Medtronic Cardiovascular Revascularization & Surgical Therap: Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradiation. The U-Clip consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools. The Coalescent Surgical U-CLIP is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

Recall number

Z-2030-2010

Recalling firm

Medtronic Cardiovascular Revascularization & Surgical Therap

Product

Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradiation. The U-Clip consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools. The Coalescent Surgical U-CLIP is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

Status

Terminated

Initiated

2010-04-02

Posted

2010-07-17

Terminated

2011-12-17

Reason

Medtronic received reports involving the V100D U-Clip where during handling, the release mechanism has become separated from the needle assembly. These instances of separation have occurred when pulling the clip through prosthetic material, or when grasping and releasing the clip using robotic instrumentation. While this issue does not impact performance of the clip once implanted, separation of

Root cause

Other

Action

The firm, Medtronic CardioVascular, sent an "Urgent Medical Device Recall Notice", dated April 2, 2010, to Risk Managers of each affected account. The letter described the issue, identified affected product, and the action to be taken by customers. The customers were ask to immediately discontinue use of affected devices and to quarantine all unused V100D U-Clip inventory. The letter stated that a Medtronic representative will contact the account to arrange return of the V100D U-Clips devices and that credit will be issued upon return of unused devices. Medtronic has stopped manufacture of the product therefore replacements will not be available. Devices can be returned to Medtronic CardioVascular, 7611 Northland Drive, Brooklyn Park, MN 55428. The customers were ask to please fill out the Medtronic Recall Certificate and fax it to 651-367-2620. If you need additional information, please contact CardioVascular LifeLine Technical Services at 877-526-7890, or you local Medtronic sales representative.

Quantity

22,946 ( 20,714 US, 2,232 OUS)

Distribution

Worldwide distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and countries of Australia, Belgium, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Japan, Korea, Netherlands, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Venezuela.

Lot, serial or model codes

Lot numbers: 0509537, 0509640, 509755, 0510102, 0511801, 0512206, 0512406, 0512528, 0516564, 0516805, 0517446, 0517447, 0518048, 0518149, 0518643, 0518701, 0519441, 0519442, 0519552, 0519553, 0520004, 0520005, 0520218, 0520219, 0520929, 0520930, 0523108, 0523109, 0523529, 0523629, 0525614, 0525615, 0525722, 0526317, 0526330, 0526518, 0526519, 0527001, 0529801, 0529802, 0529914, 0530028, 0530029, 0530101, 0530102, 0530103, 0530104, 0530105, 0530602, 0530707, 0530802, 0532125, 0532126, 0532127, 0532128, 0532630, 0532719, 0532735, 0532829, 0532904, 0532905, 0532907, 0533301, 0533335, 0533401, 0533421, 0533509, 0533537, 0533538, 0534017, 0534123, 0534124, 0534125, 0534126, 0534201, 0600501, 0600502, 0600931, 0600932, 0601119, 0601120, 0601333, 0601334, 0601601, 0601602, 0601703, 0602303, 0602304, 0603017, 0603018, 0603105, 0603205, 0603206, 0603207, 0604414, 0604415, 0605106, 0605107, 0605403, 0606601, 0607201, 0607202, 0607903, 0607904, 0608607, 0614210, 0623313, 0623606, 0623607, 0625412, 0625708, 0626201, 0626202, 0626203, 6036442, 6036670, 6109808, 6109921, 6109955, 6110083, 6138406, 6185510, 6197801, 6197828, 7004186, 7132081, 7146061, 7147793, 7147806, 7352981, 7451269, 7460608, 7479974, 7589735, 7639747, 7661223, 7681451, 7972937, 7979266, 8189696, 8277354, 8289638, 8306418, 8393857, 8521396, 8591790, 8629823, 8646480, 8675184, 8792196, 8898855, 9018451, 9036333, 9145329, 9156757, 9264475, 9323332, 9343587, 9381161, 9498440, 9498589, 9522139, 9569658, 9569711, 9598408, 9602041, 9603836, 9632400, 9685157, 9693616, 9695953, 9695961, 9695988, 9739629, 9739670, 9769262, 9779938, 9790387, 9790395, 9806955, 9806964, 9806969, 9806972, 9806974, 9807053, 9822530, 9855639, 9856396, 9861501, 9866062, 9867454, 9868936, 9872244, 9872246, 9879754, 9879755, 9880630, 9885376, 9886127, 9886150, 9889117, 9889118, 9896073, 9896079, 9898916, 9899409, 9905053, 9914662, 9914664, 9951987, 9953209, 9954653, 9955080, 9962340, 9964925, 9964932, 9964933, 9972391, 9972392, 9975062, 9979217, 9983473, 10002996, 10003686, 10014769, 10017111, 10026931, 10031165, 10032632, 10034838, 10036286, 10036287, 10044003, 10044004, 10044005, 10051493, 10053662, 10053663, 10053664, 10071125, 10071127, 10071130, 10076492, 10076493, 10076494, 10076495, 10087478, 10087479, 10087481, 10097088, 10097089, 10097090, 10103752, 10103753, 10112428, 10112429, 10112431, 10112432, 10120939, 10135522, 10135524, 10135526, 10135529, 10197760, 10197768, 10197776, 10197781, 10282249, 10282251, 10282252, 10282254, 10282255, 10296725, 10296728, 10307473, 10307474, 10315453, 10315454, 10315455, 10315456, 10325134, 10325135, 10335048, 10347695, 10347696, 10347698, 10347700, 10365897, 10365898, 10372654, 10372656, 10375862, 10375863, 10398877, 10398878, 10398879, 10398880, 10407000, 10428853, 10444975, 10446876, 10469219, 10472750, 10472751, 10475205, 10480924, 10480926, 10480927, 10485845, 10485846, 10485847, 10488358, 10495393, 10495394, 10495398, 10497009, 10500586, 10519438, 10527121, 10535508, 10535509, 10537711, 10541287, 10541288, 10561651, 10561652, 10561653, 10561654, 10561656, 10582159, 10582161, 10582163, 10587526, 10590657, 10590658, 10590660, 10590661, 10656233, 10656234, 10656235, 10656236, 10665853, 10665854, 10665855, 10671984, 10671991, 10675076, 10686976, 10686977, 10686978, 10686979, 10691192, 10691195, 10711510, 10806542, 10806546, 10806551.

510(k) numbers

["K031623"]

PMA numbers

not on file

Product code

FZP

Firm FEI

1000116158

Firm city

Brooklyn Park

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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