Date Initiated by Firm |
December 07, 2005 |
Date Posted |
January 31, 2006 |
Recall Status1 |
Terminated 3 on August 07, 2007 |
Recall Number |
Z-0409-06 |
Recall Event ID |
34163 |
510(K)Number |
K052038
|
PMA Number |
P950020 |
Product Classification |
Catheter, Coronary, Atherectomy - Product Code MCX
|
Product |
The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. This process, referred to as AtherotomyQ3J, allows dilatation of the target lesion with less pressure. The device is provided in 6 mm, 10 mm, and 15 mm lengths. The working length is the distance between the radiopaque marker bands. The proximal catheter shaft of the Flextome Cutting Balloon Device is a hypotube. This hypotube contains the inflation lumen for the balloon. The distal shaft is made of flexible material and contains two lumens. One lumen is for balloon inflation, and the second lumen is a guidewire lumen. The distal shaft is coated with a hydrophilic coating. The guidewire lumen is colored green for greater visibility. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchanges. A needle with a luer port is included for flushing the wire lumen prior to the insertion of appropriate coronary guide wires. CLlPIT1M clips are provided to aid in handling of the catheter.
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Code Information |
Lot/Batch# EF0341 EF0349 EF0350 EF0354 EF5047 EF5048 EF5093 EF5098 EF51 05 EF5168 EF5169 EF5170 EF5390 EF5396 EF5398 EF5404 EF5574 EE0914E EF5046 EF5068 EF5198 EF5329 EF5562 EE0885E EE0939E EF0411 EF0429 EF5050 EF5051 EF5056 EF5095 EF5194 EF5273 EF5285 EF5341 EF5478 EF5566 EF5566'' EE0916E EF5007 EF5086 EF5391 EE0937E EF0351 EF5096 EF5235 EF5567 EE0915E EF5067 EE0943E EF5230 EF0213 EF5101 EF5172 EF5236 EF5573 EF0342 EF5217 EF5403 EE0924E EF5102 EF5242 EF5296 EF5479 EE0932E EF5286 EE0933E EF5209 EF5392 EFO028E EF5004 EF5091 I EF5229 EF5291 EF5564 EF0339 EF5222 EF5261 EF5397 EE0880E EF0340 EF0343 EF0419 EF5092 EF5097 EF5100 EF51 04 EF5195 EF5243 EF5280 EF5287 EF5315 EF5331 EF5476 EF5485 EF5537 EF5563 EF0348 EF0353 EF5006 EF5171 EF5197 EF5314 EF5389 EF5497 EF5575 EF5368 EF5383 EF5363 EF5402 EF5379 EF5386 EF5387 EF5409 EF5401 EF5384 EF5571 EE0940E EF5008 EF5282 EE0904E EF0370 EF5049 EF5200 EF5272 EF5292 EF0345 EF5099 EF0204 EF5050 EF5267 EF5294 EE0917E EF5293 EE0906E EF5196 EF5388 EF5360 EF5385 EF5361 EF5588 EF5589 EFO057 EFO097 EF5109 EF5311 EF5481 EF5556 EFO033 EFO067 EF0150 EF0167 EF0407 EF5015 EF5020 EF5063 EF5110 EF5149 EF5249 EF5446 EF5461 EF5462 EF5551 EF5561 EF5615 EF0202 EF0315 EF0316 EF0317 EF0426 EF5073 EF5122 EF5441 EF5460 EF5501 EF5550 EF5586 EF5607 EFO041 EFO056 EFO078 EF0147 EF0163 EF0166 EF0193 EF0304 EF0319 EF0320 EF0409 EF5014 EF5016 EF5025 EF5114 EF5123 EF5139 EF5144 EF5145 EF5151 EF5183 EF5299 EF5300 EF5301 EF5302 EF5312 EF0208 EF5021 EF5023 EF5024 EF5027 EF5031 EF5037 EF5058 EF5065 EF5115 EF5132 EF5140 EF5585 EFO059 EFO068 