailed via 2-day tracked delivery to all consignees who have received affected product according to Medtronic Records. Outside the United States (OUS), beginning on 14-Jul-2022 a written Medical Device Correction letter was delivered to consignees who have received potentially affected product according to Medtronic records via regionally approved methods. For both US and OUS customers the letter notified customers of the correction (IFU update), provided a video link that demonstrates the updated procedure, and provided customers a summary of reported complaints and potential harms. The letter states the following: In the unlikely event of a delivery system failure, where the stent is partially deployed and the thumbwheel is unable to rotate, the following steps may solve the issue to successfully deploy the stent: 1. Ensure that the safety locking pin is completely removed from the delivery system, and there is no slack in the system. 2. Separate the gray strain relief from the handle using an 11-blade scalpel to cut the gray strain relief on the top and bottom of the handle. Cut from the white tabs toward the handle. See Figure 1and Figure 2. Note: Do not cut beyond the white tabs. Cutting beyond the white tabs may cut into the catheter, causing damage to the catheter. 3. Use a hemostat to slide the strain relief down the catheter and away from the handle. See Figure 1and Figure 2. Caution: Failure to hold the delivery system in a fixed position may cause the stent to foreshorten or lengthen. 4. Locate the seam that runs along the length of the handle. Open the two halves of the handle by separating the halves at the open safety locking pin location. Use a hemostat if necessary. 5. Set aside the two halves of the handle. 6. Keep the inner shaft and delivery system stable. 7. Hold the gold isolation sheath with one hand, and use the other hand or a hemostat, to grip the cable
• Quantity in Commerce: 183964 devices
• Distribution: worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NIP and Original Applicant = MEDTRONIC VASCULAR INC