EFOO77 EFO080 EFO095 EF0152 EF0162 EF0165 EF0201 EF0207 EF0305 EF0406 EF5022 EF5041 EF5060 EF5070 EF5085 EF5124 EF5125 EF5126 EF5127 EF5130 EF5147 EF5157 EF5158 EF5178 EF5185 EF5238 EF5248 EFO058 EFO069 EF0107 EF0158 EF0301 EF5083 EF5089 EF5116 EF5131 EF5146 EF5557 EE0881 E EFO074 EF0127 EF0128 EF0129 EF0131 EF0132 EF0155 EF0168 EF5084 EF5090 EF5159 EF5179 EF5221 EF5241 EF5250 EF5558 EFOO08 EF0187 EF0323 EF5044 EF5045 EF5057 EF5121 EF5447 EF5500 EF5502 EF5606 EF01 06 EF0395 EF0424 EF5119 EF5150 EF5448 EF5498 EF5540 EF5580 EF0192 EF0199 EF0303 EF0396 EF0397 EF0398 EF5029 EF5035 EF5052 EF5088 EF5120 EF5141 EF5155 EF5156 EFO079 EF0157 EF0186 EF5079 EF5134 EF5451 EF5499 EF5541 EFOO09 RB43 EF0198 EF0302 EF5013 EF5017 EF5053 EF5059 EF5076 EF5148 EF5152 EF5310 EF5450 EF5503 EFOO07 EF0185 EF0292 EF5237 EF5452 EF5470 EF5548 EF0161 EF0322 EF5039 EF5080 EF5111 EF5440 EF5506 EF5549 EFO081 EF0299 EF5018 EF5465 EF5504 EF5555 EFO075 EFO093 EFO098 EF0115 EF0149 EF0151 EF0205 EF5087 EF5240 EF5251 EFO018
EFO094 EF5077 EF5420 EF5469 EF5519 EFO066 EF0105 EF0368 EF0379 EF5072 EF5078 EF5081 EF5112 EF5463 EF0428 EF5192 EF5262 EE0925E EF5207 EF5263 EE0934E EF0360 EF5094 EF5208 EF527 4 EF5279 EF5477 EF5565 EE0941 E EF5005 EF5193 EF5265 EF5496 EF0352 EF0369 EF5103 EF5106 EF5216 EF5330 EF5486 EF5572 EFO017 EFO032 EF0114 EF0117 EF0321 EF5422 EF5521 EF5527 EFO016 EF0104 EF0116 EF0124 EF0148 EF0189 EF0365 EF0366 EF5107 EF5135 EF5532 EF5553 EFO052 EF0159 EF0296 CBM335015 EF0297 EF5074 EF5082 EF5464 EF5480 EF5505 EF5584 EF0408 EF0410 EF5061 EF5075 EF5475 EF5533 EF5587 EFO030 EF5033 EF5064 EF5108 EF5219 EF5220 EF5254 EF5449 EF5552 EF5599 EFO082 EF0421 EF5239 EF5252 EF5442 EF5518 EFO031 EF0156 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 3574 Ruffin Rd San Diego CA 92123-2597
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For Additional Information Contact |
Abe Mathews 408-895-3981
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Manufacturer Reason for Recall |
The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.
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FDA Determined Cause 2 |
Other |
Action |
All affected direct accounts will be given notification by Overnight mail 1/26/2006. 100% of the total number of customers are to be contacted. |
Quantity in Commerce |
qty in US:25,311 |
Distribution |
Nationwide plus Argentina Austria Belgium Brunei
Canada
Chile
China Colombia Czech Republic Denmark Finland
France Germany Great Britain Hong Kong Hungary
India Indonesia Ireland
Israel
Italy
Latvia Lebanon Luxembourg Macau Malaysia Mexico Netherlands Norway Poland Portugal Puerto Rico Saudi Arabia. Singapore South Africa Spain
Sweden Switzerland & Turkey |
Total Product Life Cycle |
TPLC Device Report
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = MCX and Original Applicant = Boston Scientific Corporation
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